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

A Randomized Controlled Trial Comparing Intrathecal Morphine with Quadratus Lumborum Block As Part of a Multimodal Analgesia Strategy for Post-cesarean Delivery Analgesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02871713
Enrollment
60
Registered
2016-08-18
Start date
2017-05-30
Completion date
2024-04-27
Last updated
2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

quadratus lumborum block

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.

Interventions

OTHERBilateral Quadratus lumborum block with 0.5% ropivacaine

Bilateral Quadratus lumborum block with 0.5% ropivacaine

OTHERIntrathecal Morphine with 100 mcg morphine

Intrathecal Morphine with 100 mcg morphine

Sponsors

IWK Health Centre
CollaboratorOTHER
Maisonneuve-Rosemont Hospital
CollaboratorOTHER
Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Quality of recovery (QoR) score24 hours

Secondary

MeasureTime frameDescription
Quality of recovery (QoR) score48 hours
Incidence of nausea/vomiting needing treatment24 hours
Morphine equivalent consumption24 hours and 48 hoursmorphine equivalent consumption in the 24-h and 48-h period after spinal insertion
Incidence of respiratory depression needing treatment.24 hours
Worst pain scores24 hoursThe primary outcome will be highest pain intensity during first 24-h as measured
Incidence of itching needing treatment.24 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026