Pain, Postpartum Depression
Conditions
Brief summary
Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS. This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS. The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
Interventions
DRUGEpidural saline + IV saline
Sterile saline injection in the epidural catheter and in the intravenous catheter
DRUGEpidural morphine 3 mg + IV saline
Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
DRUGEpidural morphine 3 mg + IV ketamine 0.3 mg/kg
Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years of age * English-speaking * Vaginal delivery (spontaneous or assisted) * A full-term fetus (\>37 weeks' gestation) * OASIS as assessed by obstetrical provider * Functional epidural analgesia at time of delivery * Patient amenable to follow-up in specialty perineal clinic within the first week postpartum
Exclusion criteria
* Previous pelvic surgery * History of chronic pelvic pain * History of recurrent urinary tract infections * Women with known malformations of their urinary tract * True allergies to ketamine and/or morphine * Preeclampsia or hypertensive disorder at the time of delivery * Obstructive sleep apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries. | 1 week after vaginal delivery | Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good)and 10 highest pain (poor). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perineal Pain | Day 1 after delivery | Perineal pain day 1 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain. |
| Assessment of Maternal-infant Bonding | 1 week after delivery | Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment (poor) to 95 high maternal infant attachment (good). |
| Presence of Postpartum Depression | 1 week after delivery | Presence of postpartum depression 7 days after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low- 30 high. High scores indicate potential for depression. |
| Brief Pain Inventory (BPI-ST Short Form) Current Pain | 1 week after delivery | Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale. |
| Female Sexual Function | 3 months after delivery | Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function to 36 high sexual function. |
| Promis 29 Profile (Physical Function Question Only) | 3 month | 29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher physical function. |
| Promis 29 Profile (Anxiety Function Question Only) | 3 month | 29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 anxiety rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher anxiety. |
| Promis 29 Profile (Depressive Symptoms Question Only) | 3 month | 29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher depression. |
| Promis 29 Profile (Fatigue Question Only) | 3 month | 29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of fatigue. |
| Promis 29 Profile (Sleep Disturbance Question Only) | 3 month | 29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of sleep disturbance. |
| Promis 29 Profile (Social Function Question Only) | 3 month | 29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of social function. |
| Promis 29 Profile (Pain Interference Question Only) | 3 month | 29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates a higher level of pain interference. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFeyce Peralta, MD
Northwestern University
Baseline characteristics
| Characteristic | — |
|---|---|
| 1st Stage of Labor (minutes) | 510 Minutes |
| 2nd stage of labor (minutes) 30-60 minutes | 9 Participants |
| 2nd stage of labor (minutes) 61-120 Minutes | 19 Participants |
| 2nd stage of labor (minutes) Greater than 120 Minutes | 7 Participants |
| ACRI Questionnaire | 5 score on scale |
| Age, Continuous | 34.7 Years |
| Current Smoker | 1 Participants |
| Degree Perineal Laceration 3rd degree laceration | 55 Participants |
| Degree Perineal Laceration 4th degree laceration | 1 Participants |
| Delivery Mode Vaginal Operative | 6 Participants |
| Delivery Mode Vaginal Unassisted | 35 Participants |
| Fetal Presentation Cephalic Presentation | 46 Participants |
| Fetal Presentation Vertex Presentation | 3 Participants |
| Fetal Weight | 3555 Grams STANDARD_DEVIATION 417 |
| Gestational Age (weeks) | 39.1 Weeks STANDARD_DEVIATION 1.1 |
| Gravida 1 Time | 41 number of participants |
| Gravida 2 Times | 6 number of participants |
| Gravida Greater than 2 times | 8 number of participants |
| Labor Type Induction | 32 Participants |
| Labor Type Spontaneous | 33 Participants |
| NRS Pain Score at Study Drug Administration | 0 Score on Scale |
| Operative Type Forceps | 25 Participants |
| Operative Type Vacuum | 2 Participants |
| Oxytocin Augmentation No oxytocin augmentation | 2 Participants |
| Oxytocin Augmentation Oxytocin augmentation | 61 Participants |
| Para 1 birth | 11 number of participants |
| Para 2 births | 1 number of participants |
| Para No births | 3 number of participants |
| Plan to Breastfeed | 25 Participants |
| Prostaglandin Cervical Ripening | 16 Participants |
| Race/Ethnicity, Customized Hispanic LatinX | 1 Participants |
| Race/Ethnicity, Customized Not LatinX | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 25 participants |
| Rupture of Membranes Artificial | 12 participants |
| Rupture of Membranes Spontaneous | 25 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 0 Participants |
| Suture Repair Style Interrupted | 12 Participants |
| Suture Repair Style Interrupted + Uninterrupted | 13 Participants |
| Suture Repair Style Uninterrupted | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 4 / 14 | 14 / 26 | 13 / 25 |
| serious Total, serious adverse events | 0 / 14 | 0 / 26 | 0 / 25 |
Outcome results
None listed