Epidural Morphine Following Vaginal Delivery

Pain Clinical Trial

Official title:

Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803114
• Other study ID #: MSHREB 01-0227-A
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2008
• Last updated: January 13, 2009
• Start date: March 2002
• Est. completion date: February 2005

Study information

• Verified date: December 2008
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The investigators believe that pain management following a vaginal delivery can be improved. Many women receive epidural medication during labor and delivery, and the investigators felt that using the epidural following delivery might improve the first day pain. This study is to determine whether a single dose of epidural morphine given to mothers after a vaginal delivery will reduce the perineal pain in the postpartum period.

Description:

Vaginal deliveries comprise 80-85% of all deliveries. Although this is felt to be natural and safe, this route can be associated with significant perineal trauma and subsequent postpartum perineal pain. The degree of perineal trauma varies from the minimum of vaginal stretching and distension associated with labor, to episiotomy and significant perineal tears. In spite of the differences in the degree of injury following vaginal delivery, postpartum pain therapy is poorly organized and at best consists of simple analgesics and anti-inflammatory drugs. The purpose of this study is to determine if a single dose of epidural-administered morphine offers additional advantage to an organized program for the management of immediate postpartum perineal pain following vaginal delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: February 2005
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy parturients (ASA 1 or 2) of > 34 weeks gestational age who chose epidural analgesia for labor, and deliver vaginally.

Exclusion Criteria:

• Women whose labor is terminated by cesarean delivery

• Parturients with known morphine allergy

• Parturients with narcotic addiction past / present

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Preservative-free epidural morphine
One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery
• Placebo
5 ml of epidural preservative-free saline given within one hour following vaginal delivery

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Goodman SR, Drachenberg AM, Johnson SA, Negron MA, Kim-Lo SH, Smiley RM. Decreased postpartum use of oral pain medication after a single dose of epidural morphine. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):134-9. — View Citation

Macdonald R, Smith PJ. Extradural morphine and pain relief following episiotomy. Br J Anaesth. 1984 Nov;56(11):1201-5. — View Citation

Niv D, Wolman I, Yashar T, Varrassi G, Rudick V, Geller E. Epidural morphine pretreatment for postepisiotomy pain. Clin J Pain. 1994 Dec;10(4):319-23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum		24 hours postpartum	No
Secondary	Time to First Request for Analgesia		Hours	No
Secondary	Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic		by 24 hours postpartum	No
Secondary	Maternal Satisfaction With Perineal Pain Management		at 24 hours postpartum	No
Secondary	Side Effects		at 24 hours postpartum	Yes