Quadratus Lumborum Block for Post-Cesarean Analgesia

NCT02339766 | Terminated

• 1 other identifier: 106224
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Cesarean; Quadratus Lumborum Block; Analgesia; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Pain on movement at 12 hrs after surgery

  Numeric Rating Scale to evaluate pain scores at 12 h after surgery.

  12 hours

Secondary Outcomes (4)

• Pain and Morphine consumption at 6,12 24 hrs after surgery.

  24 hours

• Nausea at 6, 12, 24 hrs after surgery

  24 hours

• Chronic Wound Pain at 6 weeks

  6 weeks

• Pruritus at 6, 12, 24 hrs after surgery

  24 hours

Study Arms (3)

Group 1

SHAM COMPARATOR

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; Drug: Intrathecal Morphine

Group 2

ACTIVE COMPARATOR

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; Drug: Intrathecal Saline

Group 3

ACTIVE COMPARATOR

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.

Procedure: Quadratus Lumborum Block; Drug: Intrathecal Morphine

Interventions

Quadratus Lumborum Block PROCEDURE

Quadratus Lumborum Block with Ropivacaine 0.5% will be done.

Group 2; Group 3

Sham Block PROCEDURE

Sham block of Quadratus Lumborum will be done with Saline.

Group 1

Intrathecal Morphine DRUG

Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.

Also known as: Spinal Morphine

Group 1; Group 3

Intrathecal Saline DRUG

Intrathecal Saline 0.15 mL will be co-administered with the spinal anesthetic.

Also known as: Placebo

Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Victoria Hospital- LHSC

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Shalini Dhir, MD, FRCPC

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 15, 2015
• Study Start: October 1, 2015
• Primary Completion: February 5, 2017
• Study Completion: February 5, 2017
• Last Updated: October 22, 2021

Record last verified: 2021-09

Locations

CA (1)