The Effect of Sub-Tenon's Bupivacaine on Oculocardiac Reflex during Strabismus Surgery and Postoperative Pain: A Randomized Clinical Trial.
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ABSTRACT:
SUBMITTER: Talebnejad MR
PROVIDER: S-EPMC5525499 | biostudies-other | 2017 Jul-Sep
REPOSITORIES: biostudies-other
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Project description:Objectives: To compare the possible benefits of the combination of dexamethasone-bupivacaine with articaine-epinephrine as an anaesthetic block after third molar surgery. Materials and Methods: Triple-blind, randomized, controlled, parallel, phase 3 clinical trial. Two groups: experimental (93 patients) with standard anaesthetic block: 40/0.005 mg/mL articaine-epinephrine and submucosal reinforcement with 0.8 mg dexamethasone-5% bupivacaine; and control group (91 patients) with standard block: 40/0.005 mg/mL articaine-epinephrine. The surgery consisted of the extraction of the impacted mandibular third molar by performing a procedure following the same repeatable scheme. The visual analogue scale (VAS) was used to analyse postoperative pain. Results: Groups were homogeneous, without significant differences related to epidemiological variables. Postoperative pain among the first, second, and seventh postoperative days was statistically significantly lower in the experimental group compared to the control group (p < 0.001). Drug consumption was lower in the experimental group throughout the study period (p < 0.04). Conclusion: Bupivacaine is an alternative to articaine in oral surgery, being more effective in reducing postoperative pain by reducing patients' scores on the VAS as well as their consumption of analgesic drugs after surgery.
| S-EPMC8584321 | biostudies-literature
Project description:ImportanceLiposomal bupivacaine for pain relief is purported to last 3 days compared with 8 hours with standard bupivacaine. However, its effectiveness is unknown in truncal incisions for cardiothoracic or vascular operations.ObjectiveTo compare the effectiveness of single-administration standard bupivacaine vs liposomal bupivacaine in patients undergoing truncal incisions.Design, setting, and participantsThis randomized clinical trial enrolled patients undergoing sternotomy, thoracotomy, minithoracotomy, and laparotomy from a single cardiovascular surgery department in an academic medical center between November 2012 and June 2018. The study was powered to detect a Cohen effect size of 0.35 with a power of greater than 80%. Data analysis was performed from July to December 2018.InterventionPatients were randomized to standard bupivacaine or liposomal bupivacaine.Main outcomes and measuresPain was assessed over 3 postoperative days by the Numeric Rating Scale (NRS). Adjunctive opioids were converted to morphine equivalents units (MEU). NRS scores were compared using Wilcoxon rank-sum (3-day area under the curve) and 2-way nonparametric mixed models (daily scale score) to assess time-by-group interaction. Secondary outcomes included cumulative opioid consumption.ResultsA total of 280 patients were analyzed, with 140 in each group (single-administration standard bupivacaine vs liposomal bupivacaine). Mean (SD) age was 60.2 (14.4) years, and 101 of 280 patients (36%) were women. Irrespective of treatment assignment, pain decreased by a mean of approximately 1 point per day over 3 days (β = -0.87; SE = 0.11; mixed model regression P < .001). Incision type was associated with pain with patients undergoing thoracotomy (including minithoracotomy) reporting highest median (interquartile range [IQR]) pain scores on postoperative days 1 (liposomal vs standard bupivacaine, 6 [4-8] vs 5 [3-7]; P = .049, Wilcoxon rank-sum) and 2 (liposomal vs standard bupivacaine, 5 [4-7] vs 4 [2-6]; P = .003, Wilcoxon rank-sum) but not day 3 (liposomal vs standard bupivacaine, 3 [2-6] vs 3 [1-5]; P = .10, Wilcoxon rank-sum), irrespective of treatment group. Median (IQR) 3-day cumulative NRS was 12.0 (8.0-16.5) for bupivacaine and 13.5 (9.0-17.0) for liposomal bupivacaine (P = .15, Wilcoxon rank-sum) Furthermore, use of opioids was greater following liposomal bupivacaine compared with standard bupivacaine (median [IQR], 41.5 [21.3-73.8] MEU vs 33.0 [17.8-62.5] MEU; P = .03, Wilcoxon rank-sum). On multivariable analysis, no interaction by incision type was observed for mean pain scores or opioid use.Conclusions and relevanceIn this randomized clinical trial involving truncal incisions for cardiovascular procedures, liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 postoperative days.Trial registrationClinicalTrials.gov Identifier: NCT02111746.
| S-EPMC7967071 | biostudies-literature
Project description:BackgroundPostoperative nausea and vomiting (PONV) is one of the most frequent complications following strabismus surgery. Penehyclidine, an anticholinergic agent, is widely used as premedication. This study investigated the effect of preoperative penehyclidine on PONV in patients undergoing strabismus surgery.MethodsIn this prospective, randomized, double-blind study, patients scheduled for strabismus surgery under general anesthesia were randomly assigned to either penehyclidine (n?=?114) or normal saline (n?=?104) group. Penehyclidine was administrated immediately after anesthesia induction, and normal saline was substituted as control. PONV was investigated from 0 to 48?h after surgery. Intraoperative oculocardiac reflex (OCR) was also recorded.ResultsCompared with normal saline, penehyclidine significantly reduced PONV incidence (30.7% vs. 54.8%, P?< 0.01) and mitigated PONV severity as indicated by severity scoring (P?< 0.01). Compared with normal saline, penehyclidine also significantly reduced OCR incidence (57.9% vs. 77.9%, P?< 0.01) and mitigated OCR severity, as indicated by the requirement for atropine rescue (77.3% vs. 90.1%, P?< 0.05) and the maximum decrease of heart rate during OCR (23.1?±?9.4?bpm vs. 27.3?±?12.4?bpm, P <?0.05). The recovery course did not differ between groups.ConclusionsPenehyclidine administrated after anesthesia induction significantly reduced the incidence of PONV and alleviated intraoperative OCR in patients undergoing strabismus surgery.Trial registrationClinicalTrials.gov ( NCT04054479 ). Retrospectively registered August 13, 2019.
| S-EPMC7881589 | biostudies-literature
Project description:OBJECTIVE:Dexmedetomidine is known to reduce the incidence of emergence agitation, which is a common complication after inhalational anesthesia like sevoflurane or desflurane in children. However, the dose of dexmedetomidine used for this purpose is reported variously and the most effective dose is not known. In this study, we tried to find the most effective dose of dexmedetomidine to reduce the incidence of emergence agitation in children undergoing strabismus surgery without the complications like oculocardiac reflex (OCR) or postoperative vomiting. METHODS:We randomized 103 pediatric patients aged 2-6 years and undergoing elective strabismus surgery into four groups. Anesthesia was induced with sevoflurane and maintained with desflurane. At the start of induction, dexmedetomidine, delivered at 0.25, 0.5, or 1 ?g/kg, or saline was infused intravenously in the D0.25, D0.5, D1 groups, respectively. The primary outcome measure was the incidence of emergence agitation and the secondary outcome measure was the incidence of intraoperative OCR, postoperative vomiting, and desaturation events. RESULTS:The incidence of emergence agitation was 60, 48, 44, and 21% (P = 0.005) and the incidence of intraoperative OCR was 36, 36, 36, and 37% (P = 0.988) in the control, D0.25, D0.5, and D1 groups, respectively. And, postoperative vomiting rate and desaturation events were low in the all groups. CONCLUSION:Dexmedetomidine decreased the incidence of emergence agitation without increasing intraoperative oculocardiac reflex. Dexmedetomidine delivered at 1 ?g/kg was more effective at reducing emergence agitation than lower doses in children undergoing strabismus surgery under desflurane anesthesia. TRIAL REGISTRATION:Clinical Research Information Service KCT0000141.
| S-EPMC5019399 | biostudies-literature
Project description:BACKGROUND:Arthroscopic meniscus surgery can lead to pain at various levels. In this study, we aimed to compare, in patients undergoing arthroscopic meniscectomy under spinal anesthesia, the efficacy of the combination of magnesium sulfate and dexmedetomidine with local anesthetics administered intraarticularly for postoperative pain management Methods: This prospective, randomized, controlled, double-blind study comprised of 52 patients who were randomly assigned into two groups depending on the combination injected intraarticularly at the end of the procedure: bupivacaine and dexmedetomidine (group D) or bupivacaine and magnesium sulfate (group M). Perioperative data, postoperative visual analog scale (VAS) scores, and total analgesic consumption were recorded. CLINICAL TRIAL REGISTRATION:NCT03479216 Results: No statistically significant differences were found in mobilization times, rescue analgesic times, and non-steroidal anti-inflammatory consumption. The maximum mean VAS values at rest and during movement in group D were measured at the 6th hour while in group M peaked at the 8th hour. CONCLUSION:Both intraarticular dexmedetomidine and magnesium sulfate, in combination with bupivacaine, have similar effects on reducing postoperative pain in arthroscopic knee surgery. HIPPOKRATIA 2019, 23(2): 51-57.
| S-EPMC7127915 | biostudies-literature
Project description:IntroductionShoulder arthroscopy can result in substantial postoperative pain. Sucrose acetate isobutyrate extended-release bupivacaine (SABER-Bupivacaine; trade name Posimir) is a novel depot formulation of bupivacaine designed to provide analgesia at the surgical site for up to 72 hours. The objective of this study was to evaluate the effect of SABER-Bupivacaine on pain and opioid consumption after arthroscopic subacromial decompression and to assess short-term and long-term safety.MethodsIn this double-blind, placebo-controlled trial, 78 subjects were randomized in a 2:1 ratio to SABER-Bupivacaine 5 mL or SABER-placebo 5 mL injected into the subacromial space just before skin closure. Twenty-nine additional subjects were randomized on an exploratory basis to bupivacaine hydrochloride 20 mL, also injected subacromially. Subjects rated pain intensity on a 0 to 10 scale over the first 3 postoperative days and received intravenous or oral morphine for breakthrough pain. The coprimary efficacy end points were pain intensity on 90° shoulder flexion and cumulative morphine intake from 0 to 72 hours after surgery. The time to first use of opioid rescue analgesia was a secondary end point.ResultsThe mean (SD) pain intensity was 5.16 (1.94) for SABER-Bupivacaine and 6.43 (1.77) for placebo (P = 0.012). The median consumption of intravenous morphine equivalents was 4.0 mg for SABER-Bupivacaine and 12.0 mg for placebo (P = 0.010). The median time to first use of morphine rescue was 12.4 hours for SABER-Bupivacaine and 1.2 hours for placebo (P = 0.014). The corresponding values for bupivacaine hydrochloride were 5.16 (2.38), 8.0 mg, and 1.4 hours. The incidence and severity of treatment-emergent adverse events were similar for all treatment groups, and no functional or radiographic differences were noted at the 6-month follow-up.DiscussionCompared with placebo, SABER-Bupivacaine reduced pain and opioid analgesic consumption over 72 hours after arthroscopic subacromial decompression and prolonged the time to first use of opioid rescue analgesia. No safety signals were noted during the immediate postoperative period or at 6-month follow-up.
| S-EPMC10566886 | biostudies-literature
Project description:BackgroundPostoperative pain is a common, distressing symptom following arthroscopic knee surgery. The aim of this study was to compare the potential analgesic effect of dexmedetomidine after intrathecal versus intra-articular administration following arthroscopic knee surgery.MethodsNinety patients undergoing unilateral elective arthroscopic knee surgery were randomly assigned into three groups in a double-blind placebo controlled study. The intrathecal dexmedetomidine group (IT) received an intrathecal block with intrathecal dexmedetomidine, the intra-articular group (IA) received an intrathecal block and intra-articular dexmedetomidine, and the control group received an intrathecal block and intra-articular saline. The primary outcome of our study was postoperative pain as assessed by the visual analogue scale of pain (VAS). Secondary outcomes included the effect of dexmedetomidine on total postoperative analgesic use and time to the first analgesic request, hemodynamics, sedation, postoperative nausea and vomiting, patient satisfaction, and postoperative C-reactive protein (CRP) levels.ResultsDexmedetomidine administration decreased pain scores for 4 h in both the intrathecal and intra-articular groups, compared to only 2 h in the control patient group. Furthermore, there was a significant reduction in pain scores for 6 h in the intra-articular group. The time to the first postoperative analgesia request was longer in the intra-articular group compared to the intrathecal and control groups. The total meperidine requirement was significantly lower in the intra-articular and intrathecal groups than in the control group.ConclusionsBoth intrathecal and intra-articular dexmedetomidine enhanced postoperative analgesia after arthroscopic knee surgery. Less total meperidine was required with intra-articular administration to extend postoperative analgesia to 6 h with hemodynamic stability.
| S-EPMC5392657 | biostudies-literature
Project description:BackgroundUpper extremity surgery is commonly performed in the ambulatory setting and is associated with moderate to severe postoperative pain.MethodsPatients scheduled for upper extremity orthopedic surgery with a peripheral nerve block were randomized to receive either an ultrasound-guided single-injection supraclavicular block or ultrasound-guided median, ulnar, and radial nerve blocks (forearm blocks) performed at the level of the mid to proximal forearm with liposomal bupivacaine (Exparel) combined with a short-acting supraclavicular block. A sham block was performed in an attempt to blind enrollees in the control group. We administered the EuroQol 5D-5L questionnaire preoperatively and on postoperative days 1-3 and considered the results the primary outcome of our investigation. Block procedure times, postanesthesia care unit (PACU) length of stay, instances of nausea/vomiting, need for narcotic administration, and patient satisfaction were also assessed.ResultsWe observed no significant differences in postoperative EuroQol scores between the 2 groups and no significant differences in patient demographics, PACU length of stay, or side effects in the PACU. In some instances, the short-acting supraclavicular block resolved in the PACU, and these patients reported higher pain scores and required titration of analgesics prior to discharge.ConclusionLarger prospective studies are needed to determine the safety and efficacy of liposomal bupivacaine in patients undergoing upper extremity surgery. Liposomal bupivacaine is currently only approved for local anesthetic infiltration use.
| S-EPMC5158147 | biostudies-literature
Project description:BackgroundSurgical extraction of the impacted mandibular third molar is commonly associated with postoperative pain, swelling, and trismus. Usually, rotatory instruments like burs have been used for osteotomy, while Piezosurgery is an innovative technique introduced to overcome the weaknesses related to the conventional technique. In addition, Dexamethasone administration before the extraction of impacted third molars is an efficient way to reduce postoperative pain due to robust anti-inflammatory activity. The purpose of the study is to evaluate the effect of piezo-surgery and dexamethasone injection on postoperative sequelae after the surgical extraction of impacted mandibular third molars, and ultimately to compare their effect on reducing postoperative pain.MethodsA randomized controlled clinical trial was conducted with a sample of 80 patients. Participants were divided into four groups: Group 1 (Conventional rotatory), Group 2 (Conventional rotatory with 8 mg dose of dexamethasone 30 min before surgery), Group 3 (Piezo-surgery), and Group 4 (Piezo-surgery with 8 mg dose of dexamethasone 30 min before surgery). The outcome variables were surgical working time calculated in minutes, maximal mouth opening measured in millimeters using Vernier Caliper at baseline and day 3 and postoperative pain assessed using a Visual Analog Scale (VAS) on days 1, 3, and 7.ResultsThe surgical working time was longer in piezo-surgery groups compared with the conventional rotatory instruments groups (15.82 ± 3.47 vs 23.33 ± 2.54; p value < 0.0001). The lowest reduction in mouth opening between baseline and 3rd-day post-op was found in the Piezo-surgery with Dexamethasone group (mean difference = 5.0, SD = 3.9, p value < 0.0001) followed by the Piezosurgery without Dexamethasone group (mean difference = 5.8, SD = 4.5, p value < 0.0001) and the highest average was reported by the Conventional rotatory without Dexamethasone (mean difference = 9.7, SD = 4.5, p value < 0.0001. In the four groups, the mean pain score was highest on the 1st day and gradually decreased over the following days. Comparison of the 1st and 3rd postoperative pain between groups revealed a lowest mean pain score in the Piezo-surgery with Dexamethasone group, followed by Conventional rotatory with Dexamethasone group and a highest mean score in the Conventional rotatory without Dexamethasone group (p value < 0.0001).ConclusionThe association of Piezosurgery osteotomy and Dexamethasone intramuscular injection could be an effective combination to reduce postoperative pain and trismus after impacted third molar surgery.Trial registrationNCT04889781 ( https://clinicaltrials.gov/ ), Date of Registration: 17/05/2021 (retrospectively registered), https://clinicaltrials.gov/ct2/show/NCT04889781?term=NCT04889781&draw=2&rank=1.
| S-EPMC8359387 | biostudies-literature
Project description:Importance:Intravenous acetaminophen is a commonly prescribed analgesic for the prevention and treatment of postsurgical pain. Its efficacy in the context of endoscopic sinus surgery (ESS) has yielded mixed results. Objective:To compare the efficacy of perioperative intravenous acetaminophen (IVAPAP) with that of placebo in improving early postoperative pain after endoscopic sinus surgery (ESS). Design, Setting, and Participants:A prospective, randomized clinical trial including 62 patients undergoing ESS for chronic rhinosinusitis in a single tertiary referral hospital. Interventions:Participants were randomized to receive 1 g of IVAPAP or 100 mL of placebo consisting of saline infusions immediately before the start of surgery and 4 hours after the initial dose. Main Outcomes and Measures:The primary outcome was postoperative pain measured by visual analog scale (VAS) scores up to 24 hours after surgery by blinded observers. Secondary endpoints included postoperative opioid (intravenous and oral) use and adverse events in the 24-hour postoperative period. Results:Of the 62 enrolled adult participants, 60 were randomized (31 to IVAPAP intervention and 29 to placebo). The mean (SD) age of participants was 53.7 (14.7) years and 35 (58%) of the participants were men and 25 (42%) were women. Within the first hour, mean pain scores were reduced in the IVAPAP group compared with the control group, reaching a maximum difference of 7.7 mm on a VAS scale favoring the treatment group with a true difference possibly as high as 22 mm, and the data are compatible with a clinically meaningful difference. At 12- and 24-hours, average pain scores were less in the placebo group and the data are compatible with a clinically meaningful difference of 5.8 (-5.2 to 16.8) and 8.2 (-1.9 to 18.4), respectively, favoring the placebo group. However, at all time points the CIs included the null value and were wide, thus preventing definitive conclusions. Inspection of the secondary outcomes favored IVAPAP, but the wide range of the CIs and inclusion of the null value prevent definitive conclusions. Conclusions and Relevance:The results of this study are inconclusive. The data suggest that perioperative intravenous acetaminophen may reduce immediate postoperative pain and opioid requirements compared with placebo and these differences could be clinically meaningful. Unfortunately, the imprecision of the estimates prevents definitive conclusion. Use of IVAPAP does not seem to increase adverse events. Trial Registration:clinicaltrials.gov Identifier: NCT01608308.
| S-EPMC5710551 | biostudies-literature