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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Morphine | Experimental | 2.5 mg dose of epidural morphine given within one hour following vaginal delivery |
|
| Placebo | Placebo Comparator | 5 ml of epidural preservative-free saline given within one hour following vaginal delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservative-free epidural morphine | Drug | One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum | 24 hours postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Request for Analgesia | All participants requested analgesia at least once during their hospitalization | Hours |
| Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison J Macarthur, MD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15765455 | Background | 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. | |
| 6386019 | Background | 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. |
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Parturients were approached prior to delivery if they had received epidural analgesia for labor. Following a vaginal delivery, the subject was randomized to one of the two arms.
Parturients were recruited at Mount Sinai Hospital labor and delivery unit. Recruitment took place between March 2002 and November 2004.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epidural Morphine | 2.5 mg dose of epidural morphine given within one hour following vaginal delivery |
| FG001 | Placebo | 5 ml of epidural preservative-free saline given within one hour following vaginal delivery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epidural Morphine | 2.5 mg dose of epidural morphine given within one hour following vaginal delivery |
| BG001 | Placebo | 5 ml of epidural preservative-free saline given within one hour following vaginal delivery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum | Analysis by intention to treat. | Posted | Number | participants | 24 hours postpartum |
|
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Macarthur | University of Toronto | 416 586 4800 | 6632 | alison.macarthur@uhn.on.ca |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| Placebo | Drug | 5 ml of epidural preservative-free saline given within one hour following vaginal delivery |
|
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"
| 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. | at 24 hours postpartum |
| Side Effects | Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum | at 24 hours postpartum |
| 7858363 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number of caucasian, non-caucasian study subjects | Number | Participants |
|
| Operative vaginal delivery | Number of study subjects with spontaneous, operative vaginal delivery | Number | participants |
|
| Parity | Number of primiparous, multiparous study subjects | Number | participants |
|
| Perineal Trauma | Number of subjects with minimal, major perineal tears | Number | Participants |
|
| Maternal Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Neonatal Birth Weight | Mean | Standard Deviation | kilograms |
|
| Participants |
|
|
|
| Secondary | Time to First Request for Analgesia | All participants requested analgesia at least once during their hospitalization | Posted | Mean | Standard Deviation | hours | Hours |
|
|
|
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| Secondary | 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" | Posted | Mean | Standard Deviation | scores on a scale | by 24 hours postpartum |
|
|
|
|
| Secondary | 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. | Posted | Number | participants | at 24 hours postpartum |
|
|
|
|
| Secondary | Side Effects | Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum | Not Posted | Number | Number of participants | at 24 hours postpartum |
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Not sure |
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| Agree |
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| Strongly Agree |
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| Missing information |
|