Dataset Information

Laparoscopically guided transversus abdominis plane block versus local wound analgesia in laparoscopic surgery for peritoneal endometriosis: study protocol for a prospective randomized controlled double-blinded LTAP-trial.

ABSTRACT:

Background

Ultrasound-guided transversus abdominis plane block (TAP) performed by anesthesiologist has been shown to be an effective and safe analgesia method in abdominal surgery, reducing postoperative opioid consumption. Recently, there has been growing interest to insert TAP under laparoscopic vision (LTAP) by surgeon. LTAP has been used in laparoscopic gastrointestinal surgery, but studies on LTAP in gynecologic laparoscopic surgery are sparse and inconsistent. The purpose of this study is to compare the efficacy of LTAP and local wound analgesia in laparoscopic surgery due to suspected or diagnosed superficial peritoneal endometriosis.

Methods

The LTAP-trial is a prospective randomized controlled double-blinded study comparing the efficacy and safety of LTAP with local wound analgesia in laparoscopic endometriosis surgery. Patients are randomized to receive LTAP with levobupivacaine and wound infiltration with placebo or wound infiltration with levobupivacaine and LTAP with placebo. The primary outcome is postoperative opioid consumption measured by patient-controlled analgesia (PCA) pump. Secondly, subjective postoperative pain up to 24 h postoperatively will be measured by Numeric Rating Scale (NRS). Additional outcome measures are factors related to recovery and length of stay in the hospital as well as a 6-month follow-up survey regarding pain (NRS) and endometriosis-related wellbeing (endometriosis-related health profile, EHP-30) after surgery. A total of 46 patients will be randomized in a proportion of 1:1.

Discussion

Patients with peritoneal endometriosis are often prone to severe postoperative pain that may prohibit their enhanced recovery after laparoscopy. Thus, there is a need for effective postoperative pain management with minimal side-effects. This study focusing on laparoscopically inserted transversus abdominis plane block may provide new insight in dealing with postoperative pain after laparoscopic endometriosis surgery as well as after other gynecologic surgery.

Trial registration

The LTAP-trial -protocol has been prospectively registered to ClinicalTrials.gov , ID: NCT04735770 . Registered on February 2021.

SUBMITTER: Terho A

PROVIDER: S-EPMC8764771 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:BackgroundThe transversus abdominis plane (TAP) block is an important non-narcotic adjunct for post-operative pain control in abdominal surgery. Surgeons can use laparoscopic guidance for TAP block placement (LTAP), however, direct comparisons to conventional ultrasound-guided TAP (UTAPs) have been lacking. The aim of this study is to determine if surgeon placed LTAPs were non-inferior to anesthesia placed UTAPs for post-operative pain control in laparoscopic colorectal surgery.MethodsThis was a prospective, randomized, patient and observer blinded parallel-arm non-inferiority trial conducted at a single tertiary academic center between 2016 and 2018 on adult patients undergoing laparoscopic colorectal surgery. Narcotic consumption and pain scores were compared for LTAP vs. UTAP for 48 h post-operatively.Results60 patients completed the trial (31 UTAP, 29 LTAP) of which 25 patients were female (15 UTAP, 10 LTAP) and the mean ages (SD) were 60.0 (13.6) and 61.5 (14.3) in the UTAP and LTAP groups, respectively. There was no significant difference in post-operative narcotic consumption between UTAP and LTAP at the time of PACU discharge (median [IQR] milligrams of morphine, 1.8 [0-4.5] UTAP vs. 0 [0-8.7] LTAP P = .32), 6 h post-operatively (5.4 [1.8-17.1] UTAP vs. 3.6 [0-12.6] LTAP P = .28), at 12 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .51), at 24 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .63), and 48 h post-operatively (39.9 [7.5-70.2] UTAP vs. 22.2 [7.5-63.8] LTAP P = .41). Patient-reported pain scores as well as pre-, intra-, and post-operative course were similar between groups. Non-inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h.ConclusionsSurgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period.Trial registryThe trial was registered at clinicaltrials.gov Identifier NCT03577912.