Transmuscular quadratus lumborum (TQL) block for laparoscopic colorectal surgery: study protocol for a double-blind, prospective randomized placebo-controlled trial.
ABSTRACT: BACKGROUND:Thoracic epidural anesthesia is no longer considered the gold standard for perioperative analgesia in laparoscopic colorectal procedures. In the search for alternatives, the efficacy of the transverse abdominal plane (TAP) block and other abdominal wall blocks such as the transmuscular quadratus lumborum (TQL) block continues to be investigated for postoperative pain management. Most of the initial studies on TAP blocks reported positive effects; however, the amount of studies with negative outcomes is increasing, most probably due to the fact that the majority of abdominal wall blocks fail to mitigate visceral pain. The TQL block could prove attractive in the search for better postoperative pain relief after laparoscopic colorectal surgery. In several cadaveric studies of the TQL, a spread of dye into the thoracic paravertebral space, the intercostal spaces, and even the thoracic sympathetic trunk was reported. Given the advantage of possibly reaching the thoracic paravertebral space, the potential to reach nerves transmitting visceral pain, and the possible coverage of dermatomes T4-L1, we hypothesize that the TQL provides superior postoperative analgesia for laparoscopic colorectal surgery as compared to patient-controlled intravenous analgesia with morphine alone. METHODS AND DESIGN:In this prospective, randomized, double-blind controlled clinical trial, 150 patients undergoing laparoscopic colorectal surgery will be included. Patients will be randomly allocated to two different analgesic strategies: a bilateral TQL with 30?ml ropivacaine 0.375% each on both sides, administered before induction of anesthesia, plus postoperative patient-controlled intravenous analgesia with morphine (TQL group, n?=?75), or a bilateral TQL block with 30?ml saline each on both sides plus postoperative patient-controlled intravenous analgesia with morphine (placebo group, n?=?75). Our primary outcome parameter will be the morphine consumption during the first 24?h postsurgery. Secondary endpoints include pain intensity as assessed with the numerical rating scale (NRS) for pain, time to return of intestinal function (defined as the time to first flatus and the time to the first postoperative intake of solid food), time to first mobilization, the incidence of postoperative nausea and vomiting during the first 24?h, length of stay on the post anesthesia care unit (PACU) and in the hospital, the extent of sensory block at two time points (admission to and discharge from the PACU), the doses of morphine IV as requested by the patient from the PCA pump, the total dosage of morphine administered IV, the need for and dose of rescue analgesics (ketamine, clonidine), free plasma ropivacaine levels after induction and at discharge from the PACU, and the incidence of adverse events during treatment (in particular, signs of local anesthetic systemic toxicity (LAST)). Epidural analgesia is no longer the standard of care for postoperative analgesia in laparoscopic colorectal surgery. Until now, the most effective analgesic strategy in these patients especially in an enhanced recovery program is still unknown. Several abdominal wall blocks (TAP, fascia transversalis plane block) are known to have an analgesic effect only on somatic pain. Recognizing the importance of procedure-specific pain management, we aim to investigate whether a transmuscular quadratus lumborum block delivers superior pain control in comparison to patient-controlled intravenous analgesia with morphine alone. TRIAL REGISTRATION:EudraCT identifier 2019-002304-40. Registered on 17 September 2019.
Project description:Despite the laparoscopic approach becoming the standard in colorectal surgery, postoperative pain management for minimally invasive surgery is still mainly based on strategies that have been established for open surgical procedures. Patient-controlled epidural and intravenous analgesia are considered standard postoperative analgesia regimens in colorectal surgery. Epidural analgesia provides excellent analgesia, but is increasingly scrutinized in laparoscopic surgery since postoperative pain after the laparoscopic approach is significantly reduced. Moreover, epidural analgesia can be associated with numerous complications. Therefore, epidural analgesia is no longer recommended for the management of postoperative pain in laparoscopic colorectal surgery. Likewise, patient-controlled intravenous analgesia is subject to significant side effects. Given these important limitations of the traditional strategies for postoperative analgesia, effective and efficient alternatives in patients undergoing laparoscopic colorectal surgery are needed. Both the transversus abdominis plane block and systemically administered lidocaine have already been reported to effectively reduce pain after laparoscopic colorectal surgery. We hypothesize that the transversus abdominis plane block is superior to perioperative intravenous lidocaine.One hundred and twenty five patients undergoing laparoscopic colorectal surgery will be included in this prospective, randomized, double-blind controlled clinical trial. Patients will be randomly allocated to three different postoperative strategies: postoperative patient-controlled intravenous analgesia with morphine (control group, n = 25), a transversus abdominis plane block with ropivacaine 0.375% at the end of surgery plus postoperative patient-controlled intravenous analgesia with morphine (TAP group, n = 50), or perioperative intravenous lidocaine plus postoperative patient-controlled intravenous analgesia with morphine (LIDO group, n = 50). As the primary outcome parameter, we will evaluate the opioid consumption during the first 24 postoperative hours. Secondary endpoints include the Numeric Rating Scale, time to return of intestinal function, time to mobilization, inflammatory response, incidence of postoperative nausea and vomiting, length of hospital stay and postoperative morbidity as assessed with the Clavien-Dindo classification.Recognizing the importance of a multimodal approach for perioperative pain management, we aim to investigate whether a transversus abdominis plane block delivers superior pain control in comparison to perioperative intravenous lidocaine and patient-controlled intravenous analgesia with morphine alone.EudraCT Identifier: 2014-001499-73; 31 July 2014.
Project description:BACKGROUND:Quadratus lumborum block (QLB) is increasingly gaining popularity as a novel abdominal truncal block in abdominal surgery; however, the mechanism of QLB is not yet thoroughly illustrated. The focus of our study is transmuscular QLB (TMQLB), as the latest anatomical evidence shows that anesthetics spread into the thoracic paravertebral space to exert an analgesic effect. Therefore, we designed this study to compare TMQLB with thoracic paravertebral block (TPVB) in laparoscopic renal surgery in the hope of providing clinical evidence on the analgesic mechanism of TMQLB and its application in laparoscopic renal surgery. METHODS:This trial is a prospective, randomized, single-center, open-label, parallel, three-arm, non-inferiority trial. We intend to include 120 participants undergoing laparoscopic nephrectomy and before surgery they will be randomized into three groups for postoperative pain control: TMQLB experimental group 1 (0.4?ml/kg body weight 0.5% ropivacaine), TMQLB experimental group 2 (0.6?ml/kg body weight 0.5% ropivacaine) or TPVB control group (0.4?ml/kg body weight 0.5% ropivacaine at vertebra T10). Patients will be excluded if they have allergy to anesthetics, infection at the injection site, are on coagulopathy or anticoagulants, on analgesics for chronic illness, have history of substance abuse or have a barrier to communication. Morphine is given in boluses of 1.5~2?mg by intravenous patient-controlled analgesia (IPCA) in the first 48?h after surgery. The primary outcome is the difference between TMQLB group 1 and the TPVB group in the mean visual analogue scale (VAS) pain score in the first 24?h after surgery. Secondary outcomes are the difference between TMQLB group 2 and the TPVB group in the mean VAS score in the first 24?h after surgery, cumulative morphine consumption, long-term pain control, dermatomal distribution of sensory loss, nausea score, pruritus score, ambulation time, time till recovery of bowel movement, quality of recovery, postoperative length of hospital stay and patient satisfaction with anesthesia. Safety data on procedure-related complications will also be summarized. DISCUSSION:This will the first randomized controlled trial to compare TMQLB with TPVB for analgesia in laparoscopic surgery. This trial aims to provide important clinical evidence to elaborate on the analgesic mechanism of TMQLB. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03414281 . Registered on 9 January 2018.
Project description:Background:The ultrasound (US)-guided erector spinae plane (ESP) block and oblique subcostal transversus abdominis plane (OSTAP) block are used to decrease postoperative pain and subsequently opioids consumption. Aim:The aim was to test the hypothesis that US-guided ESP blocks can produce more reduction in opioid usage during the first 24 h after laparoscopic cholecystectomy when compared to OSTAP block. Settings and Design:Seventy adult patients (20-60 years old) who were planned to undergo elective laparoscopic cholecystectomy were allocated in three groups in randomized controlled trial. Materials and Methods:The three groups received either port site infiltration, US-guided bilateral ESP block (ESP group), or OSTAP (OSTAP group) with bupivacaine hydrochloride 0.25%. Statistical Analysis:Postoperative 24 h Morphine consumption, visual analogue scale (VAS), the intraoperative fentanyl (?g) and equivalent morphine dose in the recovery unit were recorded and analyzed using one-way analysis of variance. Results:The mean 24-h morphine consumption was statistically significant between groups (P < 0.001), but it was insignificant between ESP and OSTAP (P = 0.173). Median (range) and interquartile range of intraoperatively consumed fentanyl showed significance between the three groups (P < 0.001). There was insignificance between ESP block Group II and OSTAP block Group III (P = 0.95) by post hoc analysis. The mean values of VAS at both rest and movement of the control group were significantly higher than the ESP block group at 6 and 12 h postoperative. Conclusion:Bilateral US-guided ESP block was found to be as effective as bilateral US OSTAP block. There was more decrease in intraoperative rescue fentanyl, PACU morphine analgesia, 24-h morphine, and pain assessment score in both groups than the control port-site infiltration group.Clinical trial registration number: NCT03398564.
Project description:BACKGROUND:Epidural analgesia as the effective pain management for abdominal surgery has side effects such as paresthesia, hypotension, hematomas, and impaired motoric of lower limbs. The quadratus lumborum block (QLB) has potential as an abdominal truncal block, however, its analgesic efficacy has never been compared to epidural analgesia on laparoscopic nephrectomy. This prospective randomized controlled study compared the effectiveness of QLB with the epidural analgesia technique in relieving postoperative pain following transperitoneal laparoscopic nephrectomy. METHODS:Sixty-two patients underwent laparoscopic donor nephrectomy and were randomized to receive QLB (n?=?31) or continuous epidural (n?=?31). The QLB group received bilateral QLB using 0.25% bupivacaine and the epidural group received 6?ml/h of 0.25% bupivacaine for intraoperative analgesia. As postoperative analgesia, the QLB group received repeated bilateral QLB with the same dose and the epidural group received 6?ml/h of 0.125% bupivacaine for 24?h after surgery completion. The primary outcome was the 24-h cumulative morphine requirement after surgery. The secondary outcome was the postoperative pain scores. Sensory block coverage, hemodynamic changes, Bromage score, postoperative nausea-vomiting (PONV), paresthesia, and duration of urinary catheter usage were recorded and analyzed. RESULT:The 24-h cumulative morphine requirement and pain scores after surgery were comparable between the QLB and epidural groups. The coverage of QLB was extended from T9 to L2 and the continuous epidural block was extended from T8 to L3 dermatomes. The mean arterial pressure (MAP) measured at 24?h after surgery was lower in the epidural group (p?=?0.001). Bromage score, incidence of PONV, and paresthesia were not significantly different between the two groups. Duration of urinary catheter usage was shorter (p?<?0.001) in the QLB group. CONCLUSION:The repeated QLB had a similar 24-h cumulative morphine requirement, comparable postoperative pain scores and sensory blockade, higher postoperative MAP, a similar degree of motoric block, no difference in the incidence of PONV and paresthesia, and shorter urinary catheter usage, compared to the continuous epidural analgesia following transperitoneal laparoscopic nephrectomy. TRIAL REGISTRATION:ClinicalTrial.gov NCT03520205 retrospectively registered on May 9th 2018.
Project description:Purpose:Perioperative pain management plays a critical role in the effort to promote enhanced recovery after surgery (ERAS). Pain is also the most concern for patients after laparoscopic cholecystectomy (LC). Naldebain (extended-release dinalbuphine sebacate, DS) is an oil-based formulation for intramuscular injection that has been designed for extended release and can be used for preoperative analgesia over a 7-day period. This study was aimed to compare the efficacy of DS injection with that of regular postoperative morphine administered when necessary for the management of post-laparoscopic cholecystectomy pain. Patients and Methods:Forty-four patients scheduled for elective laparoscopic cholecystectomy were included in this prospective study. The patients were allocated randomly into two groups, with equal numbers receiving preoperative DS versus post-operative morphine. A total of 21 and 22 patients completed the study within the preoperative DS and post-operative morphine group, respectively. Results:There were no statistically significant differences between two treatment groups with respect to length of surgery, anesthetics used during operation, or the average visual analog scale pain score in the post-operative anesthesia care unit (PACU), and at 4, 24, 48, and 72 hours post-procedure. Morphine was required only during the first postoperative day among those in the DS group. Safety was comparable in both DS and morphine groups. Conclusion:A single preoperative dose of DS provides sufficient analgesia along with a manageable safety profile and no interference with surgical anesthetics when compared to control cases that underwent surgery without preoperative DS treatment. This pilot study suggests that preoperative administration of DS is safe and may decrease the need for postoperative opioid use after laparoscopic cholecystectomy. Registration:ClinicalTrials.gov Identifier: NCT03713216.
Project description:Despite rapid advancements in laparoscopic surgical devices and techniques, pain remains a significant issue. We examined the efficacy of preemptive transversus abdominis plane (TAP) block for acute postoperative pain in patients undergoing laparoscopic colorectal cancer surgery. We retrospectively analyzed 153 patients who underwent laparoscopic colorectal cancer surgery with or without TAP block; among them, 142 were allocated to the TAP or non-TAP group. We performed between-group comparisons of demographic, clinical, and anesthetic data and pain scores at a postoperative anesthesia care unit (PACU) and at postoperative days 1, 3, and 5. There were no significant between-group differences in demographic and clinical characteristics. The mean arterial pressure, heart rate, and minimum alveolar concentration (MAC) were significantly lower in the TAP group at the start and end of surgery. The post-extubation bispectral index was significantly higher in the TAP group. There were no significant between-group differences in the pain scores and opioid consumption at the PACU or at postoperative days 1, 3, and 5, or in the time to pass flatus, the hospital stay length, and postoperative complications. Preemptive TAP block showed an intraoperative, but not postoperative, analgesic effect, characterized by a low mean arterial pressure, heart rate, and MAC.
Project description:BACKGROUND:As a part of multimodal analgesia for laparoscopic cholecystectomy, both intraoperative lidocaine and esmolol facilitate postoperative analgesia. Our objective was to compare these two emerging strategies that challenge the use of intraoperative opioids. We aimed to assess if intraoperative esmolol infusion is not inferior to lidocaine infusion for opioid consumption after laparoscopic cholecystectomy. METHODS:In this prospective, randomized, double-blind, non-inferiority clinical trial, 90 female patients scheduled for elective laparoscopic cholecystectomy received either intravenous (IV) lidocaine bolus 1.5?mg/kg at induction followed by an infusion (1.5?mg/ kg/h) or IV bolus of esmolol 0.5?mg/kg at induction followed by an infusion (5-15??g/kg/min) till the end of surgery. Remaining aspect of anesthesia followed a standard protocol apart from no intraoperative opioid supplementation. Postoperatively, patients received either morphine or tramadol IV to maintain visual analogue scale (VAS) scores ?3. The primary outcome was opioid consumption (in morphine equivalents) during the first 24 postoperative hours. Pain and sedation scores, time to first perception of pain and void, and occurrence of nausea/vomiting were secondary outcomes measured up to 24?h postoperatively. RESULTS:Two patients in each group were excluded from the analysis. The postoperative median (IQR) morphine equivalent consumption in patients receiving esmolol was 1 (0-1.5) mg compared to 1.5 (1-2) mg in lidocaine group (p?=?0.27). The median pain scores at various time points were similar between the two groups (p?>?0.05). More patients receiving lidocaine were sedated in the post-anesthesia care unit (PACU) than those receiving esmolol (p?<?0.05); however, no difference was detected later. CONCLUSION:Infusion of esmolol is not inferior to lidocaine in terms of opioid requirement and pain severity in the first 24?h after surgery. Patients receiving lidocaine were more sedated during their stay in PACU than those receiving esmolol. TRIAL REGISTRATION:ClinicalTrials.gov - NCT02327923. Date of registration: December 31, 2014.
Project description:BACKGROUND:Iliac crest bone graft (ICBG) harvesting is associated with significant perioperative pain and opioid consumption. This randomized controlled trial sought to determine if the transversalis fascia plane (TFP) block provides effective analgesia for anterior ICBG harvesting. METHODS:Fifty patients undergoing wrist fusion surgery with anterior ICBG harvesting were randomized to receive a TFP block with either 20 ml of 0.5% ropivacaine or 5% dextrose. Patients additionally received a brachial plexus block for primary surgical-site anesthesia and either a general or spinal anesthetic depending on patient preference. Primary outcomes of interest were perioperative opioid consumption (measured as intravenous morphine equivalents [IME]), pain intensity at the ICBG harvest site for up to 48 h postoperatively, and the incidence of persistent postoperative pain at 6 and 12 months after surgery. RESULTS:The TFP group used less opioid in the post-anesthetic care unit (PACU) (median 0 vs. 2.5 mg IME, P = 0.01) and in the first 8 h following PACU discharge (median 2.5 vs. 13.0 mg IME, P = 0.02). The patients who received a TFP block also had lower pain scores in PACU (median 0 vs. 4.0 out of 10, P < 0.001). Although opioid consumption and pain scores were lower in the TFP group at later timepoints, this difference was not statistically significant. Persistent pain at the ICBG site was reported in only 4.3% and 6.5% of all patients at 6 and 12 months, respectively. CONCLUSIONS:The TFP block provides effective early analgesia for anterior ICBG harvesting. The incidence of persistent postoperative pain was low.
Project description:Background:Postoperative pain management is important for the early recovery of the living donor patient. Patient-controlled opioid analgesia, epidural analgesia, or a combination of both is the preferred pain management after abdominal surgery although these approaches have serious side effects. The transversus abdominis plane (TAP) block has been increasingly used for postoperative pain management and the addition of dexamethasone to local anesthetic can prolong the duration of action. Objectives:This study evaluated the efficacy of ultrasound-guided three-quadrant TAP block analgesia with the addition of dexamethasone, compared to the continuous epidural analgesia in postoperative cumulative opioid consumption and pain scale in the first 24 hours following transperitoneal laparoscopic living donor nephrectomy. Methods:A prospective randomized control study was conducted on 50 patients with ASA I-II, 18 - 65 years old, BMI 18 - 30, and undergoing transperitoneal laparoscopic donor nephrectomy under general anesthesia. The patients were randomly assigned into either a three-quadrant TAP block group (n = 25) with 20 mL of 0.25% bupivacaine plus dexamethasone 8 mg or a continuous epidural group (n = 25) using 0.125% bupivacaine postoperatively. The morphine consumption and the numerical rating scale (NRS) at rest and movement were evaluated at 2, 6, 12, and 24 hours postoperatively. The postoperative first-time mobilization and duration of urinary catheter usage were recorded. Results:Patients demographic characteristics were similar in the two groups. During 24 hours after the surgery, cumulative morphine consumption (P = 0.232), the NRS at rest and movement (P > 0.05), and the first-time mobilization (P = 0.075) were not significantly different between the groups, except that the NRS during movement at 12 hours was significantly lower in the TAP block group (P = 0.004). The duration of urinary catheterization was significantly longer as a side effect in the continuous epidural group (P < 0.001). Conclusions:The three-quadrant TAP block with the addition of dexamethasone showed comparable analgesic effects as the continuous epidural analgesia in cumulative opioid consumption and pain scale in the first 24 hours following transperitoneal laparoscopic donor nephrectomy.
Project description:Knee arthroplasty leads to postoperative pain. This study compares analgesia and postoperative bleeding achieved by intrathecal morphine with a continuous femoral plus single-shot sciatic nerve block.A randomized non-blinded clinical trial enrolled patients aged over 18 years old, ASA I to III who underwent total knee arthroplasty. All patients underwent spinal anesthesia with isobaric bupivacaine, 20 mg. One group received 100 mcg of intrathecal morphine (M group), and the other received a femoral nerve block by continuous infusion plus a "single shot" block of the sciatic nerve at the end of the surgery (FI group). Pain score from verbal numeric rating scale (VNRS) and morphine consumption during the first 72 h, as well as motor blockade, adverse effects, and postoperative bleeding were recorded. Analysis of variance of repeated measures with Bonferroni post-test, t-test and Fisher exact test were used for statistical analysis.Thirty nine patients completed the study (M?=?20; FI?=?19 patients) and were similar except for higher age in the FI group. Motor blockade as well as movement pain during postanesthesia care unit (PACU) staying were not different between the groups, but movement pain was significantly lower in FI group after 24 h. Postoperative bleeding (ml) was lower in FI group.Continuous femoral nerve block combined with sciatic nerve block provides effective for postoperative analgesia in patients undergoing total knee arthroplasty, with lower pain scores after 24 h and a lower incidence of adverse effects and bleeding compared to intrathecal morphine.Retrospectively registered on https://clinicaltrials.gov/ under identifier NCT02882152 , 23rd December, 2016.