PainPhase 4NCT00803114
Epidural Morphine Following Vaginal Delivery
A Phase 4 study testing Preservative-free epidural morphine in people with Pain, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Preservative-free epidural morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2002to Feb 2005
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy parturients (ASA 1 or 2) of > 34 weeks gestational age who chose epidural analgesia for labor, and deliver vaginally.
Who cannot join
- Women whose labor is terminated by cesarean delivery
- Parturients with known morphine allergy
- Parturients with narcotic addiction past / present
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial
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.
Read the detailed 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.
- Conditions
- Pain
- Being tested
- Preservative-free epidural morphine, Placebo
- Keywords
- Postpartum perineal pain, Epidural morphine, Randomised clinical trial
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative-free epidural morphineDrug
Also called Morphine, Epidural Narcotics
One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery
PlaceboDrug
5 ml of epidural preservative-free saline given within one hour following vaginal delivery
| Study group | Role | What they receive |
|---|---|---|
| Epidural Morphine | Experimental | 2.5 mg dose of epidural morphine given within one hour following vaginal delivery Receives: Drug: Preservative-free epidural morphine |
| Placebo | Placebo comparator | 5 ml of epidural preservative-free saline given within one hour following vaginal delivery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum
Measured: 24 hours postpartum
Secondary outcomes (4)
Time to First Request for Analgesia
All participants requested analgesia at least once during their hospitalization
Measured: Hours
Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic
Participants were asked to indicate on a 10 cm line the point at which their perineal pain scored between one end anchored with "no pain in my bottom" to the other end anchored with "the worst pain in my bottom that I can imagine"
Measured: by 24 hours postpartum
Maternal Satisfaction With Perineal Pain Management
5 point Likert scale asking for agreement with the statement "I was satisfied with my pain relief for the pain in my bottom during the first day after delivery". Scale ranged from strongly disagree to strongly agree.
Measured: at 24 hours postpartum
Side Effects
Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum
Measured: at 24 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startMar 2002
- Primary completionNov 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Alison J Macarthur, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803114
- Sponsor's protocol ID
- MSHREB 01-0227-A
- Status last verified
- Dec 2008
- First submitted
- 7 Nov 2008
- Last updated
- 14 Jan 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 15765455Macdonald 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.
PubMed 6386019Niv 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.
PubMed 7858363
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00803114
- Acronym / sponsor ID
- MSHREB 01-0227-A
- Conditions
- Pain
- Keywords
- Postpartum perineal pain, Epidural morphine, Randomised clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Mar 2002
- Primary completion
- Nov 2004 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 5 Dec 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Morphine | Experimental | Drug: Preservative-free epidural morphine2.5 mg dose of epidural morphine given within one hour following vaginal delivery |
| Placebo | Placebo comparator | Drug: Placebo5 ml of epidural preservative-free saline given within one hour following vaginal delivery |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy parturients (ASA 1 or 2) of > 34 weeks gestational age who chose epidural analgesia for labor, and deliver vaginally.
Key exclusion criteria (3 listed)
- Women whose labor is terminated by cesarean delivery
- Parturients with known morphine allergy
- Parturients with narcotic addiction past / present
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preservative-free epidural morphineAlso: Morphine, Epidural NarcoticsOne time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery | Drug | Epidural Morphine |
| Placebo5 ml of epidural preservative-free saline given within one hour following vaginal delivery | Drug | Placebo |
Primary outcome
The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum
Time frame: 24 hours postpartum
4 secondary outcomes
Time to First Request for Analgesia
Time frame: Hours
Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic
Time frame: by 24 hours postpartum
Maternal Satisfaction With Perineal Pain Management
Time frame: at 24 hours postpartum
Side Effects
Time frame: at 24 hours postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15765455Goodman 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.
- Background: PubMed 6386019Macdonald 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.
- Background: PubMed 7858363Niv 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison J Macarthur, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preservative-free epidural morphine in people with Pain, run by Mount Sinai Hospital, Canada 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 1 inclusion and 3 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 14 Jan 2009. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum (time frame: 24 hours postpartum). 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 NCT00803114, which also lists 3 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 14 Jan 2009.