Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2015-10-01
2017-02-05
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Sham Block
Sham block of Quadratus Lumborum will be done with Saline.
Intrathecal Morphine
Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.
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.
Quadratus Lumborum Block
Quadratus Lumborum Block with Ropivacaine 0.5% will be done.
Intrathecal Saline
Intrathecal Saline 0.15 mL will be co-administered with the spinal anesthetic.
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.
Quadratus Lumborum Block
Quadratus Lumborum Block with Ropivacaine 0.5% will be done.
Intrathecal Morphine
Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.
Interventions
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Quadratus Lumborum Block
Quadratus Lumborum Block with Ropivacaine 0.5% will be done.
Sham Block
Sham block of Quadratus Lumborum will be done with Saline.
Intrathecal Morphine
Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.
Intrathecal Saline
Intrathecal Saline 0.15 mL will be co-administered with the spinal anesthetic.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists Physical Status 1-3
* Suitable for procedure to be carried out under spinal anesthesia
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Shalini Dhir, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of Western Ontario, Canada
Locations
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Victoria Hospital- LHSC
London, Ontario, Canada
Countries
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Other Identifiers
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106224
Identifier Type: -
Identifier Source: org_study_id