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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-30

Study Completion Date

2024-04-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intrathecal morphine

Intrathecal morphine 100 mcg

Group Type ACTIVE_COMPARATOR

Intrathecal Morphine with 100 mcg morphine

Intervention Type OTHER

Intrathecal Morphine with 100 mcg morphine

Quadratus lumborum block

Bilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg)

Group Type EXPERIMENTAL

Bilateral Quadratus lumborum block with 0.5% ropivacaine

Intervention Type OTHER

Bilateral Quadratus lumborum block with 0.5% ropivacaine

Intrathecal morphine + Quadratus lumborum block

Bilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg) + Intrathecal morphine 100 mcg

Group Type EXPERIMENTAL

Bilateral Quadratus lumborum block with 0.5% ropivacaine

Intervention Type OTHER

Bilateral Quadratus lumborum block with 0.5% ropivacaine

Intrathecal Morphine with 100 mcg morphine

Intervention Type OTHER

Intrathecal Morphine with 100 mcg morphine

Interventions

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Bilateral Quadratus lumborum block with 0.5% ropivacaine

Intervention Type OTHER

Intrathecal Morphine with 100 mcg morphine

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No