Quadratus Lumborum Block Versus Transversus Abdominis Block

Postoperative Pain Clinical Trial

Official title:

Quadratus Lumborum Block Versus Transversus Abdominis Block . Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04367233
• Other study ID #: CAAE 28763119.0.0000.5448
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2023
• Source: University of Sao Paulo General Hospital
• Contact: sebastião ernesto
• Phone: 12991457764
• Email: sebasernesto[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• Scheduled to gynecological video laparoscopy.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Consumption of morphine in the postoperative period,during hospital stay	12 hours
Primary	Codeine consumption	Consumption of codeine during the 48 hours following the surgery	Two days
Secondary	Postoperative pain	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)	Two days