Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty

December 12, 2019 updated by: samer jabbour, St Joseph University, Beirut, Lebanon

Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty: A Randomized Controlled Study

The original concept of a quadratus lumborum block (QLB) indicated for analgesia after abdominal surgery was first described by Blanco in 2007. Also referred to as a posterior transversus abdominis plane (TAP) block, the QLB consists in deposition of local anesthetic on either the posterior or the anterolateral border of the quadratus lumborum muscle. TAP blocks have already been proved effective in urologic, abdominal, and gynecologic procedures by blocking the sensory nerve supply to the anterior abdominal wall thus reducing the amount of postoperative analgesic medication. The main advantages of QLB compared to the TAP block is a wider sensory block area and a longer duration of analgesia. This is due to the extension of local anesthetic agents beyond the TAP plane to the thoracic paravertebral space(4).

Previous reports have shown that QLB is effective in providing pain relief after various abdominal operations. However, there are no published reports on QLB for postoperative pain after abdominoplasty. This prospective, randomized, double-blinded, controlled study aims to evaluate the analgesic efficacy, opioids consumption and quality of recovery of QLB in patients undergoing abdominoplasty. Patients scheduled to have abdominoplasty will be randomized to receive bilateral QLB with either ropivacaine 0.2% or normal saline. Post-operative cumulative analgesic medication consumption, pain severity at rest and on movement, as well as quality of recovery will be evaluated and compared in both groups.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Aschrafieh
      • Beirut, Aschrafieh, Lebanon, 00961
        • Hotel Dieu de France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Standard abdominoplasty procedure
  2. Written informed consent
  3. Age ≥ 18 years
  4. Female

Exclusion Criteria:

  1. Patient's refusal
  2. Allergies to any study medication
  3. Inability to comprehend or participate in scoring scales
  4. Deformations that could possibly affect the spread of the local anesthetic in the quadratus lumborum muscle plane
  5. Quadratus lumborum muscle plane not seen in ultrasound examination
  6. Coagulopathy or on anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: QLB group

Patients will receive at the beginning of the surgery 0.2 ml/kg of 0.2% ropivacaine bilaterally.

Procedure: Quadratus Lumborum Block type II, local anesthetic injection on the posterior border of the quadratus lumborum muscle Drug: Ropivacaine, 0.2 ml/kg of 0.2% ropivacaine

0,2ml/kg of 0,2% ropivacaine
PLACEBO_COMPARATOR: Control group

Patients will receive at the beginning of the surgery 0.2 ml/kg of 0.9% normal saline bilaterally.

Procedure: Quadratus Lumborum Block type II, local anesthetic injection on the posterior border of the quadratus lumborum muscle Drug: Normal saline, 0.2 ml/kg of 0.9 % normal saline

0,2ml/kg of 0.9% normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative morphine consumption
Time Frame: up to 48 hour
Cumulative morphine consumption in mg while in the PACU and tramadol dose till 48 hour post operatively.
up to 48 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first tramadol dose
Time Frame: up to 48 hour
Time to first tramadol dose: time from the discharge to the surgical ward to the first postoperative subcutaneous tramadol dose requested by the patient.
up to 48 hour
Postoperative pain severity
Time Frame: up to 48 hour
Postoperative pain severity in Numerical Rating Scale at rest in the first 48 hour after surgery. Ranging from 0 for no pain to 10 for worst pain imaginable. All patients will be assessed postoperatively by a blinded investigator: at 2, 4, 6, 12, 24, 36, and 48 hour postoperatively.
up to 48 hour
Postoperative dynamic pain severity
Time Frame: up to 48 hour
Postoperative dynamic pain severity (walking, coughing, deep breathing) in Numerical Rating Scale in the first 48 hour after surgery. Ranging from 0 for no pain to 10 for worst pain imaginable. All patients will be assessed postoperatively by a blinded investigator: at 2, 4, 6, 12, 24, 36, and 48 hour postoperatively.
up to 48 hour
Nausea or vomiting
Time Frame: up to 48 hour

Nausea or vomiting up to 48h post operatively (2, 4, 6, 12, 24, 36, and 48 hour postoperatively) using the following four grades scale:

0 = No nausea; 1 = Mild nausea; 2 = Moderate nausea; 3 = Severe nausea or vomiting

up to 48 hour
Sedation level
Time Frame: up to 48 hour
Sedation level up to 48 hour post operatively using the following Ramsay score.
up to 48 hour
Quality of recovery
Time Frame: up to 48 hour
Quality of recovery using the self-assessment quality of recovery (QoR) scale to assess the patient's recovery quality
up to 48 hour
Time to first walk
Time Frame: up to 48 hour
Time to first walk
up to 48 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (ESTIMATE)

October 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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