Quadratus Lumborum Block Versus Transversus Abdominis Block

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04367233
Collaborator
(none)
75
1
3
5.3
14.2

Study Details

Study Description

Brief Summary

The advent of laparotomy replacement by minimally invasive techniques brought the obvious benefit of postoperative pain reduction. The application of transversus abdominis block has already demonstrated to reduce postoperative pain in laparoscopic hysterectomy. The comparison between it and quadratus lumborum block in cesarean sections showed that the latter was superior in relation to postoperative analgesia. The aim of this trial is to compare postoperative analgesia in patients receiving one or the other of these regional anesthesia techniques to prevent postoperative pain in gynecological laparoscopic surgeries. The recruited sample will be randomly distributed in three groups to receive placebo, transverse abdominal plan block or quadratus lumborum block, in a covert way for the patients and team. The primary outcome evaluated will be the postoperative consumption of opioid and the secondary outcome will be the evaluation of postoperative pain scores.

Condition or Disease Intervention/Treatment Phase
  • Other: General anesthesia
  • Other: Transverse abdominal block
  • Other: Quadratus lumborum block
N/A

Detailed Description

: the sample will be divided into three groups and all participants will receive general anesthesia. Patients in the placebo group (PG) will be referred to the post-anesthesia recovery room after extubation and adequate hemodynamic and respiratory recovery. Patients in the tap block group (TBG) will receive 0.2 ml of 0.25% levobupivacaine between the transverse and oblique internal muscles guided by ultrasound (US), on one side and after the other (the same dose), after the end of surgery. Patients in the quadratus lumborum group (LQG) will receive 0.2 ml/kg of 0.25% levobupivacaine inside the middle layer of the thoracolumbar fascia guided by US, on one side and after the other (the same dose), after the end of the surgery. In all participants, the monitoring will include cardioscope, oximetry, non-invasive blood pressure and monitor of hypnoses level. After peripheral venous puncture, antibiotic prophylaxis with 2g cefazolin, and pre-anesthetic medication with midazolam 0.05 mg/kg. After 5 min pre-oxygenation, the patients will receive venous anesthetic induction with 2% lidocaine 1mg/kg without vasoconstrictor; fentanyl 4 µ/kg; propofol 2 mg/kg, or even adequate hypnosis guided by proper monitor; cisatracurium 0.15mg/kg, with tracheal intubation and mechanical ventilation after anesthetic plan confirmed with proper monitor and adequate muscle relaxation. Anesthesia will be maintained with propofol in continuous infusion guided by hypnoses monitor and remifentanil in continuous infusion between 0.1 and 0.5 µg/kg/min, according to patient need. All study participants will receive ondansetron 8 mg, dipyrone 2 g, ketoprofen 100 mg, dexamethasone 10 mg and morphine 3 mg. At the end of the surgery, after partial recovery from neuromuscular blockade, patients will receive atropine 0.01 mg/kg and neostigmine: 0.02mg/kg before tracheal extubation.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, controlled, randomized and double blinded.Prospective, controlled, randomized and double blinded.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
A professional who will not participate in other stages of the study will conduct the drawing and envelopes preparation. Masking: at the end of the surgery, the anesthesiologist will perform the blocking corresponding to the patient's group and will not participate in other stages of the study. A professional who does not know the group to which each patient belongs will perform the collection and analysis of the endpoint variables.
Primary Purpose:
Prevention
Official Title:
Quadratus Lumborum Block Versus Transversus Abdominis Block . Randomized Clinical Trial.
Actual Study Start Date :
Aug 4, 2021
Actual Primary Completion Date :
Jan 12, 2022
Actual Study Completion Date :
Jan 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Placebo group

General anesthesia with fentanyl, propofol and remifentanyl

Other: General anesthesia
General anesthesia with fentanyl, propofol and remifentanil.

Experimental: Transverse block group

At the end of general anesthesia with fentanyl, propofol and remifentanil, the patient will receive transverse plan block, with levobupivacaine 0,25% 0,2 ml/kg.

Other: Transverse abdominal block
Transverse abdominal block with levobupivacaine 0,25% 0,2 ml/kg at the end of general anesthesia with fentanyl, propofol and remifentanil

Experimental: Quadratus lumborum group

At the end of general anesthesia with fentanyl, propofol and remifentanil, the patient will receive quadratus lumborum block with levobupivacaine 0,25% 0,2 ml/kg.

Other: Quadratus lumborum block
At the end of general anesthesia with fentanyl, propofol and remifentanil, patients will receive quadratus lumborum block with levobupivacaine 0,25% 0,2 ml/kg

Outcome Measures

Primary Outcome Measures

  1. Morphine consumption [12 hours]

    Consumption of morphine in the postoperative period,during hospital stay

  2. Codeine consumption [Two days]

    Consumption of codeine during the 48 hours following the surgery

Secondary Outcome Measures

  1. Postoperative pain [Two days]

    Pain scores on awaking, 6 hours after, and during the first 2 postoperative days, based on verbal pain score, ranging 0 (without pain) to 10 (worst imaginable pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Scheduled to gynecological video laparoscopy.
Exclusion Criteria:
  • Allergy to any component of the study protocol, coagulopathies.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo São Paulo Brazil 01246-903

Sponsors and Collaborators

  • University of Sao Paulo General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Joaquim Edson Vieira, Associate professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT04367233
Other Study ID Numbers:
  • CAAE 28763119.0.0000.5448
First Posted:
Apr 29, 2020
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2022