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Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
QLB bloc
0.2% Ropivacaine
0.9% normal saline
Sponsored by
St Joseph University, Beirut, Lebanon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring QLB, Abdominoplasty, Quadratus lumborum block

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hotel Dieu De France

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

QLB group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cumulative morphine consumption
Cumulative morphine consumption in mg while in the PACU and tramadol dose till 48 hour post operatively.

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2016
Last Updated
December 12, 2019
Sponsor
St Joseph University, Beirut, Lebanon
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1. Study Identification

Unique Protocol Identification Number
NCT02932930
Brief Title
Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty
Official Title
Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Joseph University, Beirut, Lebanon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
QLB, Abdominoplasty, Quadratus lumborum block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QLB group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
QLB bloc
Intervention Type
Drug
Intervention Name(s)
0.2% Ropivacaine
Intervention Description
0,2ml/kg of 0,2% ropivacaine
Intervention Type
Drug
Intervention Name(s)
0.9% normal saline
Intervention Description
0,2ml/kg of 0.9% normal saline
Primary Outcome Measure Information:
Title
Cumulative morphine consumption
Description
Cumulative morphine consumption in mg while in the PACU and tramadol dose till 48 hour post operatively.
Time Frame
up to 48 hour
Secondary Outcome Measure Information:
Title
Time to first tramadol dose
Description
Time to first tramadol dose: time from the discharge to the surgical ward to the first postoperative subcutaneous tramadol dose requested by the patient.
Time Frame
up to 48 hour
Title
Postoperative pain severity
Description
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.
Time Frame
up to 48 hour
Title
Postoperative dynamic pain severity
Description
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.
Time Frame
up to 48 hour
Title
Nausea or vomiting
Description
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
Time Frame
up to 48 hour
Title
Sedation level
Description
Sedation level up to 48 hour post operatively using the following Ramsay score.
Time Frame
up to 48 hour
Title
Quality of recovery
Description
Quality of recovery using the self-assessment quality of recovery (QoR) scale to assess the patient's recovery quality
Time Frame
up to 48 hour
Title
Time to first walk
Description
Time to first walk
Time Frame
up to 48 hour

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hotel Dieu De France
City
Beirut
State/Province
Aschrafieh
ZIP/Postal Code
00961
Country
Lebanon

12. IPD Sharing Statement

Citations:
PubMed Identifier
27315184
Citation
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.
Results Reference
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PubMed Identifier
27513972
Citation
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.
Results Reference
background
PubMed Identifier
21788846
Citation
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.
Results Reference
background
PubMed Identifier
26735154
Citation
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.
Results Reference
background
PubMed Identifier
26174113
Citation
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.
Results Reference
background
PubMed Identifier
26225500
Citation
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.
Results Reference
background
PubMed Identifier
25642956
Citation
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.
Results Reference
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Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty

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