search
Back to results

Quadratus Lumborum Block Versus Transversus Abdominis Block

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
General anesthesia
Transverse abdominal block
Quadratus lumborum block
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled to gynecological video laparoscopy.

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Placebo group

Transverse block group

Quadratus lumborum group

Arm Description

General anesthesia with fentanyl, propofol and remifentanyl

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.

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.

Outcomes

Primary Outcome Measures

Morphine consumption
Consumption of morphine in the postoperative period,during hospital stay
Codeine consumption
Consumption of codeine during the 48 hours following the surgery

Secondary Outcome Measures

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)

Full Information

First Posted
April 21, 2020
Last Updated
April 25, 2023
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04367233
Brief Title
Quadratus Lumborum Block Versus Transversus Abdominis Block
Official Title
Quadratus Lumborum Block Versus Transversus Abdominis Block . Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, controlled, randomized and double blinded.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Active Comparator
Arm Description
General anesthesia with fentanyl, propofol and remifentanyl
Arm Title
Transverse block group
Arm Type
Experimental
Arm Description
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.
Arm Title
Quadratus lumborum group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
General anesthesia
Intervention Description
General anesthesia with fentanyl, propofol and remifentanil.
Intervention Type
Other
Intervention Name(s)
Transverse abdominal block
Intervention Description
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
Intervention Name(s)
Quadratus lumborum block
Intervention Description
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
Primary Outcome Measure Information:
Title
Morphine consumption
Description
Consumption of morphine in the postoperative period,during hospital stay
Time Frame
12 hours
Title
Codeine consumption
Description
Consumption of codeine during the 48 hours following the surgery
Time Frame
Two days
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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)
Time Frame
Two days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled to gynecological video laparoscopy. Exclusion Criteria: Allergy to any component of the study protocol, coagulopathies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sebastião ernesto
Phone
12991457764
Email
sebasernesto@gmail.com
Facility Information:
Facility Name
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
City
São Paulo
ZIP/Postal Code
01246-903
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
joaquim vieira, MD
Phone
55-11-30618716
Email
joaquimve@usp.br
First Name & Middle Initial & Last Name & Degree
Sebastião Silva Filho, Physician
Phone
12991457764
Email
sebasernesto@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19275847
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.
Results Reference
background
PubMed Identifier
30688787
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.
Results Reference
background
PubMed Identifier
30975950
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.
Results Reference
background
PubMed Identifier
29723644
Citation
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.
Results Reference
background
PubMed Identifier
31649394
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.
Results Reference
background
PubMed Identifier
20221641
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.
Results Reference
background

Learn more about this trial

Quadratus Lumborum Block Versus Transversus Abdominis Block

We'll reach out to this number within 24 hrs