Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Quadratus Lumborum block
Sponsored by

About this trial
This is an interventional treatment trial for Postoperative Pain
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
Sites / Locations
- Corniche Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Quadratus Lumborum block group (QL)
Control Group
Arm Description
patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%
patients will receive a bilateral placebo block
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
Nausea or vomiting
Categorical assessment of nausea. 0 = No Nausea
= Mild Nausea.
= Moderate
= Severe Nausea or Vomit
Sedation score in the first 48 hours
Categorical assessment of sedation. 0 = wide awake
= 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.
Severity of postoperative pain via visual analogue pain scale
VAS range from 0 for no pain to 10 for worst pain imaginable
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02328378
Brief Title
Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?
Official Title
Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Tarek Ansari
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 produces extensive analgesia and prolonged action of the injected local anesthetic solution.
Previous studies showed that TAP block may not be effective in improving postoperative analgesia in patients who had cesarean section under spinal anaesthesia.
The aim of this randomised controlled, double blinded study is to examine the effect of QLB on the postoperative pain management 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 25 patients 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 undergo QLB with Bupivacaine versus placebo(saline) after their surgery. Allocation will be done using closed envelope technique.
The study medications/placebo will be prepared and labelled by an anesthetist who is not involved in the study.
All patients will receive a standard spinal anesthetic. At the end of surgery , Quadratus lumborum block group (QL) patients will receive bilateral QLB with 0.125% bupivacaine.
Control group patients will receive a bilateral placebo block using saline. The block 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.
The patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers.
A 22 Gauge, two inch Pajunk Sonoplex needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. Following negative aspiration, 0.2 ml/kg of 0.125% bupivacaine, or placebo(saline) is injected in each side with intermittent aspiration and the spread of injectate followed 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
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quadratus Lumborum block group (QL)
Arm Type
Active Comparator
Arm Description
patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
patients will receive a bilateral placebo block
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum block
Intervention Description
Patients will receive a bilateral Quadratus Lumborum block using 0.125% Bupivacaine in a dose of 0.2ml/kg body weight, after the end of surgery.
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
Nausea or vomiting
Description
Categorical assessment of nausea. 0 = No Nausea
= Mild Nausea.
= Moderate
= Severe Nausea or Vomit
Time Frame
48 hours
Title
Sedation score in the first 48 hours
Description
Categorical assessment of sedation. 0 = wide awake
= 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
Title
Severity of postoperative pain via visual analogue pain scale
Description
VAS range from 0 for no pain to 10 for worst pain imaginable
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
Emad Girgis, 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
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
derived
Learn more about this trial
Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?
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