Clinical trial NCT02871713: A Randomized Controlled Trial Comparing Intrathecal Morphine with Quadratus Lumborum Block for Post-cesarean Delivery Analgesia
Official title: A Randomized Controlled Trial Comparing Intrathecal Morphine with Quadratus Lumborum Block As Part of a Multimodal Analgesia Strategy for Post-cesarean Delivery Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: quadratus lumborum block
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: IWK Health Centre
name: Maisonneuve-Rosemont Hospital
First posted: 2016-08-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain after caesarean delivery (CD) can interfere with the moms' ability to look after her baby and may contribute to developing long term pain and disability. Women having a CD receive pain medication (morphine) as part of their spinal anesthetic to help with pain relief after surgery. Morphine works well however has several side effects such as nausea, vomiting and itching which may be severe enough to make it difficult to care for herself and her new baby. In some cases, morphine causes difficulty in passing urine within first 24-hours of the CD requiring catheterization and thus restricting mobilization. The quadratus lumborum block (QLB) is a newer nerve block that uses local anaesthetic solution to numb the nerves carrying pain sensation from surgical incision site. QLB may be able to provide effective pain control without the side-effects associated with the spinal morphine. This study is to determine if women receiving QLB have as good pain control with fewer side effects than those who do receive the spinal morphine. Adequate pain control will be assessed by their pain scores and recovery in the 24 to 48 hours after CD. The side effect profile of the two techniques, quality of recovery and long term impact will also be compared during this study.

In addition, we would like to compare the patients who received both analgesic regimens (ITM and QLB) with patients who received only one analgesic intervention (i.e. either ITM or QLB). Further, the study will help us answer if combining the two analgesic interventions if beneficial or not.


Eligibility criteria: Inclusion Criteria:

* Non-emergent CD with planned spinal anesthesia
* American Society of Anesthesia physical status class I \& II;
* Age ≥18 years;
* Term gestational age (≥37 weeks);
* Singleton pregnancy;
* English-speaking.

Exclusion Criteria:

* Morbid Obesity (BMI ≥35 kg/m2);
* Subjects with significant obstetric or neonatal co-morbidities;
* Patient enrollment in another study involving medication within 30 days of CD;
* Any other condition, which may impair patients ability to co-operate with data collection;
* Patient height less than 152 cm (5'0");
* History of opioid tolerance or sensitivity;
* Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs);
* Women with a history of illicit drug use or prescribed opioids or benzodiazepines.

Primary outcomes:
measure: Quality of recovery (QoR) score
timeFrame: 24 hours
Secondary outcomes:
measure: Morphine equivalent consumption
timeFrame: 24 hours and 48 hours
measure: Quality of recovery (QoR) score
timeFrame: 48 hours
measure: Incidence of nausea/vomiting needing treatment
timeFrame: 24 hours
measure: Incidence of itching needing treatment.
timeFrame: 24 hours
measure: Incidence of respiratory depression needing treatment.
timeFrame: 24 hours
measure: Worst pain scores
timeFrame: 24 hours
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
Study officials:
References:
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citation: Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.
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citation: McKeen DM, George RB, Boyd JC, Allen VM, Pink A. Transversus abdominis plane block does not improve early or late pain outcomes after Cesarean delivery: a randomized controlled trial. Can J Anaesth. 2014 Jul;61(7):631-40. doi: 10.1007/s12630-014-0162-5. Epub 2014 Apr 24.
citation: Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.
citation: Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.