Clinical trial NCT02339766: Quadratus Lumborum Block for Post-Cesarean Analgesia
Official title: Comparison of Intrathecal Morphine With Quadratus Lumborum Block for Post-Cesarean Delivery Analgesia:
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Pain
Keywords: Cesarean
Quadratus Lumborum Block
Analgesia
Ultrasonography
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-01-15
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain on movement at 12 hrs after surgery
timeFrame: 12 hours
Secondary outcomes:
measure: Pain and Morphine consumption at 6,12 24 hrs after surgery.
timeFrame: 24 hours
measure: Nausea at 6, 12, 24 hrs after surgery
timeFrame: 24 hours
measure: Chronic Wound Pain at 6 weeks
timeFrame: 6 weeks
measure: Pruritus at 6, 12, 24 hrs after surgery
timeFrame: 24 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital- LHSC
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: Shalini Dhir, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: