NCT02932930

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

2.7 years

First QC Date

October 10, 2016

Last Update Submit

December 12, 2019

Conditions

Keywords

QLBAbdominoplastyQuadratus lumborum block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Time to first tramadol dose

    up to 48 hour

  • Postoperative pain severity

    up to 48 hour

  • Postoperative dynamic pain severity

    up to 48 hour

  • Nausea or vomiting

    up to 48 hour

  • Sedation level

    up to 48 hour

  • +2 more secondary outcomes

Study Arms (2)

QLB group

ACTIVE COMPARATOR

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 blocDrug: 0.2% Ropivacaine

Control group

PLACEBO COMPARATOR

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 blocDrug: 0.9% normal saline

Interventions

QLB blocPROCEDURE
Control groupQLB group

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

QLB group

0,2ml/kg of 0.9% normal saline

Control group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Standard abdominoplasty procedure
  • Written informed consent
  • Age ≥ 18 years
  • Female

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu De France

Beirut, Aschrafieh, 00961, Lebanon

Location

Related Publications (7)

  • 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.

    PMID: 27315184BACKGROUND
  • 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.

    PMID: 27513972BACKGROUND
  • 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.

    PMID: 21788846BACKGROUND
  • 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.

    PMID: 26735154BACKGROUND
  • 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.

    PMID: 26174113BACKGROUND
  • 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.

    PMID: 26225500BACKGROUND
  • 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.

    PMID: 25642956BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

RopivacaineSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 13, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2019

Study Completion

August 1, 2019

Last Updated

December 13, 2019

Record last verified: 2019-12

Locations