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Quadratus Lumborum Block for Post-Cesarean Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02339766
Recruitment Status : Unknown
Verified February 2017 by Shalini Dhir, Lawson Health Research Institute.
Recruitment status was:  Recruiting
First Posted : January 15, 2015
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Shalini Dhir, Lawson Health Research Institute

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Quadratus Lumborum Block Procedure: Sham Block Drug: Intrathecal Morphine Drug: Intrathecal Saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Intrathecal Morphine With Quadratus Lumborum Block for Post-Cesarean Delivery Analgesia:
Actual Study Start Date : October 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.
Procedure: Quadratus Lumborum Block
Quadratus Lumborum Block with Ropivacaine 0.5% will be done.

Drug: Intrathecal Morphine
Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.
Other Name: Spinal Morphine




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pain and Morphine consumption at 6,12 24 hrs after surgery. [ Time Frame: 24 hours ]
    Numeric Rating Scale to evaluate pain scores.

  2. Nausea at 6, 12, 24 hrs after surgery [ Time Frame: 24 hours ]
    Nausea will be evaluated according to intensity. 0= no nausea; 1= nausea not requiring pharmacologic treatment; 2= nausea requiring pharmacologic treatment.

  3. Chronic Wound Pain at 6 weeks [ Time Frame: 6 weeks ]
    Development of chronic pain around incisional wound will be evaluated by phone interview.

  4. Pruritus at 6, 12, 24 hrs after surgery [ Time Frame: 24 hours ]
    Pruritus will be evaluated according to intensity 0= no pruritus; 1= pruritus not requiring pharmacologic treatment; 2= pruritus requiring pharmacologic treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339766


Contacts
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Contact: Shalini Dhir, MD, FRCPC +1(519)646-6000 ext 64219 shalini.dhir@sjhc.london.on.ca
Contact: Ilana Sebbag, MD +1(519)646-6000 ext 64219 ilana.sebbag@gmail.com

Locations
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Canada, Ontario
Victoria Hospital- LHSC Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Ilana Sebbag, MD    +15196858500 ext 13545      
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Shalini Dhir, MD, FRCPC University of Western Ontario, Canada
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Responsible Party: Shalini Dhir, Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02339766    
Other Study ID Numbers: 106224
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shalini Dhir, Lawson Health Research Institute:
Cesarean
Quadratus Lumborum Block
Analgesia
Ultrasonography
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents