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Cesarean SectionNCT02871713

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

A study testing Bilateral Quadratus lumborum block with 0.5% ropivacaine and Intrathecal Morphine with 100 mcg morphine in people with Cesarean Section, run by Nova Scotia Health Authority at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cesarean Section
What is being tested?
Bilateral Quadratus lumborum block with 0.5% ropivacaine and Intrathecal Morphine with 100 mcg morphine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
30 May 2017to 27 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • IWK Health Centre

    Halifax

Other trials in Canada

About this study

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

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.

Being tested
Bilateral Quadratus lumborum block with 0.5% ropivacaine, Intrathecal Morphine with 100 mcg morphine
Keywords
quadratus lumborum block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral Quadratus lumborum block with 0.5% ropivacaineOther

    Bilateral Quadratus lumborum block with 0.5% ropivacaine

  • Intrathecal Morphine with 100 mcg morphineOther

    Intrathecal Morphine with 100 mcg morphine

Study groups in NCT02871713
Study groupRoleWhat they receive
Intrathecal morphineActive comparatorIntrathecal morphine 100 mcg
Receives: Other: Intrathecal Morphine with 100 mcg morphine
Quadratus lumborum blockExperimentalBilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg)
Receives: Other: Bilateral Quadratus lumborum block with 0.5% ropivacaine
Intrathecal morphine + Quadratus lumborum blockExperimentalBilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg) + Intrathecal morphine 100 mcg
Receives: Other: Bilateral Quadratus lumborum block with 0.5% ropivacaine; Other: Intrathecal Morphine with 100 mcg morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of recovery (QoR) score

    Measured: 24 hours

Secondary outcomes (6)

  1. Morphine equivalent consumption

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

    Measured: 24 hours and 48 hours

  2. Quality of recovery (QoR) score

    Measured: 48 hours

  3. Incidence of nausea/vomiting needing treatment

    Measured: 24 hours

  4. Incidence of itching needing treatment.

    Measured: 24 hours

  5. Incidence of respiratory depression needing treatment.

    Measured: 24 hours

  6. Worst pain scores

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

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2016 (estimated)
  2. Study start30 May 2017
  3. Primary completion27 Oct 2023
  4. Study completion27 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871713
Sponsor's protocol ID
1021219
Status last verified
Sep 2024
First submitted
15 Aug 2016
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.

    PubMed 18818022

  • 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.

    PubMed 10598635

  • Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.

    PubMed 18713913

  • Loane H, Preston R, Douglas MJ, Massey S, Papsdorf M, Tyler J. A randomized controlled trial comparing intrathecal morphine with transversus abdominis plane block for post-cesarean delivery analgesia. Int J Obstet Anesth. 2012 Apr;21(2):112-8. doi: 10.1016/j.ijoa.2012.02.005. Epub 2012 Mar 10.

    PubMed 22410586

  • 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.

    PubMed 24764186

  • 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.

    PubMed 23811424

  • 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.

    PubMed 26225500

  • Uppal V, Zaphiratos V, Allen VM, Sjaus A, Shephard A, Clairoux A, Issa R, Richebe P, McKeen DM. Comparison of intrathecal morphine, lateral quadratus lumborum block, and their combination for analgesia and quality of recovery after Caesarean delivery: a randomised, double-blind, two-centre clinical trial. Br J Anaesth. 2026 Jul 9:S0007-0912(26)00410-1. doi: 10.1016/j.bja.2026.04.081. Online ahead of print.

    PubMed 42425793

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral Quadratus lumborum block with 0.5% ropivacaine and Intrathecal Morphine with 100 mcg morphine in people with Cesarean Section, run by Nova Scotia Health Authority at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of recovery (QoR) score (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02871713, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024; AzTrials last refreshed its copy on 3 Nov 2026.

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