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Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Quadratus Lumborum block
Tranversus Abdominis plane block
Sponsored by
Corniche Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Elective caesarean sections ASA 1 to 3 Written informed consent.

Exclusion Criteria:

Patient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous patient controlled analgesia

Sites / Locations

  • Corniche Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadratus Lumborum block group

Transversus abdominis plane block group

Arm Description

Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%

Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125%

Outcomes

Primary Outcome Measures

Total morphine used in the first 48 hours after surgery
Total cumulative morphine dose in mg used in the first 48 hours after surgery

Secondary Outcome Measures

Severity of postoperative pain via visual analogue pain scale (VAS)
VAS range from 0 for no pain to 10 for worst pain imaginable
Nausea or vomiting
0 = No Nausea = Mild Nausea. = Moderate = Severe Nausea or Vomiting
Sedation score
= drowsy but responds to normal verbal communication. = asleep, but awakes with verbal communication. = asleep, awakens with mild physical stimulation. = asleep, unresponsive to mild physical stimulation.

Full Information

First Posted
July 2, 2015
Last Updated
May 22, 2016
Sponsor
Corniche Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02489851
Brief Title
Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section
Official Title
Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Post Cesarean Section Analgesia. A Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corniche Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents may produce extensive analgesia and prolonged action of the injected local anesthetic solution. Previous studies showed that both TAP block and QLB may reduce morphine requirements in the postoperative period in patients who had cesarean section under spinal anaesthesia. However there are no published reports comparing the 2 techniques. The aim of this randomised controlled, double blinded study is to compare the analgesic efficacy of QLB compared to TAP block in patients who had cesarean section under spinal anesthesia.
Detailed Description
After ethical committee approval, informed written consent will be obtained from all patients. A Sample size of 72 patients (36 per group) was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8. Consenting patients scheduled to have elective cesarean section under spinal anesthesia will be randomised to receive bilateral QLB or TAP at the end of surgery.The dose of local anaesthetic in both groups will be 0.2 ml/kg 0.125% Bupivacaine. Allocation to either group will be done using closed envelope technique. All the blocks will be performed in operation theatre after the end of cesarean section with intravenous access, ECG, BP, oxygen saturation by pulse oximetry monitoring and full resuscitation equipment and medication ready. All patients will be in the supine position . Under ultrasound guidance a 22 Gauge, two inch Pajunk Sonoplex needle will be used for both techniques. The calculated dose of local anaeshetic will be injected bilateraly with intermittent aspiration. The spread of injectate will be seed on ultrasound. All patients will receive the routine postoperative analgesia, comprising patient-controlled IV morphine analgesia and regular diclofenac and paracetamol. All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 2, 4, 6, 12, 24, 36, and 48 h postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadratus Lumborum block group
Arm Type
Active Comparator
Arm Description
Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%
Arm Title
Transversus abdominis plane block group
Arm Type
Active Comparator
Arm Description
Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125%
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum block
Other Intervention Name(s)
QLB
Intervention Description
0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle
Intervention Type
Procedure
Intervention Name(s)
Tranversus Abdominis plane block
Other Intervention Name(s)
TAP
Intervention Description
0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.
Primary Outcome Measure Information:
Title
Total morphine used in the first 48 hours after surgery
Description
Total cumulative morphine dose in mg used in the first 48 hours after surgery
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Severity of postoperative pain via visual analogue pain scale (VAS)
Description
VAS range from 0 for no pain to 10 for worst pain imaginable
Time Frame
48 hours
Title
Nausea or vomiting
Description
0 = No Nausea = Mild Nausea. = Moderate = Severe Nausea or Vomiting
Time Frame
48 hours
Title
Sedation score
Description
= drowsy but responds to normal verbal communication. = asleep, but awakes with verbal communication. = asleep, awakens with mild physical stimulation. = asleep, unresponsive to mild physical stimulation.
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective caesarean sections ASA 1 to 3 Written informed consent. Exclusion Criteria: Patient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous patient controlled analgesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafa Blanco, FRCA
Organizational Affiliation
Corniche Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek Ansari, FFARCSI
Organizational Affiliation
Corniche Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nanda Shetty, MD
Organizational Affiliation
Corniche Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corniche Hospital
City
Abu Dhabi
ZIP/Postal Code
3788
Country
United Arab Emirates

12. IPD Sharing Statement

Citations:
PubMed Identifier
27755488
Citation
Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495. Erratum In: Reg Anesth Pain Med. 2018;43:111.
Results Reference
derived

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Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section

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