Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

• ClinicalTrials.gov Identifier: NCT03470675
• Recruitment Status: Recruiting
• First Posted: March 20, 2018
• Last Update Posted: January 12, 2022
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Feyce M. Peralta, MD, MS, Northwestern University

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.

Condition or disease	Intervention/treatment	Phase
Pain; Postpartum Depression	Drug: Epidural saline + IV saline; Drug: Epidural morphine 3 mg + IV saline; Drug: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries: A Randomized Clinical Trial
• Actual Study Start Date: June 27, 2018
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: April 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Epidural saline + IV saline; Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.	Drug: Epidural saline + IV saline; Sterile saline injection in the epidural catheter and in the intravenous catheter
Active Comparator: Epidural morphine 3 mg + IV saline; 3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.	Drug: Epidural morphine 3 mg + IV saline; Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
Active Comparator: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg; 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; Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter

Outcome Measures

Primary Outcome Measures :

1. Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries. [ Time Frame: 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 and 10 highest pain.

Secondary Outcome Measures :

1. Perineal Pain [ Time Frame: 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.
2. Perineal Pain [ Time Frame: 1 week after delivery ]
   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.
3. Perineal Pain [ Time Frame: 6 weeks after delivery ]
   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.
4. Perineal Pain [ Time Frame: 3 months after delivery ]
   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.
5. Perineal Pain [ Time Frame: 6 months after delivery ]
   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. Perineal Pain [ Time Frame: 1 year after delivery ]
   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.
7. Presence of postpartum depression [ Time Frame: 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.
8. Presence of postpartum depression [ Time Frame: 6 weeks after delivery ]
   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.
9. Assessment of maternal-infant bonding [ Time Frame: 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 to 95 high maternal infant attachment.
10. Assessment of maternal-infant bonding [ Time Frame: 6 weeks 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 to 95 high maternal infant attachment.
11. Assessment of maternal-infant bonding [ Time Frame: 3 months 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 to 95 high maternal infant attachment.
12. Medoc Pathway Device Score [ Time Frame: 1 week post delivery ]
    Medoc Pathway Device (Durham NC) pain sensory results using VRS (verbal rating scale) 0 = no pain and 10 = worst pain imaginable
13. Maternal quality of life [ Time Frame: 3 months after delivery ]
    Patient Reported Outcome Measurement Information System (PROMIS) 29 questionnaire. 28 question survey
14. Female sexual function [ Time Frame: 3 months after delivery ]
    Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function and 36 high sexual function.
15. Promis 29 profile [ Time Frame: 6 week ]
    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)
16. Promis 29 profile [ Time Frame: 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)
17. Brief Pain Inventory (Short Form) Modified [ Time Frame: 1 day after delivery ]
    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)
18. Brief Pain Inventory (Short Form) Modified [ Time Frame: 1 week after delivery ]
    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)
19. Brief Pain Inventory (Short Form) Modified [ Time Frame: 6 weeks after delivery ]
    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)
20. Brief Pain Inventory (Short Form) Modified [ Time Frame: 3 months after delivery ]
    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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Feyce M Peralta, MD; 312-472-3585; feyce.peralta@northwestern.edu

Locations

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Contact: Feyce M Peralta, MD 312-472-3585 feyce.peralta@northwestern.edu

Sponsors and Collaborators

Northwestern University

Investigators

• Principal Investigator: Feyce Peralta, MD; Northwestern University

More Information

Publications:

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. Erratum in: J Obstet Gynaecol Can. 2016 Apr;38(4):421. J Obstet Gynaecol Can. 2016 Apr;38(4):421.

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.

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.

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.

• Responsible Party: Feyce M. Peralta, MD, MS, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT03470675
• Other Study ID Numbers: STU00206016
• First Posted: March 20, 2018
• Last Update Posted: January 12, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Depression, Postpartum; Puerperal Disorders; Pregnancy Complications; Depressive Disorder; Mood Disorders; Mental Disorders; Morphine; Ketamine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action