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Clinical Trials/NCT02339766
NCT02339766
Terminated
Not Applicable

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

Lawson Health Research Institute1 site in 1 country8 target enrollmentOctober 1, 2015

Overview

Phase
Not Applicable
Intervention
Sham Block
Conditions
Postoperative Pain
Sponsor
Lawson Health Research Institute
Enrollment
8
Locations
1
Primary Endpoint
Pain on movement at 12 hrs after surgery
Status
Terminated
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2015
End Date
February 5, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

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.

Intervention: Sham Block

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.

Intervention: Intrathecal Morphine

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.

Intervention: Quadratus Lumborum Block

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.

Intervention: Intrathecal Saline

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.

Intervention: Quadratus Lumborum Block

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.

Intervention: Intrathecal Morphine

Outcomes

Primary Outcomes

Pain on movement at 12 hrs after surgery

Time Frame: 12 hours

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

Secondary Outcomes

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

Study Sites (1)

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