Quadratus Lumborum Block Versus Transversus Abdominis Block

NCT ID: NCT04367233

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2025-09-01

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.

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% ropivacaine 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% ropivacaine 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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo group

General anesthesia with fentanyl, propofol and remifentanyl

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: OTHER

General anesthesia with fentanyl, propofol and remifentanil.

Transverse block group

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.

Group Type: EXPERIMENTAL

Transverse abdominal block

Intervention Type: OTHER

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

Quadratus lumborum group

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.

Group Type: EXPERIMENTAL

Quadratus lumborum block

Intervention Type: 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

Interventions

General anesthesia

General anesthesia with fentanyl, propofol and remifentanil.

Intervention Type: OTHER

Transverse abdominal block

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

Intervention Type: OTHER

Quadratus lumborum block

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Scheduled to gynecological video laparoscopy.

Exclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joaquim Edson Vieira

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

São Paulo, , Brazil

Countries

Brazil

Central Contacts

sebastião ernesto

Role: CONTACT

sebasernesto@gmail.com

12991457764

Facility Contacts

joaquim vieira, MD

Role: primary

joaquimve@usp.br

55-11-30618716

Sebastião Silva Filho, Physician

Role: backup

sebasernesto@gmail.com

12991457764

References

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.

Reference Type: BACKGROUND

PMID: 19275847 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30688787 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30975950 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29723644 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31649394 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20221641 (View on PubMed)

Other Identifiers

CAAE 28763119.0.0000.5448

Identifier Type: -

Identifier Source: org_study_id