Pain
Conditions
Keywords
Postpartum perineal pain, Epidural morphine, Randomised clinical trial
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.
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.
Interventions
DRUGPreservative-free epidural morphine
One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery
DRUGPlacebo
5 ml of epidural preservative-free saline given within one hour following vaginal delivery
Sponsors
The Physicians' Services Incorporated Foundation
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum | 24 hours postpartum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Request for Analgesia | Hours | All participants requested analgesia at least once during their hospitalization |
| Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic | by 24 hours postpartum | 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 |
| Maternal Satisfaction With Perineal Pain Management | at 24 hours postpartum | 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. |
| Side Effects | at 24 hours postpartum | Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum |
Countries
Canada
Participant flow
Recruitment details
Parturients were recruited at Mount Sinai Hospital labor and delivery unit. Recruitment took place between March 2002 and November 2004.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Epidural Morphine 2.5 mg dose of epidural morphine given within one hour following vaginal delivery | 113 |
| Placebo 5 ml of epidural preservative-free saline given within one hour following vaginal delivery | 115 |
| Total | 228 |
Baseline characteristics
| Characteristic | Epidural Morphine | Placebo | Total |
|---|---|---|---|
| Age Continuous | 32.1 years STANDARD_DEVIATION 4.9 | 31.8 years STANDARD_DEVIATION 4.9 | 32.0 years STANDARD_DEVIATION 4.9 |
| Maternal Body Mass Index (BMI) | 29.0 kg/m2 STANDARD_DEVIATION 5.9 | 29.0 kg/m2 STANDARD_DEVIATION 6.6 | 29.0 kg/m2 STANDARD_DEVIATION 6.2 |
| Neonatal Birth Weight | 3.4 kilograms STANDARD_DEVIATION 0.51 | 3.4 kilograms STANDARD_DEVIATION 0.46 | 3.4 kilograms STANDARD_DEVIATION 0.48 |
| Operative vaginal delivery Operative vaginal delivery | 38 participants | 34 participants | 72 participants |
| Operative vaginal delivery Spontaneous vaginal delivery | 75 participants | 81 participants | 156 participants |
| Parity Multiparous | 37 participants | 36 participants | 73 participants |
| Parity Primiparous | 76 participants | 79 participants | 155 participants |
| Perineal Trauma First degree tear or less | 31 Participants | 28 Participants | 59 Participants |
| Perineal Trauma Second degree tear or greater | 82 Participants | 87 Participants | 169 Participants |
| Race/Ethnicity, Customized Caucasian | 87 Participants | 99 Participants | 186 Participants |
| Race/Ethnicity, Customized Missing information | 9 Participants | 5 Participants | 14 Participants |
| Race/Ethnicity, Customized Non-caucasian | 17 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Female | 113 Participants | 115 Participants | 228 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Outcome results
Primary
The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum
Time frame: 24 hours postpartum
Population: Analysis by intention to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epidural Morphine | The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum | 8 participants |
| Placebo | The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum | 37 participants |
Comparison: Relative risk ratio estimation with 95% CI using exact methodsp-value: 0.0595% CI: [0.12, 0.41]Fisher Exact
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.
Time frame: at 24 hours postpartum
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epidural Morphine | Maternal Satisfaction With Perineal Pain Management | Strongly Disagree | 1 participants |
| Epidural Morphine | Maternal Satisfaction With Perineal Pain Management | Disagree | 9 participants |
| Epidural Morphine | Maternal Satisfaction With Perineal Pain Management | Not sure | 6 participants |
| Epidural Morphine | Maternal Satisfaction With Perineal Pain Management | Agree | 43 participants |
| Epidural Morphine | Maternal Satisfaction With Perineal Pain Management | Strongly Agree | 45 participants |
| Epidural Morphine | Maternal Satisfaction With Perineal Pain Management | Missing information | 9 participants |
| Placebo | Maternal Satisfaction With Perineal Pain Management | Strongly Agree | 45 participants |
| Placebo | Maternal Satisfaction With Perineal Pain Management | Strongly Disagree | 3 participants |
| Placebo | Maternal Satisfaction With Perineal Pain Management | Agree | 38 participants |
| Placebo | Maternal Satisfaction With Perineal Pain Management | Disagree | 11 participants |
| Placebo | Maternal Satisfaction With Perineal Pain Management | Missing information | 10 participants |
| Placebo | Maternal Satisfaction With Perineal Pain Management | Not sure | 8 participants |
p-value: 0.8Fisher Exact
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
Time frame: by 24 hours postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Morphine | Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic | 0.3 scores on a scale | Standard Deviation 1.4 |
| Placebo | Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic | 1.6 scores on a scale | Standard Deviation 2.7 |
p-value: 0.0595% CI: [0.7, 1.8]t-test, 2 sided
Secondary
Side Effects
Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum
Time frame: at 24 hours postpartum
Secondary
Time to First Request for Analgesia
All participants requested analgesia at least once during their hospitalization
Time frame: Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Morphine | Time to First Request for Analgesia | 22.9 hours | Standard Deviation 4 |
| Placebo | Time to First Request for Analgesia | 18.9 hours | Standard Deviation 8 |
p-value: 0.0595% CI: [-5.7, -2.3]t-test, 2 sided