Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Procedure: QLB bloc
* Drug: 0.2% Ropivacaine
* Drug: 0.9% normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Standard abdominoplasty procedure Written informed consent Age ≥ 18 years Female Exclusion Criteria: Patient's refusal Allergies to any study medication Inability to comprehend or participate in scoring scales Deformations that could possibly affect the spread of the local anesthetic in the quadratus lumborum muscle plane Quadratus lumborum muscle plane not seen in ultrasound examination Coagulopathy or on anticoagulants
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: QLB group<br>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 | Procedure: QLB bloc<br> <br> Drug: 0.2% Ropivacaine<br>* 0,2ml/kg of 0,2% ropivacaine<br>|
| Placebo Comparator: Control group<br>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 | Procedure: QLB bloc<br> <br> Drug: 0.9% normal saline<br>* 0,2ml/kg of 0.9% normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative morphine consumption | 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 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 | 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 | 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 | 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 | Sedation level up to 48 hour post operatively using the following Ramsay score. | up to 48 hour | 
| Quality of recovery | 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 to first walk | up to 48 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QLB, Abdominoplasty, Quadratus lumborum block