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NCT Number: NCT02932930

Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hotel Dieu De France

Beirut, Aschrafieh, 00961, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QLB bloc

Procedure

0.2% ropivacaine

Drug

0,2ml/kg of 0,2% ropivacaine

0.9% normal saline

Drug

0,2ml/kg of 0.9% normal saline

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. Sedation level

    Time frame: up to 48 hour

    Sedation level up to 48 hour post operatively using the following Ramsay score.

  6. 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

  7. Time to first walk

    Time frame: up to 48 hour

    Time to first walk

Sponsors and collaborators

Lead sponsor

St Joseph University, Beirut, Lebanon

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 13, 2016
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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