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

Cesarean Section Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02871713
• Other study ID #: 1021219
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2021
• Source: Nova Scotia Health Authority
• Contact: Vishal Uppal, FRCA
• Phone: 9024706627
• Email: Lorraine.Chiasson[@]iwk.nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax

Sponsors (3)

Lead Sponsor	Collaborator
Vishal Uppal	IWK Health Centre, Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View Citation

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. — View Citation

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

Dahl JB, Jeppesen IS, Jørgensen H, Wetterslev J, Møiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative syst — View Citation

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 — View Citation

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: 10.101 — View Citation

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of recovery (QoR) score		24 hours
Secondary	Morphine equivalent consumption	morphine equivalent consumption in the 24-h and 48-h period after spinal insertion	24 hours and 48 hours
Secondary	Quality of recovery (QoR) score		48 hours
Secondary	Incidence of nausea/vomiting needing treatment		24 hours
Secondary	Incidence of itching needing treatment.		24 hours
Secondary	Incidence of respiratory depression needing treatment.		24 hours
Secondary	Worst pain scores	The primary outcome will be highest pain intensity during first 24-h as measured	24 hours