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

NCT02871713 | Completed

• 1 other identifier: 1021219
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Keywords

quadratus lumborum block

Outcome Measures

Primary Outcomes (1)

• Quality of recovery (QoR) score

  24 hours

Secondary Outcomes (6)

• Morphine equivalent consumption

  24 hours and 48 hours

• Quality of recovery (QoR) score

  48 hours

• Incidence of nausea/vomiting needing treatment

  24 hours

• Incidence of itching needing treatment.

  24 hours

• Incidence of respiratory depression needing treatment.

  24 hours

Study Arms (3)

Intrathecal morphine

ACTIVE COMPARATOR

Intrathecal morphine 100 mcg

Other: Intrathecal Morphine with 100 mcg morphine

Quadratus lumborum block

EXPERIMENTAL

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

Other: Bilateral Quadratus lumborum block with 0.5% ropivacaine

Intrathecal morphine + Quadratus lumborum block

EXPERIMENTAL

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

Other: Bilateral Quadratus lumborum block with 0.5% ropivacaine; Other: Intrathecal Morphine with 100 mcg morphine

Interventions

Bilateral Quadratus lumborum block with 0.5% ropivacaine OTHER

Bilateral Quadratus lumborum block with 0.5% ropivacaine

Intrathecal morphine + Quadratus lumborum block; Quadratus lumborum block

Intrathecal Morphine with 100 mcg morphine OTHER

Intrathecal Morphine with 100 mcg morphine

Intrathecal morphine; Intrathecal morphine + Quadratus lumborum block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• IWK Health Centre: collaborator
• Maisonneuve-Rosemont Hospital: collaborator

Study Sites (1)

IWK Health Centre

Halifax, Canada

Location

Related Publications (7)

• 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.

  PMID: 18818022 BACKGROUND

• 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.

  PMID: 10598635 BACKGROUND

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

  PMID: 18713913 BACKGROUND

• 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.

  PMID: 22410586 BACKGROUND

• 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.

  PMID: 24764186 BACKGROUND

• 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.

  PMID: 23811424 BACKGROUND

• 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.

  PMID: 26225500 BACKGROUND

MeSH Terms

Interventions

Ropivacaine; Morphine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: May 30, 2017
• Primary Completion: October 27, 2023
• Study Completion: April 27, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)