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Quadratus Lumborum Block for Post-Cesarean Analgesia

Primary Purpose

Postoperative Pain

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Quadratus Lumborum Block
Sham Block
Intrathecal Morphine
Intrathecal Saline
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Cesarean, Quadratus Lumborum Block, Analgesia, Ultrasonography

Eligibility Criteria

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

Inclusion Criteria:

  • Elective cesarean delivery
  • American Society of Anesthesiologists Physical Status 1-3
  • Suitable for procedure to be carried out under spinal anesthesia

Exclusion Criteria:

  • Inability to give informed consent or to co-operate with post-operative evaluation
  • Allergy to local anesthetics, morphine, fentanyl, ropivacaine
  • Ongoing major medical or psychiatric problems
  • Chronic opioid use
  • Major coagulopathy
  • BMI>35 on first ante natal visit
  • Pre-eclampsia
  • Contraindication to neuraxial anesthesia

Sites / Locations

  • Victoria Hospital- LHSC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

Group 1 will receive intrathecal morphine co-administered with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Sham Block be done with 25 mL of saline per side.

Group 2 will receive an equivalent volume of intrathecal saline co-administered with the spinal anesthetic. After surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side.

Group 3 will receive will receive intrathecal morphine with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side.

Outcomes

Primary Outcome Measures

Pain on movement at 12 hrs after surgery
Numeric Rating Scale to evaluate pain scores at 12 h after surgery.

Secondary Outcome Measures

Pain and Morphine consumption at 6,12 24 hrs after surgery.
Numeric Rating Scale to evaluate pain scores.
Nausea at 6, 12, 24 hrs after surgery
Nausea will be evaluated according to intensity. 0= no nausea; 1= nausea not requiring pharmacologic treatment; 2= nausea requiring pharmacologic treatment.
Chronic Wound Pain at 6 weeks
Development of chronic pain around incisional wound will be evaluated by phone interview.
Pruritus at 6, 12, 24 hrs after surgery
Pruritus will be evaluated according to intensity 0= no pruritus; 1= pruritus not requiring pharmacologic treatment; 2= pruritus requiring pharmacologic treatment.

Full Information

First Posted
January 6, 2015
Last Updated
October 19, 2021
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02339766
Brief Title
Quadratus Lumborum Block for Post-Cesarean Analgesia
Official Title
Comparison of Intrathecal Morphine With Quadratus Lumborum Block for Post-Cesarean Delivery Analgesia:
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Not feasible due to difficulty with recruitment.
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
February 5, 2017 (Actual)
Study Completion Date
February 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Most women having planned cesarean section receive spinal anesthetic for the procedure. Typically, spinal opioids are administered during the same time as a component of multimodal analgesia to provide pain relief in the 16-24 hr period postoperatively. However, spinal opioids are frequently associated with adverse effects such as nausea, pruritus, sedation and occasionally respiratory depression. The quadratus lumborum (QL) block is a regional analgesic technique which blocks T5-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries and is a potential alternative to spinal opioids. There is some evidence that it may provide visceral along with somatic pain relief. It is a simple and safe technique that has been studied in lower abdominal surgeries, but has not been studied for pain relief after cesarean section. If found effective, it will have the advantage of a reduction in opioid associated adverse effects while providing similar quality of analgesia. This block has evolved from the previously known transversus abdominis plane block. We propose to undertake a study that will compare the relative efficacy of QL block with local anesthetic to spinal morphine. We will also study if it provides any incremental benefit when administered in addition to spinal morphine.
Detailed Description
This will be a randomized controlled double blinded trial. Seventy five female patients belonging to American Society of Anesthesiologists status 1-3, age 18-45 yrs undergoing elective caesarean delivery will be included in this prospective study. After obtaining informed consent, they will be randomized to one of the three groups by a computer-generated randomization. All patients will receive standard spinal anesthetic. They will be randomized to one of the three groups (n=25 per group). Groups 1 and 3 will receive intrathecal morphine in addition to the spinal anesthestic. Group 2 will receive equal volume of saline added to the intrathecal mixture. Ultrasound guided Quadratus Lumborum block will be done. Following negative aspiration, 25 mL of Ropivacaine 0.5% (Groups 2 and 3), or the same amount of saline (Group 1) will be injected in each side. All patients will receive routine postoperative analgesia, including analgesics and oral morphine. All patients will be assessed postoperatively by a blinded investigator at 6, 12 and 24h post-operatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Cesarean, Quadratus Lumborum Block, Analgesia, Ultrasonography

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Sham Comparator
Arm Description
Group 1 will receive intrathecal morphine co-administered with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Sham Block be done with 25 mL of saline per side.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Group 2 will receive an equivalent volume of intrathecal saline co-administered with the spinal anesthetic. After surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Group 3 will receive will receive intrathecal morphine with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side.
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Block
Intervention Description
Quadratus Lumborum Block with Ropivacaine 0.5% will be done.
Intervention Type
Procedure
Intervention Name(s)
Sham Block
Intervention Description
Sham block of Quadratus Lumborum will be done with Saline.
Intervention Type
Drug
Intervention Name(s)
Intrathecal Morphine
Other Intervention Name(s)
Spinal Morphine
Intervention Description
Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.
Intervention Type
Drug
Intervention Name(s)
Intrathecal Saline
Other Intervention Name(s)
Placebo
Intervention Description
Intrathecal Saline 0.15 mL will be co-administered with the spinal anesthetic.
Primary Outcome Measure Information:
Title
Pain on movement at 12 hrs after surgery
Description
Numeric Rating Scale to evaluate pain scores at 12 h after surgery.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Pain and Morphine consumption at 6,12 24 hrs after surgery.
Description
Numeric Rating Scale to evaluate pain scores.
Time Frame
24 hours
Title
Nausea at 6, 12, 24 hrs after surgery
Description
Nausea will be evaluated according to intensity. 0= no nausea; 1= nausea not requiring pharmacologic treatment; 2= nausea requiring pharmacologic treatment.
Time Frame
24 hours
Title
Chronic Wound Pain at 6 weeks
Description
Development of chronic pain around incisional wound will be evaluated by phone interview.
Time Frame
6 weeks
Title
Pruritus at 6, 12, 24 hrs after surgery
Description
Pruritus will be evaluated according to intensity 0= no pruritus; 1= pruritus not requiring pharmacologic treatment; 2= pruritus requiring pharmacologic treatment.
Time Frame
24 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 cesarean delivery American Society of Anesthesiologists Physical Status 1-3 Suitable for procedure to be carried out under spinal anesthesia Exclusion Criteria: Inability to give informed consent or to co-operate with post-operative evaluation Allergy to local anesthetics, morphine, fentanyl, ropivacaine Ongoing major medical or psychiatric problems Chronic opioid use Major coagulopathy BMI>35 on first ante natal visit Pre-eclampsia Contraindication to neuraxial anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalini Dhir, MD, FRCPC
Organizational Affiliation
University of Western Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Hospital- LHSC
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Quadratus Lumborum Block for Post-Cesarean Analgesia

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