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PainPhase 4NCT03470675

Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

A Phase 4 study testing Epidural saline + IV saline, Epidural morphine 3 mg + IV saline and Epidural morphine 3 mg + IV ketamine 0.3 mg/kg in people with Pain and Postpartum Depression, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pain, Postpartum Depression
What is being tested?
Epidural saline + IV saline, Epidural morphine 3 mg + IV saline and Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
1 siteUnited States
Study dates
27 Jun 2018to 20 Jun 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

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

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.

Being tested
Epidural saline + IV saline, Epidural morphine 3 mg + IV saline, Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Medical subject headings
Pain, Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural saline + IV salineDrug

    Sterile saline injection in the epidural catheter and in the intravenous catheter

  • Epidural morphine 3 mg + IV salineDrug

    Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter

  • Epidural morphine 3 mg + IV ketamine 0.3 mg/kgDrug

    Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter

Study groups in NCT03470675
Study groupRoleWhat they receive
Epidural saline + IV salinePlacebo comparatorSterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Receives: Drug: Epidural saline + IV saline
Epidural morphine 3 mg + IV salineActive comparator3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Receives: Drug: Epidural morphine 3 mg + IV saline
Epidural morphine 3 mg + IV ketamine 0.3 mg/kgActive comparator3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Receives: Drug: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (good)and 10 highest pain (poor).

    Measured: 1 week after vaginal delivery

Secondary outcomes (21)
  1. 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.

    Measured: Day 1 after delivery

  2. 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.

    Measured: 1 week after delivery

  3. 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 (poor) to 95 high maternal infant attachment (good).

    Measured: 1 week after delivery

  4. 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.

    Measured: 1 week after delivery

  5. Brief Pain Inventory (BPI-ST Short Form) Current Pain

    Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.

    Measured: 1 week after delivery

  6. 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.

    Measured: 6 weeks after delivery

  7. 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.

    Measured: 6 weeks after delivery

  8. 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.

    Measured: 6 weeks after delivery

  9. Brief Pain Inventory (BPI-ST Short Form) Current Pain

    Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.

    Measured: 6 weeks after delivery

  10. 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.

    Measured: 3 months after delivery

  11. 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.

    Measured: 3 months after delivery

  12. Female Sexual Function

    Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function to 36 high sexual function.

    Measured: 3 months after delivery

  13. Brief Pain Inventory (BPI-ST Short Form) Current Pain

    Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.

    Measured: 3 months after delivery

  14. Promis 29 Profile (Physical Function Question Only)

    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.

    Measured: 3 month

  15. Promis 29 Profile (Anxiety Function Question Only)

    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.

    Measured: 3 month

  16. Promis 29 Profile (Depressive Symptoms Question Only)

    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.

    Measured: 3 month

  17. Promis 29 Profile (Fatigue Question Only)

    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.

    Measured: 3 month

  18. Promis 29 Profile (Sleep Disturbance Question Only)

    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.

    Measured: 3 month

  19. Promis 29 Profile (Social Function Question Only)

    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.

    Measured: 3 month

  20. Promis 29 Profile (Pain Interference Question Only)

    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.

    Measured: 3 month

  21. Perineal Pain

    Perineal pain 1 year after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good) and 10 highest pain (poor).

    Measured: 1 year after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2018
  2. Study start27 Jun 2018
  3. Primary completion20 May 2024
  4. Study completion20 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03470675
Sponsor's protocol ID
STU00206016
Status last verified
Apr 2026
First submitted
2 Mar 2018
Last updated
24 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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. doi: 10.1016/s1701-2163(16)30081-0.

    PubMed 26637088
  • 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.

    PubMed 15507941
  • 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.

    PubMed 27222452
  • 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.

    PubMed 21224020

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Epidural saline + IV saline, Epidural morphine 3 mg + IV saline and Epidural morphine 3 mg + IV ketamine 0.3 mg/kg in people with Pain and Postpartum Depression, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries. (time frame: 1 week after vaginal delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03470675, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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