Quadratus Lumborum Block Versus Transversus Abdominis Block

NCT04367233 | Unknown

• 1 other identifier: CAAE 28763119.0.0000.5448
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Morphine consumption

  Consumption of morphine in the postoperative period,during hospital stay

  12 hours

• Codeine consumption

  Consumption of codeine during the 48 hours following the surgery

  Two days

Secondary Outcomes (1)

• Postoperative pain

  Two days

Study Arms (3)

Placebo group

ACTIVE COMPARATOR

General anesthesia with fentanyl, propofol and remifentanyl

Other: General anesthesia

Transverse block group

EXPERIMENTAL

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

Other: Transverse abdominal block

Quadratus lumborum group

EXPERIMENTAL

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

Other: Quadratus lumborum block

Interventions

General anesthesia OTHER

General anesthesia with fentanyl, propofol and remifentanil.

Placebo group

Transverse abdominal block OTHER

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

Transverse block group

Quadratus lumborum block OTHER

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

Quadratus lumborum group

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to gynecological video laparoscopy.

You may not qualify if:

• Allergy to any component of the study protocol, coagulopathies.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 01246-903, Brazil

Location

Related Publications (6)

• Kelley WE Jr. The evolution of laparoscopy and the revolution in surgery in the decade of the 1990s. JSLS. 2008 Oct-Dec;12(4):351-7. No abstract available.

  PMID: 19275847 BACKGROUND

• Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.

  PMID: 30688787 BACKGROUND

• Suner ZC, Kalayci D, Sen O, Kaya M, Unver S, Oguz G. Postoperative analgesia after total abdominal hysterectomy: Is the transversus abdominis plane block effective? Niger J Clin Pract. 2019 Apr;22(4):478-484. doi: 10.4103/njcp.njcp_61_15.

  PMID: 30975950 BACKGROUND

• Bacal V, Rana U, McIsaac DI, Chen I. Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):40-52. doi: 10.1016/j.jmig.2018.04.020. Epub 2018 Apr 30.

  PMID: 29723644 BACKGROUND

• Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth. 2019 Oct;63(10):820-826. doi: 10.4103/ija.IJA_61_19. Epub 2019 Oct 10.

  PMID: 31649394 BACKGROUND

• Ferreira KA, Teixeira MJ, Mendonza TR, Cleeland CS. Validation of brief pain inventory to Brazilian patients with pain. Support Care Cancer. 2011 Apr;19(4):505-11. doi: 10.1007/s00520-010-0844-7. Epub 2010 Mar 10.

  PMID: 20221641 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

sebastião ernesto

CONTACT

12991457764; sebasernesto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Prospective, controlled, randomized and double blinded.

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 29, 2020
• Study Start: June 20, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

BR (1)