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A Prospective Randomized Trial of Surgeon-Administered Intraoperative Transversus Abdominis Plane Block With Bupivacaine Against Liposomal Bupivacaine: The TINGLE Trial.
Truong, A, Fleshner, PR, Mirocha, JM, Tran, HP, Shane, R, Zaghiyan, KN
Diseases of the colon and rectum. 2021;(7):888-898
Abstract
BACKGROUND Transversus abdominis plane blocks are increasingly used to achieve opioid-sparing analgesia after colorectal surgery. Traditionally, bupivacaine was the long-acting analgesic of choice, but the addition of dexamethasone and/or epinephrine to bupivacaine may extend block duration. Liposomal bupivacaine has also been suggested to achieve an extended analgesia duration of 72 hours but is significantly more expensive. OBJECTIVE The purpose of this study was to compare pain control between laparoscopic transversus abdominis plane blocks using liposomal bupivacaine versus bupivacaine with epinephrine and dexamethasone. DESIGN This was a parallel-group, single-institution, randomized clinical trial. SETTINGS The study was conducted at a single tertiary medical center. PATIENTS Consecutive patients between October 2018 to October 2019, ages 18 to 90 years, undergoing minimally invasive colorectal surgery with multimodal analgesia were included. INTERVENTIONS Patients were randomly assigned 1:1 to receive a laparoscopic transversus abdominis plane block with liposomal bupivacaine or bupivacaine with epinephrine and dexamethasone. MAIN OUTCOME MEASURES The primary outcome was total oral morphine equivalents administered in the first 48 hours postoperatively. Secondary outcomes included pain scores, time to ambulation and solid diet, hospital length of stay, and complications. RESULTS A total of 102 patients (50 men) with a median age of 42 years (interquartile range, 29-60 y) consented and were randomly assigned. The primary end point, total oral morphine equivalents administered in the first 48 hours, was not significantly different between the liposomal bupivacaine group (median = 69 mg) and the bupivacaine with epinephrine and dexamethasone group (median = 47 mg; difference in medians = 22 mg, (95% CI, -17 to 49 mg); p = 0.60). There were no significant differences in pain scores, time to ambulation, time to diet tolerance, time to bowel movement, length of stay, overall complications, or readmission rate between groups. There were no treatment-related adverse outcomes. LIMITATIONS This study was not placebo controlled or blinded. CONCLUSIONS This first randomized trial comparing laparoscopic transversus abdominis plane block with liposomal bupivacaine or bupivacaine with epinephrine and dexamethasone showed that a liposomal bupivacaine block does not provide superior or extended analgesia in the era of standardized multimodal analgesia protocols.See Video Abstract at http://links.lww.com/DCR/B533. ESTUDIO PROSPECTIVO Y RANDOMIZADO DE BLOQUEO DEL PLANO MUSCULAR TRANSVERSO DEL ABDOMEN REALIZADO POR EL CIRUJANO CON BUPIVACANA VERSUS BUPIVACANA LIPOSOMAL ESTUDIO TINGLE ANTECEDENTESEl bloqueo anestésico del plano muscular transverso del abdomen se utiliza cada vez más para lograr una analgesia con menos consumo de opioides después de cirugía colorrectal. Tradicionalmente, la Bupivacaína era el analgésico de acción prolongada de elección, pero al agregarse Dexametasona y/o Adrenalina a la Bupivacaína se puede prolongar la duración del bloqueo. También se ha propuesto que la Bupivacaína liposomal logra una duración prolongada de la analgesia de 72 horas, pero es significativamente más cara.OBJETIVOComparar el control del dolor entre bloqueo laparoscópico del plano de los transversos del abdomen usando Bupivacaína liposomal versus Bupivacaína con Adrenalina y Dexametasona.DISEÑO:Estudio clínico prospectivo y randomizado de una sola institución en grupos paralelos.AJUSTECentro médico terciario único.PACIENTESTodos aquellos pacientes entre 18 y 90 años sometidos a cirugía colorrectal mínimamente invasiva con analgesia multimodal, entre octubre de 2018 a octubre de 2019 incluidos de manera consecutiva.INTERVENCIONESLos pacientes fueron seleccionados aleatoriamente 1:1 para recibir un bloqueo laparoscópico del plano de los transversos del abdomen con Bupivacaína liposomal o Bupivacaína con Adrenalina y Dexametasona.PRINCIPALES MEDIDAS DE RESULTADOEl resultado primario fue el total de equivalentes de morfina oral administradas en las primeras 48 horas después de la operación. Los resultados secundarios incluyeron puntuaciones de dolor, inicio de dieta sólida, tiempo de inicio a la deambulación, la estadía hospitalaria y las complicaciones.RESULTADOSUn total de 102 pacientes (50 hombres) con una mediana de edad de 42 años (IQR 29-60) fueron incluidos aleatoriamente. El criterio de valoración principal, equivalentes de morfina oral total administrada en las primeras 48 horas, no fue significativamente diferente entre el grupo de Bupivacaína liposomal (mediana = 69 mg) y el grupo de Bupivacaína con Adrenalina y Dexametasona (mediana = 47 mg; diferencia en medianas = 22 mg, IC del 95% [-17] - 49 mg, p = 0,60). No hubo diferencias significativas en las puntuaciones de dolor, tiempo de inicio a la deambulación, el tiempo de tolerancia a la dieta sólida, el tiempo hasta el primer evacuado intestinal, la duración de la estadía hospitalaria, las complicaciones generales o la tasa de readmisión entre los grupos. No hubo resultados adversos relacionados con el tratamiento.LIMITACIONESEste estudio no fue controlado con placebo ni de manera cegada.CONCLUSIONESEste primer estudio prospectivo y randomizado que comparó el bloqueo del plano de los músculos transversos del abdomen por vía laparoscópica, utilizando Bupivacaína liposomal o Bupivacaína con Adrenalina y Dexametasona, demostró que el bloqueo de Bupivacaína liposomal no proporciona ni mejor analgesia ni un efecto mas prolongado.Consulte Video Resumen en http://links.lww.com/DCR/B533.
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Abdominal Ice after Laparoscopic Hysterectomy: A Randomized Controlled Trial.
Cope, AG, Wetzstein, MM, Mara, KC, Laughlin-Tommaso, SK, Warner, NS, Burnett, TL
Journal of minimally invasive gynecology. 2021;(2):342-350.e2
Abstract
STUDY OBJECTIVE To assess the impact of abdominal ice packs on opioid use and pain control after laparoscopic hysterectomy DESIGN Randomized controlled trial. SETTING Academic tertiary care medical center. PATIENTS Total of 142 adult women undergoing laparoscopic (either conventional or robotic) hysterectomy were randomized to control (n = 69) or intervention (n = 73). Exclusion criteria included preoperative opioid use, planned intensive care unit admission or same-day discharge, an incision ≥4 cm, and regional anesthesia use. INTERVENTIONS Subjects in the intervention group had a large ice pack placed directly on the lower abdomen before leaving the operating room. The ice pack was maintained continuously for 12 hours postoperation, as desired thereafter until discharge, and continued use encouraged after discharge for up to 48 hours. MEASUREMENTS AND MAIN RESULTS Total opioids administered postoperatively, while inpatient and after dismissal, were assessed in morphine milligram equivalents. Postoperative pain, as well as analgesia acceptability and side effects, were assessed using validated measures: Brief Pain Inventory and Overall Benefit of Analgesia Score. Median morphine milligram equivalent was lower in the intervention group than the controls from inpatient stay on the floor to completion of opioid use as an outpatient (22.5 vs 26.2) but was not statistically significant (p = .79). There was no significant difference between the groups in Brief Pain Inventory assessment of postoperative pain severity (p = .80) or pain interference (p = .36) or Overall Benefit of Analgesia Score total score (p = .88). Most patients in the intervention group were very satisfied with ice pack use (n = 51, 79.7%) and very likely to recommend it to friends or family (n = 54, 83.1%). There were no adverse events related to ice pack use. CONCLUSION There was no significant difference in postoperative opioid use or pain assessment with ice pack use after laparoscopic hysterectomy. However, most of the subjects expressed high satisfaction specific to ice pack use and would recommend its use to others, suggesting potential desirability as adjunct therapy in postoperative pain control.
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Ketorolac plus Lidocaine vs Lidocaine for pain relief following core needle soft tissue biopsy: A CONSORT-compliant double-blind randomized controlled study.
Chobpenthai, T, Ingviya, T, Thanindratarn, P, Jaiwithee, R, Sutthivaiyakit, K
Medicine. 2021;(7):e24721
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BACKGROUNDS The main objective of this study was to compare the pain control efficacy of local administration of Lidocaine with or without the nonsteroidal anti-inflammatory drug, Ketorolac, and local conventional Lidocaine injection in core needle biopsy of the musculoskeletal tumor. METHODS The current study was a randomized, double-blind controlled clinical trial that included 128 patients with suspected musculoskeletal tumors. Patients were randomly assigned to either the Ketorolac plus Lidocaine (n = 64) or Lidocaine group (n = 64). The Ketorolac - Lidocaine combination syringe contained 30 mg Ketorolac and 2% Lidocaine - adrenaline dosage, and the Lidocaine syringe contained 2% Lidocaine - adrenaline dosage. The level of pain after core needle biopsy was evaluated for each patient at 1, 6, 12, 24, 48, and >48 hours by a Visual Analog Scale (VAS). The mean VAS changes over time were compared between the Ketorolac plus Lidocaine and Lidocaine groups using a linear mixed model. RESULTS baseline information including mean age of patients in Lidocaine group (51.5 ± 19.4 years) and in Lidocaine - Ketorolac combination group (50.1 ± 18 years), diagnosis (malignant, benign, metastatic, infection), tumor location (upper and lower extremities, back), VAS score 1-hour post-operation (mild and moderate pain) were noted. The VAS score ratings were significantly lower in Lidocaine - Ketorolac combination group when compared to the Lidocaine group during the 1 to 24 hours post-operation time period. CONCLUSION Patients receiving Lidocaine - Ketorolac combination dosage had significantly lower VAS scores, and these results confirm that local injection of Lidocaine - Ketorolac combination had a superior pain-controlling effect during the first 24 hours after the biopsy procedure in comparison to Lidocaine injection alone, as measured by VAS score scale.
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Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial.
Moussa, M, Papatsoris, AG, Chakra, MA
The American journal of emergency medicine. 2021;:395-400
Abstract
OBJECTIVES We aimed to evaluate the efficacy of intracutaneous sterile water injection (ISWI) to relieve the pain of acute renal colic compared with diclofenac and placebo. METHODS The study included 150 patients presented to the Emergency Department with renal colic randomized into 3 groups: control group received intracutaneous injections of 0.5 cm3 isotonic saline in the flank, group A received intracutaneous injections of 0.5 cm3 ISWI in the flank, and group B received an intramuscular injection of 75 mg Diclofenac in the gluteal region. The severity of the pain was assessed by a visual analogue scale system at baseline and 30, 45 min, and 60 min after injections. Subjects with inadequate pain relief at 1 h received rescue analgesia. RESULTS The mean baseline pain score was 9.6 ± 0.61 in the ISWI group, 9.72 ± 0.64 in the diclofenac group and 9.26 ± 0.89 in the control group. The mean pain score at 30 min of the control group was reduced to 6.9 ± 1.56. This mean at 30 min after ISWI and diclofenac injections were reduced to 1.98 ± 1.41 and 1.88 ± 1.19 respectively. The mean of pain sore of the ISWI and diclofenac group at 45 and 60 min was constant. Rescue analgesics at 1 h were required by 47 patients receiving the saline injection and by 4 patients and by 7 patients receiving ISWI and diclofenac injection respectively. CONCLUSIONS ISWI and diclofenac were equally effective for the pain relief of acute renal colic.
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Cool Crosslinking: Riboflavin at 4°C for Pain Management After Crosslinking for Keratoconus Patients, A Randomized Clinical Trial.
Toro-Giraldo, L, Morales Flores, N, Santana-Cruz, O, Ramirez-Miranda, A, Navas, A, Olivo-Payne, A, Lichtinger, A, Jimenez-Corona, A, Graue-Hernández, EO
Cornea. 2021;(1):1-4
Abstract
PURPOSE To explore corneal cooling as a method of pain management in corneal-accelerated collagen cross-linking. METHODS This was a prospective and interventional randomized clinical trial registered in the National Institutes of Health Clinical Trials through the identifier NCT030760770. The research was conducted at the Institute of Ophthalmology "Conde de Valenciana." A total of 98 patients were randomly assigned to one of the following 2 groups: cold riboflavin (4°C) group or control group (riboflavin at room temperature). The inclusion criteria were patients of any sex, older than 18 years of age with keratoconus diagnosis who needed management with cross-linking in both eyes because of the evidence of progression. The exclusion criteria were patients who had cross-linking without epithelial debridement, unilateral cross-linking, or any other ocular pathologies besides keratoconus and any cognitive incapacity that would make the understanding of the pain test difficult. The main outcome measures were pain, tearing, photophobia, foreign body sensation, and irritation. RESULTS At 2 hours post-op, pain in the case and control groups was 3.80 ± 3.00 and 8.08 ± 2.21 (P < 0.05), tearing was 1.56 ± 1.96 and 8.29 ± 2.42 (P < 0.05), photophobia was 5.44 ± 3.57 and 7.83 ± 2.64 (P < 0.05), foreign body sensation was 2.20 ± 2.78 and 6.54 ± 2.73 (P < 0.05), and irritation was 3.48 ± 2.98 and 6.79 ± 3.00 (P < 0.05), respectively. A statistical significant difference was maintained in pain values on day 1 (2.79 ± 3.09 and 4.91 ± 3.27 [P < 0.05]), 2 (2.54 ± 2.41 and 4.00 ± 2.43 [P < 0.05]), and 4 (0.45 ± 0.76 and 1.22 ± 1.67 [P < 0.05]). CONCLUSIONS This study demonstrated that pain and associated symptoms decreased significantly in the riboflavin 4°C group.
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Intravenous magnesium sulfate vs. morphine sulfate in relieving renal colic: A randomized clinical trial.
Zolfaghari Sadrabad, A, Azimi Abarghouei, S, Farahmand Rad, R, Salimi, Y
The American journal of emergency medicine. 2021;:188-192
Abstract
OBJECTIVE Renal colic emerging from renal stone is virtually the most severe pain which is experienced. Intravenous infusion of morphine sulfate is known as a usual treatment for the disease. This study was designed to compare the efficacy of magnesium sulfate vs morphine sulfate in renal colic relief as for analgesic effect as well as lack of morphine sulfate side effects when using magnesium sulfate. METHODS We conducted a double-blind randomized clinical trial in renal colic patients who had referred to the emergency department of Shahid Sadoughi Hospital in Yazd, Iran. A total of 80 eligible patients were selected and randomly assigned into two groups; patients in the case group received 50 mg/kg intravenous magnesium sulfate, and those in the control group 0.1 mg/kg intravenous morphine. The primary outcome was the pain score measured on a numerical rating scale at 0, 10 and 20 minutes after infusion. Data were analyzed using SPSS16. RESULTS The two groups were similar in terms of demographic features and pain intensity at the time of referral (P <.0001). Ten minutes after drug administration, the pain mean score in the morphine group leveled at 4.88, and in the magnesium group 5.70, which proved to be greater in the morphine group (P- = 0.06). However, the pain mean score turned out to be 3.65 in the morphine group and 3.20 in the magnesium group thus significantly indifferent (P = .48). CONCLUSIONS In this study, we concluded that administration of intravenous 50 mg/kg magnesium sulfate could be as effective as morphine in reducing renal colic without any further complications.
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The effectiveness of intradermal sterile water injection for low back pain in the emergency department: A prospective, randomized controlled study.
Tekin, E, Gur, A, Bayraktar, M, Ozlu, I, Celik, BK
The American journal of emergency medicine. 2021;:103-109
Abstract
AIM: Low back pain (LBP) is a common musculoskeletal complaint among emergency department (ED) admissions. In this study, it was aimed to compare the effectiveness of systemic treatment with intradermal sterile water injection (ISWI) treatment protocol combined with systemic therapy in patients with LBP of unclear chronicity. METHODS A prospective randomized, unblinded, controlled clinical study was conducted on patients admitted to the ED for LBP of unclear chronicity. One hundred twelve patients were randomly assigned to two groups; Group ISWI (n = 56) administered ISWI in the LBP region of patients along with systemic intravenous dexketoprofen therapy, while the other group (n = 56) received only systemic intravenous dexketoprofen therapy. The treatment methods' effectiveness was compared by measuring the pain intensity with the Visual Analog Scale (VAS) at admission, 10th minutes, 20th minutes, 30th minutes, and 24 h later. Also, opioid and analgesic consumptions in 24 h after treatment and patient satisfactions were compared. RESULTS In the treatment of LBP, ISWI treatment was found to be more effective in relieving pain than systemic therapy alone (p < 0.001). Also, it was observed that opioid consumption in the ED and analgesic consumption within 24 h after treatments were decreased in the ISWI group (p < 0.001). The patient satisfaction in the ED was statistically increased (p < 0.001). DISCUSSION In this unblinded study, ISWI with systemic therapy improved pain outcomes more than systemic therapy alone. Further research is needed to determine whether this was due entirely to placebo effect.
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Anterior Quadratus Lumborum Block Does Not Provide Superior Pain Control after Hip Arthroscopy: A Double-blinded Randomized Controlled Trial.
Haskins, SC, Tseng, A, Zhong, H, Mamic, M, Cheng, SI, Nejim, JA, Wetmore, DS, Coleman, SH, Ranawat, AS, Nawabi, DH, et al
Anesthesiology. 2021;(3):433-441
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BACKGROUND Hip arthroscopy is associated with moderate to severe postoperative pain. This prospective, randomized, double-blinded study investigates the clinically analgesic effect of anterior quadratus lumborum block with multimodal analgesia compared to multimodal analgesia alone. The authors hypothesized that an anterior quadratus lumborum block with multimodal analgesia would be superior for pain control. METHODS Ninety-six adult patients undergoing ambulatory hip arthroscopy were enrolled. Patients were randomized to either a single-shot anterior quadratus lumborum block (30 ml bupivacaine 0.5% with 2 mg preservative-free dexamethasone) or no block. All patients received neuraxial anesthesia, IV sedation, and multimodal analgesia (IV acetaminophen and ketorolac). The primary outcome was numerical rating scale pain scores at rest and movement at 30 min and 1, 2, 3, and 24 h. RESULTS Ninety-six patients were enrolled and included in the analysis. Anterior quadratus lumborum block with multimodal analgesia (overall treatment effect, marginal mean [standard error]: 4.4 [0.3]) was not superior to multimodal analgesia alone (overall treatment effect, marginal mean [standard error]: 3.7 [0.3]) in pain scores over the study period (treatment differences between no block and anterior quadratus lumborum block, 0.7 [95% CI, -0.1 to 1.5]; P = 0.059). Postanesthesia care unit antiemetic use, patient satisfaction, and opioid consumption for 0 to 24 h were not significantly different. There was no difference in quadriceps strength on the operative side between groups (differences in means, 1.9 [95% CI, -1.5 to 5.3]; P = 0.268). CONCLUSIONS Anterior quadratus lumborum block may not add to the benefits provided by multimodal analgesia alone after hip arthroscopy. Anterior quadratus lumborum block did not cause a motor deficit. The lack of treatment effect in this study demonstrates a surgical procedure without benefit from this novel block.
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Liquid combination of hyaluronan, glucosamine, and chondroitin as a dietary supplement for knee osteoarthritis patients with moderate knee pain: A randomized controlled study.
Wang, SJ, Wang, YH, Huang, LC
Medicine. 2021;(40):e27405
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BACKGROUND Hyaluronan (HA), glucosamine, and chondroitin sulfate are widely consumed as dietary supplements for the treatment of knee osteoarthritis (OA). This study aimed to explore the efficacy and safety of a dietary liquid supplement mixture containing HA, glucosamine, and chondroitin in patients with knee OA who had moderate knee pain (visual analogue scale of 4-6 points). METHODS This was a short-term, randomized, double-blind, placebo-controlled study. Subjects were allocated to administer either a bottle of 20 mL supplement mixture (50 mg HA plus 750 mg glucosamine plus 250 mg chondroitin, namely A + HA) or placebo once daily for 8 weeks. Outcome measures included the Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, 36-item Short Form Survey (SF-36), Chinese version of Pittsburgh Sleep Quality Index, and incidence of adverse event were evaluated at the end of week 8. Efficacy analyses were conducted in the modified intent-to-treat population. RESULTS Of the 80 subjects in the modified intent-to-treat population, 39 received A + HA while 41 received placebo. After 8 weeks of treatment, the A + HA group failed to demonstrate a significant symptomatic efficacy and quality of life improvement in terms of Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, SF-36, and Chinese version of Pittsburgh Sleep Quality Index as compared to the placebo group. However, the mean changes in most of the SF-36 scale scores were numerically higher in the A + HA group than in the placebo group. No treatment-related adverse event was reported in both groups. CONCLUSIONS This present study found that the combination of liquid low molecular weight HA, glucosamine, and chondroitin oral supplement did not effectively improve knee OA pain and symptoms after short-term use in knee OA patients with moderate knee pain. However, these results should be interpreted with caution due to the intrinsic limitation of the study design.
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Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy participants - A randomized placebo-controlled trial.
Raj, JP, Venkatachalam, S, Racha, P, Bhaskaran, S, Amaravati, RS
Complementary therapies in medicine. 2020;:102522
Abstract
OBJECTIVE Curcuma longa has been widely used in Ayurveda for its medicinal properties and Turmacin was developed from C. longa as a standardized extract containing turmerosaccharides. In this clinical trial, the effect of Turmacin on knee joint discomfort in healthy adults subjected to strenuous physical activity was evaluated. DESIGN Double-blind, triple-arm, parallel-group, randomized placebo-controlled trial. SETTING Healthy participants from an urban tertiary care teaching hospital. INTERVENTION Healthy participants were randomized in 1:1:1 ratio to receive either Turmacin 0.5 g/1 g or placebo once daily for 84 days. The participants were subjected to 10-minute strenuous exercise. OUTCOME MEASURES Time to initial pain, final pain score on a visual analogue scale, range of movement (ROM) of knee and the force of contractions of muscles around the knee joint. RESULTS A total of n = 90 participants were recruited. The mean final pain scores were significantly lower in the Turmacin 1 g and Turmacin 0.5 g when compared with the placebo from day-7 and day-5 onwards respectively. The survival analysis consistently showed a decreased hazard for early onset of pain in both the Turmacin groups. On day-84, the difference in mean ROM between Turmacin 0.5 g and placebo was 4.79 degrees (p = 0.008) and that for Turmacin 1 g and placebo was 2.34 degrees (p = 0.306). The difference in muscle force for isokinetic contractions of the quadriceps at angular velocities of 120 and 180 was significant between Turmacin 0.5 g and placebo (p = 0.002 and p = 0.005 respectively) while that for Turmacin 1 g & Turmacin 0.5 g (p = 0.206 and p = 0.414 respectively) and Turmacin 1 g & Placebo (p = 0.046 and p = 0.037) were not significant. However, in the within group analysis participants in Turmacin 1 g group had better preserved muscle functions than Turmacin 0.5 g group at angular velocities of 120 and 180 when compared with placebo. CONCLUSION Turmacin (0.5 g and 1 g) was efficacious when compared to placebo in increasing the pain threshold and knee ROM in healthy participants with minor adverse events.