- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02932930
Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aschrafieh
-
Beirut, Aschrafieh, Lebanon, 00961
- Hotel Dieu de France
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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
Publications and helpful links
General Publications
- El-Boghdadly K, Elsharkawy H, Short A, Chin KJ. Quadratus Lumborum Block Nomenclature and Anatomical Considerations. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):548-9. doi: 10.1097/AAP.0000000000000411. No abstract available.
- Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.
- Sforza M, Andjelkov K, Zaccheddu R, Nagi H, Colic M. Transversus abdominis plane block anesthesia in abdominoplasties. Plast Reconstr Surg. 2011 Aug;128(2):529-535. doi: 10.1097/PRS.0b013e31821e6f51.
- Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
- Baidya DK, Maitra S, Arora MK, Agarwal A. Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty. J Clin Anesth. 2015 Dec;27(8):694-6. doi: 10.1016/j.jclinane.2015.05.006. Epub 2015 Jul 11. No abstract available.
- Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
- Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USJ-02
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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