Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

Study Overview
=================
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.

Official Title
-----------------
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries: A Randomized Clinical Trial

Conditions
-----------------
Pain, Postpartum Depression

Intervention / Treatment
-----------------
* Drug: Epidural saline + IV saline
* Drug: Epidural morphine 3 mg + IV saline
* Drug: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Epidural saline + IV saline<br>Sterile saline via the epidural catheter. Sterile saline via intravenous catheter. | Drug: Epidural saline + IV saline<br>* Sterile saline injection in the epidural catheter and in the intravenous catheter<br>|
| Active Comparator: Epidural morphine 3 mg + IV saline<br>3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter. | Drug: Epidural morphine 3 mg + IV saline<br>* Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter<br>|
| Active Comparator: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg<br>3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter. | Drug: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg<br>* Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries. | Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain. | 1 week after vaginal delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perineal Pain | 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. | Day 1 after delivery | 
| Perineal Pain | Perineal pain day 7 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. | 1 week after delivery | 
| Perineal Pain | Perineal pain 6 weeks 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. | 6 weeks after delivery | 
| Perineal Pain | Perineal pain 3 months 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. | 3 months after delivery | 
| Perineal Pain | Perineal pain 6 months after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain. | 6 months after delivery | 
| Perineal Pain | Perineal pain 1 year after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain. | 1 year after delivery | 
| Presence of postpartum depression | 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. | 1 week after delivery | 
| Presence of postpartum depression | Presence of postpartum depression 6 weeks 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. | 6 weeks after delivery | 
| Assessment of maternal-infant bonding | 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 to 95 high maternal infant attachment. | 1 week after delivery | 
| Assessment of maternal-infant bonding | 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 to 95 high maternal infant attachment. | 6 weeks after delivery | 
| Assessment of maternal-infant bonding | 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 to 95 high maternal infant attachment. | 3 months after delivery | 
| Medoc Pathway Device Score | Medoc Pathway Device (Durham NC) pain sensory results using VRS (verbal rating scale) 0 = no pain and 10 = worst pain imaginable | 1 week post delivery | 
| Maternal quality of life | Patient Reported Outcome Measurement Information System (PROMIS) 29 questionnaire. 28 question survey | 3 months after delivery | 
| Female sexual function | Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function and 36 high sexual function. | 3 months after delivery | 
| Promis 29 profile | 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) | 6 week | 
| Promis 29 profile | 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) | 3 month | 
| Brief Pain Inventory (Short Form) Modified | 7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief%. 0= no relief (poor) and 100% complete relief (good) | 1 day after delivery | 
| Brief Pain Inventory (Short Form) Modified | 7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief%. 0= no relief (poor) and 100% complete relief (good) | 1 week after delivery | 
| Brief Pain Inventory (Short Form) Modified | 7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief%. 0= no relief (poor) and 100% complete relief (good) | 6 weeks after delivery | 
| Brief Pain Inventory (Short Form) Modified | 7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief %. 0= no relief (poor) and 100% complete relief (good) | 3 months after delivery |