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Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470675
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Feyce M. Peralta, Northwestern University

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

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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, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470675


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

Locations
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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
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Principal Investigator: Feyce Peralta, MD Northwestern University
Publications:
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Responsible Party: Feyce M. Peralta, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03470675    
Other Study ID Numbers: STU00206016
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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