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Completed

NCT Number: NCT02871713

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre

Halifax, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bilateral Quadratus lumborum block with 0.5% ropivacaine

Other

Bilateral Quadratus lumborum block with 0.5% ropivacaine

Intrathecal Morphine with 100 mcg morphine

Other

Intrathecal Morphine with 100 mcg morphine

Primary outcomes

  1. Quality of recovery (QoR) score

    Time frame: 24 hours

Secondary outcomes

  1. Morphine equivalent consumption

    Time frame: 24 hours and 48 hours

    morphine equivalent consumption in the 24-h and 48-h period after spinal insertion

  2. Quality of recovery (QoR) score

    Time frame: 48 hours

  3. Incidence of nausea/vomiting needing treatment

    Time frame: 24 hours

  4. Incidence of itching needing treatment.

    Time frame: 24 hours

  5. Incidence of respiratory depression needing treatment.

    Time frame: 24 hours

  6. Worst pain scores

    Time frame: 24 hours

    The primary outcome will be highest pain intensity during first 24-h as measured

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • IWK Health Centre
  • Maisonneuve-Rosemont Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Aug 18, 2016
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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