Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
Primary Purpose
Pain, Postpartum Depression
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Epidural saline + IV saline
Epidural morphine 3 mg + IV saline
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Sponsored by
About this trial
This is an interventional prevention trial for Pain
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
Sites / Locations
- Northwestern UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Epidural saline + IV saline
Epidural morphine 3 mg + IV saline
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Arm Description
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Maternal quality of life
Patient Reported Outcome Measurement Information System (PROMIS) 29 questionnaire. 28 question survey
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.
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)
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)
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)
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)
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)
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)
Full Information
NCT ID
NCT03470675
First Posted
March 2, 2018
Last Updated
January 18, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT03470675
Brief Title
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
Official Title
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postpartum Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epidural saline + IV saline
Arm Type
Placebo Comparator
Arm Description
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Arm Title
Epidural morphine 3 mg + IV saline
Arm Type
Active Comparator
Arm Description
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Arm Title
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Arm Type
Active Comparator
Arm Description
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Intervention Type
Drug
Intervention Name(s)
Epidural saline + IV saline
Intervention Description
Sterile saline injection in the epidural catheter and in the intravenous catheter
Intervention Type
Drug
Intervention Name(s)
Epidural morphine 3 mg + IV saline
Intervention Description
Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
Intervention Type
Drug
Intervention Name(s)
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Intervention Description
Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
Primary Outcome Measure Information:
Title
Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
Description
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.
Time Frame
1 week after vaginal delivery
Secondary Outcome Measure Information:
Title
Perineal Pain
Description
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.
Time Frame
Day 1 after delivery
Title
Perineal Pain
Description
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.
Time Frame
1 week after delivery
Title
Perineal Pain
Description
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.
Time Frame
6 weeks after delivery
Title
Perineal Pain
Description
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.
Time Frame
3 months after delivery
Title
Perineal Pain
Description
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.
Time Frame
6 months after delivery
Title
Perineal Pain
Description
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.
Time Frame
1 year after delivery
Title
Presence of postpartum depression
Description
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.
Time Frame
1 week after delivery
Title
Presence of postpartum depression
Description
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.
Time Frame
6 weeks after delivery
Title
Assessment of maternal-infant bonding
Description
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.
Time Frame
1 week after delivery
Title
Assessment of maternal-infant bonding
Description
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.
Time Frame
6 weeks after delivery
Title
Assessment of maternal-infant bonding
Description
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.
Time Frame
3 months after delivery
Title
Medoc Pathway Device Score
Description
Medoc Pathway Device (Durham NC) pain sensory results using VRS (verbal rating scale) 0 = no pain and 10 = worst pain imaginable
Time Frame
1 week post delivery
Title
Maternal quality of life
Description
Patient Reported Outcome Measurement Information System (PROMIS) 29 questionnaire. 28 question survey
Time Frame
3 months after delivery
Title
Female sexual function
Description
Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function and 36 high sexual function.
Time Frame
3 months after delivery
Title
Promis 29 profile
Description
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)
Time Frame
6 week
Title
Promis 29 profile
Description
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)
Time Frame
3 month
Title
Brief Pain Inventory (Short Form) Modified
Description
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)
Time Frame
1 day after delivery
Title
Brief Pain Inventory (Short Form) Modified
Description
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)
Time Frame
1 week after delivery
Title
Brief Pain Inventory (Short Form) Modified
Description
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)
Time Frame
6 weeks after delivery
Title
Brief Pain Inventory (Short Form) Modified
Description
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)
Time Frame
3 months after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feyce M Peralta, MD
Phone
312-472-3585
Email
feyce.peralta@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feyce Peralta, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feyce M Peralta, MD
Phone
312-472-3585
Email
feyce.peralta@northwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26637088
Citation
Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0. Erratum In: J Obstet Gynaecol Can. 2016 Apr;38(4):421. J Obstet Gynaecol Can. 2016 Apr;38(4):421.
Results Reference
background
PubMed Identifier
15507941
Citation
Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
Results Reference
background
PubMed Identifier
27222452
Citation
Chang SR, Chen KH, Lee CN, Shyu MK, Lin MI, Lin WA. Relationships between perineal pain and postpartum depressive symptoms: A prospective cohort study. Int J Nurs Stud. 2016 Jul;59:68-78. doi: 10.1016/j.ijnurstu.2016.02.012. Epub 2016 Feb 26.
Results Reference
background
PubMed Identifier
21224020
Citation
Bauchat JR, Higgins N, Wojciechowski KG, McCarthy RJ, Toledo P, Wong CA. Low-dose ketamine with multimodal postcesarean delivery analgesia: a randomized controlled trial. Int J Obstet Anesth. 2011 Jan;20(1):3-9. doi: 10.1016/j.ijoa.2010.10.002.
Results Reference
background
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Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
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