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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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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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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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Atomized intranasal vs intravenous fentanyl in severe renal colic pain management: A randomized single-blinded clinical trial.
Nazemian, N, Torabi, M, Mirzaee, M
The American journal of emergency medicine. 2020;(8):1635-1640
Abstract
OBJECTIVES Renal colic is one of the most common painful disorders in patients referred to the emergency department. The main purpose of this study was to compare the efficiency of two methods of intravenous (IVF) and intranasal (INF) fentanyl administration in pain management in patients with severe renal colic. MATERIALS & METHODS This was a single-blind randomized clinical trial performed on patients with severe renal colic. The severity of pain was ≥8 based on the Numerical Rating Scale (NRS). The efficacy of pain management was compared within and between the IVF (intramuscular Ketorolac + intravenous fentanyl) and INF (intramuscular Ketorolac + intranasal fentanyl) groups at different times points. Oral consent was obtained from all the patients. RESULTS Of 220 individuals, 96 (43.60%) were women and 124 (56.40%) were men. There were no significant differences between the two groups regarding the baseline pain severity, age, sex, history of urolithiasis and body mass index (BMI). The pain severity showed a significant reducing trend in both groups (p < 0.0001). There was also a significant difference comparing the mean pain severity between groups at different times (p < 0.0001). In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001). CONCLUSION Fentanyl is highly effective in controlling pain in patients with severe renal colic referring to the emergency department. Intranasal administration of fentanyl combination with ketorolac can be an appropriate, non-invasive, easy-to-use and fast alternative to the intravenous method to manage pain in these patients.
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The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial.
Förderreuther, S, Lampert, A, Hitier, S, Lange, R, Weiser, T
Advances in therapy. 2020;(6):2976-2987
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INTRODUCTION A fixed dose combination (FDC) of ibuprofen 400 mg and caffeine 100 mg has been shown to be more effective than ibuprofen 400 mg alone for the treatment of acute postoperative dental pain in a phase III randomised controlled trial. A post hoc subgroup analysis of the primary data from an active-/placebo-controlled, double-blind, single-centre, parallel-group study was conducted in patients with moderate or severe baseline pain. METHODS After dental surgery, patients with moderate or severe pain, which was determined on a 4-point verbal rating scale ('no pain' to 'severe pain'), received a single dose of ibuprofen 400 mg/caffeine 100 mg FDC, ibuprofen 400 mg, caffeine 100 mg or placebo. Pain relief (PAR) and pain intensity were assessed 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7 and 8 h after administration of study medication. The primary study endpoint was the time-weighted sum of PAR and pain intensity difference (PID) from pre-dose baseline, summed for all post-dose assessment times from 0 to 8 h (SPRID0-8h). RESULTS There were 237 patients with moderate pain and 325 with severe pain at baseline. SPRID0-8h was significantly improved with the FDC versus ibuprofen, caffeine and placebo in the moderate and severe pain subgroups. Adjusted mean SPRID0-8h difference for the FDC versus ibuprofen was 18.19 (p < 0.0001) for patients with moderate pain and 7.70 (p = 0.0409) for patients with severe pain. With the exception of the 7-h measurement in patients with moderate pain, PID was significantly improved with the FDC versus ibuprofen at all measured time points from 0.5 to 8 h. In the severe pain subgroup, PID was significantly improved for the FDC versus ibuprofen from 0.5 to 3 h post-dose, but was not significantly different thereafter. CONCLUSION The enhanced analgesic efficacy of ibuprofen/caffeine FDC versus ibuprofen is most pronounced in patients with moderate intensity pain at baseline, and also evident in patients with severe baseline pain. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT01929031.
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Efficacy of pethidine, ketorolac, and lidocaine gel as analgesics for pain control in shockwave lithotripsy: A single-blinded randomized controlled trial.
Hashem, A, Ghobrial, FK, Elbaset, MA, Atwa, AM, Fadallah, M, Laymon, M, El-Assmy, A, Sheir, KZ, Abol-Enein, H
Investigative and clinical urology. 2019;(4):251-257
Abstract
PURPOSE To compare the safety and efficacy of xylocaine gel and ketorolac as opioid-sparing analgesia compared with pethidine for shock wave lithotripsy (SWL) pain. MATERIALS AND METHODS A single-blinded randomized controlled trial (RCT) was performed in 132 patients with renal and upper ureteral stones amenable to treatment with SWL. The first patient group received intravenous (IV) pethidine and placebo gel; the second group received IV ketorolac plus placebo gel; the third group received lidocaine gel locally plus normal saline IV. Stone disintegration was classified as none (no change from basal by kidney, ureter, bladder X-ray or ultrasound [US] imaging), partial (fragmented and >4-mm residual fragments), and complete (≤4-mm residual fragments). Stone disintegration was assessed by kidney-ureter-bladder X-ray and US imaging. Pain was evaluated by use of the Numeric Pain Rating Scale (NPRS). RESULTS The NPRS scores were highest in the xylocaine group at 10, 20, and 30 minutes (p=0.0001) with no significant difference between the ketorolac and pethidine groups, except at 10 minutes (p=0.03) and a near significant difference at 30 minutes (p=0.054) in favor of ketorolac. Results for stone disintegration (none, partial, and complete, respectively) were as follows: 25 (50.0%), 23 (46.0%), and 2 (4.0%) for pethidine; 19 (35.8%), 23 (43.4%), and 11 (20.8%) for ketorolac; and 26 (89.7%), 3 (10.3%), and 0 (0.0%) for lidocaine (p=0.008). CONCLUSIONS Ketorolac is a safe and more effective alternative to morphine derivatives for SWL analgesia. Lidocaine gel should not be used as mono-analgesia for SWL.
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Which Combination Treatment Is Better for Spinal Metastasis: Percutaneous Vertebroplasty With Radiofrequency Ablation, 125I Seed, Zoledronic Acid, or Radiotherapy?
Lu, CW, Shao, J, Wu, YG, Wang, C, Wu, JH, Lv, RX, Ding, MC, Shi, ZC, Mao, NF
American journal of therapeutics. 2019;(1):e38-e44
Abstract
BACKGROUND Percutaneous vertebroplasty (PVP) can not only alleviate pain but also restore mechanical stability with injection of bone cement, whereas it exhibits a poor effect on antitumor activity. But through combinations with other therapies, it may be possible to achieve the maximum effect in clinical treatment. Thus, this study is designed to assess the clinical efficacy of PVP separately combined with 4 ways for spinal metastasis (SM) treatment. STUDY QUESTION Which combination treatment is better for spinal metastasis, percutaneous vertebroplasty with radiofrequency ablation, I seed, zoledronic acid or radiotherapy? STUDY DESIGN A total of 169 patients with SM were retrospectively recruited and randomly assigned to 4 groups to receive 4 different ways separately: 49 patients (group A) received PVP plus I seed, 51 (group B) received PVP plus radiofrequency ablation (RFA), 38 (group C) underwent PVP plus zoledronic acid (ZA), and 31 (group D) underwent PVP plus radiotherapy (RT). MEASURES AND OUTCOMES All of them underwent routine examinations before operation. Visual analog scale (VAS), World Health Organization (WHO) Pain Relief, and ODI were applied to evaluate pain relief and motor function. RESULTS PVP plus RT achieved the best efficacy in relieving pains, with the highest WHO Pain Relief (P < 0.05). The PVP plus RFA exhibited lowest ODI, suggesting the best outcome after treatment (P < 0.05). The PVP plus I showed the lowest VAS score, but it was the worst to improve the routine exercise ability and relieve pains from patients. The PVP plus ZA presented higher VAS and ODI (P < 0.05). CONCLUSIONS PVP combined with I seed exhibited the best clinical efficacy in terms of VAS, PVP combined with RT was the best choice in terms of WHO Pain Relief, and PVP combined with RFA showed the best effect in terms of ODI for the treatment of SM.
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Celecoxib versus ketorolac following robotic hysterectomy for the management of postoperative pain: An open-label randomized control trial.
Ulm, MA, ElNaggar, AC, Tillmanns, TD
Gynecologic oncology. 2018;(1):124-128
Abstract
OBJECTIVE Compare postoperative pain scores following hysterectomy in patients receiving perioperative celecoxib versus postoperative ketorolac as part of a multimodal pain regimen. METHODS Patients undergoing hysterectomy were randomized to receive scheduled intravenous ketorolac in the immediate postoperative period or oral celecoxib prior to surgery and continued for a total seven days. All patients received a common multimodal pain protocol consisting of scheduled acetaminophen, gabapentin, and opioids as needed. Inpatient pain scores and postoperative opioid use were analyzed. A questionnaire regarding outpatient opioid use and return to normal activities of daily living (ADLs) was returned two weeks postoperatively. RESULTS 192 patients were assessed for eligibility and 170 patients were randomized. Enrollment of patients undergoing open hysterectomy was closed prematurely for poor accruement (n = 32). 138 patients undergoing robotic hysterectomy were included were analyzed. There were no differences for inpatient pain scores (2.7 ± 1.9 v. 2.4 ± 1.6, p = 0.21). Average length of stay was similar between the two arms (11.6 ± 8.1 h v. 11.9 ± 7.6 h, p = 0.41). Patients in the celecoxib arm used less prescription opioids (6.0 ± 3.6 v. 8.1 ± 4.0, p = 0.001) and stopped using oral opioids earlier (3.8 ± 2.6 days v. 5.7 ± 2.8 days, p < 0.001). No differences were seen in inpatient opioid or anti-emetic usage, perioperative complications, or days to return to ADLs. CONCLUSIONS There was no difference in inpatient pain scores between patients who received celecoxib or ketorolac as part of multimodal pain control following robotic hysterectomy. Patients who received scheduled celecoxib for seven days after surgery used less prescription narcotics.
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Randomised crossover trial showed that using breast milk or sucrose provided the same analgesic effect in preterm infants of at least 28 weeks.
Collados-Gómez, L, Ferrera-Camacho, P, Fernandez-Serrano, E, Camacho-Vicente, V, Flores-Herrero, C, García-Pozo, AM, Jiménez-García, R
Acta paediatrica (Oslo, Norway : 1992). 2018;(3):436-441
Abstract
AIM: Repeated, ongoing exposure to pain influences the growth, cognitive and motor functions, behaviour, personality and neurodevelopment of preterm infants. We compared the analgesic effects of expressed breast milk (EBM) and 24% oral sucrose on preterm neonates during venipuncture. METHODS This multicentre randomised, noninferiority, crossover trial focused on five neonatal university units in Madrid, Spain, from October 2013 to October 2014. It comprised 66 preterm infants born at less than 37 weeks and randomly split into two groups. They received either EBM or sucrose two minutes before venepuncture, together with nonnutritive sucking and swaddling, then the opposite procedure at a later point. Pain was measured with the premature infant pain profile (PIPP) and crying was also measured. RESULTS There were no statistically significant differences between the groups. The PIPP scores were seven (4-9) with breast milk and six (4-8.25) with sucrose (p = 0.28). The 11 infants born at under 28 weeks of age showed higher median scores of nine (9-14) for breast milk and four (4-7) for sucrose (p = 0.009). CONCLUSION EBM and 24% sucrose had the same analgesic effect during venipuncture in most of the preterm neonates, but sucrose worked better in extremely preterm infants.
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Perineural Low-Dose Dexamethasone Prolongs Interscalene Block Analgesia With Bupivacaine Compared With Systemic Dexamethasone: A Randomized Trial.
Kahn, RL, Cheng, J, Gadulov, Y, Fields, KG, YaDeau, JT, Gulotta, LV
Regional anesthesia and pain medicine. 2018;(6):572-579
Abstract
BACKGROUND AND OBJECTIVES Perineural dexamethasone and intravenous (IV) dexamethasone have been shown to prolong peripheral nerve block duration. The effects of perineural and IV dexamethasone have only been compared at doses of 4 mg or greater. This triple-blind, randomized trial examined the effect of 1 mg IV versus perineural dexamethasone on interscalene block (ISB) analgesia duration. METHODS Patients undergoing ambulatory shoulder arthroscopy received an ultrasound-guided ISB with 15 mL bupivacaine 0.5% and 1 mg preservative-free dexamethasone that was administered perineurally (PeriD) or IV (IVDex). All patients received IV ketorolac and were discharged on naproxen 500 mg 2 times a day plus oxycodone/acetaminophen as needed. Peripheral nerve block duration, pain, opioid consumption, and block satisfaction were assessed via telephone follow-ups. RESULTS There were 63 PeriD patients and 62 IVDex patients who completed the primary outcome follow-up. The median time until analgesia from the ISB completely wore off was 3.5 hours (95% confidence interval, 1.0-6.0 hours) longer in the PeriD versus IVDex groups; P = 0.007). Time until the pain relief from the ISB began to wear off was also longer in the PeriD versus IVDex group (5.5 hours [95% confidence interval, 2.1-9.0 hours]; P = 0.002). Other secondary outcomes, including opioid consumption, satisfaction, and pain scores, were not different between groups. CONCLUSIONS In patients undergoing shoulder arthroscopy, low-dose perineural dexamethasone (1 mg) in combination with 15 mL of 0.5% bupivacaine prolonged the median time until pain relief from the ISB completely wore off compared with 1 mg IV dexamethasone. However, the degree of prolongation was smaller than the a priori-defined minimal clinically meaningful difference of 5 hours. CLINICAL TRIAL REGISTRATION This study was registered at Clinicaltrials.gov, identifier NCT02506660.