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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural saline + IV saline | Placebo Comparator | Sterile saline via the epidural catheter. Sterile saline via intravenous catheter. |
|
| Epidural morphine 3 mg + IV saline | Active Comparator | 3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter. |
|
| Epidural morphine 3 mg + IV ketamine 0.3 mg/kg | Active Comparator | 3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural saline + IV saline | Drug | Sterile saline injection in the epidural catheter and in the intravenous catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 week after vaginal delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Perineal Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feyce Peralta, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26637088 | Background | 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. | |
| 15507941 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epidural Saline + IV Saline | Sterile saline via the epidural catheter. Sterile saline via intravenous catheter. Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter |
| FG001 | Epidural Morphine 3 mg + IV Saline | 3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter. Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter |
| FG002 | 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. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epidural Saline + IV Saline | Sterile saline via the epidural catheter. Sterile saline via intravenous catheter. Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter |
| BG001 | Epidural Morphine 3 mg + IV Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 (good)and 10 highest pain (poor). | Epidural saline + IV saline group 1 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up | Posted | Mean | Inter-Quartile Range | score on a scale | 1 week after vaginal delivery |
|
48 Hours after delivery of baby.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epidural Saline + IV Saline | Sterile saline via the epidural catheter. Sterile saline via intravenous catheter. Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
This project enrollment was closed early because of loss of funding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul C. Fitzgerald, RN, BSN, MS | Northwestern University | 312-695-1064 | p-fitzgerald2@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2019 | Mar 11, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 30, 2020 | Mar 11, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011644 | Puerperal Disorders |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Epidural morphine 3 mg + IV saline | Drug | Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter |
|
| Epidural morphine 3 mg + IV ketamine 0.3 mg/kg | Drug | Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter |
|
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 |
| 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). | 1 week after delivery |
| 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 |
| 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. | 1 week after delivery |
| 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 |
| 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 |
| 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 |
| 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. | 6 weeks after delivery |
| 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 |
| 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 |
| 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. | 3 months after delivery |
| 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. | 3 months after delivery |
| 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. | 3 month |
| 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. | 3 month |
| 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. | 3 month |
| 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. | 3 month |
| 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. | 3 month |
| 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. | 3 month |
| 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. | 3 month |
| 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). | 1 year after delivery |
| Background |
| 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. |
| 27222452 | Background | 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. |
| 21224020 | Background | 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. |
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter. Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter |
| BG002 | 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. 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 |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Current Smoker | Count of Participants | Participants |
|
| Gravida | Number times pregnant | Number | number of participants |
|
| Para | Parity (para) indicates the number of times a woman has given birth to a fetus (alive or stillborn) | Number | number of participants |
|
| Gestational Age (weeks) | Mean | Standard Deviation | Weeks |
|
| Labor Type | Count of Participants | Participants |
|
| Labor Type | Count of Participants | Participants |
|
| Rupture of Membranes | Number | participants |
|
| Fetal Presentation | Count of Participants | Participants |
|
| Prostaglandin Cervical Ripening | Count of Participants | Participants |
|
| Oxytocin Augmentation | Count of Participants | Participants |
|
| 1st Stage of Labor (minutes) | Mean | Inter-Quartile Range | Minutes |
|
| 2nd stage of labor (minutes) | Count of Participants | Participants |
|
| Delivery Mode | Count of Participants | Participants |
|
| Operative Type | Count of Participants | Participants |
|
| Degree Perineal Laceration | Count of Participants | Participants |
|
| Suture Repair Style | Count of Participants | Participants |
|
| Fetal Weight | Fetal weight in grams. | Mean | Standard Deviation | Grams |
|
| Plan to Breastfeed | Count of Participants | Participants |
|
| NRS Pain Score at Study Drug Administration | The Numeric Pain Rating Scale (NRS) is a 0-10 point, self-reported tool for assessing pain intensity, where 0 represents "no pain" and 10 represents "the worst pain imaginable", obtained before the study drug administration. | Mean | Inter-Quartile Range | Score on Scale |
|
| ACRI Questionnaire | Addiction Research Center Inventory (ARCI) modified 10 question (yes-no answer) self-report questionnaire used to assess effects of psychoactive drugs.Low score 0 no activity-10 high activity to drug. | Mean | Inter-Quartile Range | score on scale |
|
| Epidural Morphine 3 mg + IV Saline |
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter. Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter |
| OG002 | 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. 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 |
|
|
| 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. | Epidural Morphine 3 mg + saline group 3 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up | Posted | Mean | Full Range | score on a scale | 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. | Epidural saline + IV saline group 1 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up | Posted | Mean | Full Range | score on a scale | 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 (poor) to 95 high maternal infant attachment (good). | Epidural saline + IV saline group 1 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up | Posted | Mean | Full Range | Score on a scale | 1 week after delivery |
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|
| 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. | Epidural saline + IV saline group 1 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up | Posted | Mean | Full Range | score on a scale | 1 week after delivery |
|
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|
| Secondary | 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. | Epidural saline + IV saline group 1 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up | Posted | Mean | Full Range | score on a scale | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | score on a scale | 6 weeks 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | score on a scale | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | Score on a scale | 6 weeks after delivery |
|
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| Secondary | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | score on a scale | 6 weeks after delivery |
|
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| 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 4 lost to follow up | Posted | Mean | Full Range | score on a scale | 3 months 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 4 lost to follow up | Posted | Mean | Full Range | Scores on a scale | 3 months after delivery |
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| Secondary | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 4 lost to follow up | Posted | Mean | Full Range | Score on scale 2 low 36 high | 3 months after delivery |
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| Secondary | 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. | Epidural saline + IV saline group 4 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | score on a scale | 3 months after delivery |
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| Secondary | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | T score | 3 month |
|
|
|
| Secondary | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | T score | 3 month |
|
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| Secondary | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | T score | 3 month |
|
|
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| Secondary | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | T score | 3 month |
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|
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| Secondary | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | T score | 3 month |
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|
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| Secondary | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | T score | 3 month |
|
|
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| Secondary | 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. | Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up | Posted | Mean | Full Range | T score | 3 month |
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|
|
| Secondary | 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). | Epidural saline + IV saline group 6 lost to follow up Epidural Morphine 3 mg + saline group 9 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 4 lost to follow up | Posted | Mean | Full Range | score on a scale | 1 year after delivery |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 4 |
| 14 |
| EG001 | Epidural Morphine 3 mg + IV Saline | 3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter. Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter | 0 | 26 | 0 | 26 | 14 | 26 |
| EG002 | 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. 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 | 0 | 25 | 0 | 25 | 13 | 25 |
| Pruritus | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Fever | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Back Ache | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hives | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Wound Problems | General disorders | MedDRA (12.0) | Systematic Assessment | Perineal tear suture repair. |
|
Not provided
Not provided
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D017670 |
| Sodium Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |