A Randomized Controlled Trial Comparing Intrathecal Morphine With Quadratus Lumborum Block for Post-cesarean Delivery Analgesia

Not Applicable

• Conditions: Cesarean Section
• Interventions: Other: Bilateral Quadratus lumborum block with 0.5% ropivacaine; Other: Intrathecal Morphine with 100 mcg morphine

• Registration Number: NCT02871713
• Lead Sponsor: Vishal Uppal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Study Start: 2017-05-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-03
• Last Update Posted: 2021-01-05
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus lumborum block	Bilateral Quadratus lumborum block with 0.5% ropivacaine	Bilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg)
Intrathecal morphine + Quadratus lumborum block	Intrathecal Morphine with 100 mcg morphine	Bilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg) + Intrathecal morphine 100 mcg
Intrathecal morphine	Intrathecal Morphine with 100 mcg morphine	Intrathecal morphine 100 mcg
Intrathecal morphine + Quadratus lumborum block	Bilateral Quadratus lumborum block with 0.5% ropivacaine	Bilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg) + Intrathecal morphine 100 mcg

Primary Outcome Measures

Name	Time	Method
Quality of recovery (QoR) score	24 hours

Secondary Outcome Measures

Name	Time	Method
Quality of recovery (QoR) score	48 hours
Incidence of nausea/vomiting needing treatment	24 hours
Incidence of itching needing treatment.	24 hours
Morphine equivalent consumption	24 hours and 48 hours	morphine equivalent consumption in the 24-h and 48-h period after spinal insertion
Incidence of respiratory depression needing treatment.	24 hours
Worst pain scores	24 hours	The primary outcome will be highest pain intensity during first 24-h as measured

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Canada