NCT00803114

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
Same day until next milestone

Results Posted

Study results publicly available

December 5, 2008

Completed
Last Updated

January 14, 2009

Status Verified

December 1, 2008

Enrollment Period

2.7 years

First QC Date

November 7, 2008

Results QC Date

November 7, 2008

Last Update Submit

January 13, 2009

Conditions

Pain

Keywords

Postpartum perineal painEpidural morphineRandomised clinical trial

Outcome Measures

Primary Outcomes (1)

  • The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum

    24 hours postpartum

Secondary Outcomes (4)

  • Time to First Request for Analgesia

    Hours

  • Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic

    by 24 hours postpartum

  • Maternal Satisfaction With Perineal Pain Management

    at 24 hours postpartum

  • Side Effects

    at 24 hours postpartum

Study Arms (2)

Epidural Morphine

EXPERIMENTAL

2.5 mg dose of epidural morphine given within one hour following vaginal delivery

Drug: Preservative-free epidural morphine

Placebo

PLACEBO COMPARATOR

5 ml of epidural preservative-free saline given within one hour following vaginal delivery

Drug: Placebo

Interventions

Preservative-free epidural morphineDRUG

One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery

Also known as: Morphine, Epidural Narcotics
Epidural Morphine
PlaceboDRUG

5 ml of epidural preservative-free saline given within one hour following vaginal delivery

Placebo

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Women whose labor is terminated by cesarean delivery
  • Parturients with known morphine allergy
  • Parturients with narcotic addiction past / present

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related 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. doi: 10.1016/j.rapm.2004.11.010.

    PMID: 15765455BACKGROUND

  • Macdonald R, Smith PJ. Extradural morphine and pain relief following episiotomy. Br J Anaesth. 1984 Nov;56(11):1201-5. doi: 10.1093/bja/56.11.1201.

    PMID: 6386019BACKGROUND

  • 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. doi: 10.1097/00002508-199412000-00013.

    PMID: 7858363BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Dr. Alison Macarthur
Organization
University of Toronto
alison.macarthur@uhn.on.ca
416 586 4800

Study Officials

  • Alison J Macarthur, MD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2008

First Posted

December 5, 2008

Study Start

March 1, 2002

Primary Completion

November 1, 2004

Study Completion

February 1, 2005

Last Updated

January 14, 2009

Results First Posted

December 5, 2008

Record last verified: 2008-12

Locations

CA(1)