Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03470675
• Other study ID #: STU00206016
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 27, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression, Postpartum
• Pain
• Postpartum Depression

Intervention

Drug:
• Epidural saline + IV saline
Sterile saline injection in the epidural catheter and in the intravenous catheter
• Epidural morphine 3 mg + IV saline
Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
• 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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal quality of life	Patient Reported Outcome Measurement Information System (PROMIS) 29 questionnaire. 28 question survey	3 months after delivery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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