Quadratus Lumborum Block for Post-Cesarean Analgesia

Comparison of Intrathecal Morphine With Quadratus Lumborum Block for Post-Cesarean Delivery Analgesia:

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Sham Block; Drug: Intrathecal Morphine; Procedure: Quadratus Lumborum Block; Drug: Intrathecal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Victoria Hospital- LHSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Group 1; 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.	Procedure: Sham Block; Sham block of Quadratus Lumborum will be done with Saline.; Drug: Intrathecal Morphine; Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.; Other Names: Spinal Morphine
ACTIVE_COMPARATOR: Group 2; 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.	Procedure: Quadratus Lumborum Block; Quadratus Lumborum Block with Ropivacaine 0.5% will be done.; Drug: Intrathecal Saline; Intrathecal Saline 0.15 mL will be co-administered with the spinal anesthetic.; Other Names: Placebo
ACTIVE_COMPARATOR: Group 3; 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.	Drug: Intrathecal Morphine; Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.; Other Names: Spinal Morphine; Procedure: Quadratus Lumborum Block; Quadratus Lumborum Block with Ropivacaine 0.5% will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on movement at 12 hrs after surgery	Numeric Rating Scale to evaluate pain scores at 12 h after surgery.	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and Morphine consumption at 6,12 24 hrs after surgery.	Numeric Rating Scale to evaluate pain scores.	24 hours
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.	24 hours
Chronic Wound Pain at 6 weeks	Development of chronic pain around incisional wound will be evaluated by phone interview.	6 weeks
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.	24 hours

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Shalini Dhir, MD, FRCPC, University of Western Ontario, Canada

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): February 5, 2017
• Study Completion (ACTUAL): February 5, 2017

Study Registration Dates

• First Submitted: January 6, 2015
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (ESTIMATE): January 15, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Analgesia; Ultrasonography; Cesarean; Quadratus Lumborum Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 106224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED