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In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later. The investigators believe those at risk for severe acute post-partum pain can be identified, and medical interventions can be tailored to manage postoperative pain more effectively.
This study is randomizing patients into 2 different groups and seeing if by altering our pain management with this group of patients their acute 24 hour evoked pain is less than anticipated; and the incidence of persistent pain and depression when contacted 2 months after delivery is decreased. This study is designed to see if these additional interventions would prove effective for patients at risk of having high pain level after cesarean surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Placebo Comparator | Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. |
|
| Acetaminophen and increased dose of Duramorph | Active Comparator | Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duramorph 150 | Drug | Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Acute Pain | to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable. | 24 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Persistent Pain | to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery. | 2 months |
| Pain |
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus | side effects-percentage of subjects requiring treatment | 24 hours |
| Emetic Symptoms | side effect potential with the increased dose of duramorph-percentage experiencing such symptoms |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter H. Pan, MD, MSEE | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forsyth Medical Center-Sara Lee Center for Women's Health | Winston-Salem | North Carolina | 27103 | United States |
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Participants were approached during the pre-anesthesia evaluation regarding their interest in the study. Once consent was signed, subjects completed their pre-surgery questionnaires. On the day of surgery, I/E criteria were re-reviewed for confirmed enrollment for study.A total of 74 were consented with 69 randomized, with 60 completing the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses |
| FG001 | Acetaminophen and Increased Dose of Duramorph | Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | years of age at time of consent |
| 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 | Severity of Acute Pain | to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable. | Posted | Mean | Standard Deviation | mm | 24 hour |
|
Participants were followed at 24 hours postoperatively and for 8 weeks postpartum.
Outcome measures for incidence of pruritis and emetic symptoms have been reported in the arms section as those were expected outcomes that could be measurable.
These are all anticipated events for such surgery patients and do not exceed the normal frequency threshold; therefore they were not considered adverse events.
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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 | Standard of Care | Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Booth | Wake Forest School of Medicine | 336-718-8278 | jbooth@wakehealth.edu |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Acetaminophen | Drug | Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses |
|
| Duramorph 300 | Drug | Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses |
|
resting pain, worst pain
| 24 hour |
| Analgesic Consumption | total amount of analgesic consumption | 24 hour |
| Incidence of Depression | to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery. | 2 months |
| Average Pain Over 24 Hours | 24 hours |
| 24hours |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| not meet inclusion/exclusion criteria |
|
| Acetaminophen and Increased Dose of Duramorph |
Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height-cm | Mean | Standard Deviation | cm |
|
| Weight-kg | Mean | Standard Deviation | kg |
|
| Gestational Age-weeks | Mean | Standard Deviation | weeks gestation |
|
| Parity | Mean | Full Range | number previous deliveries |
|
| Previous Cesarean Section | Number of subjects out of the total subjects per group that had experienced a previous CS Delivery | Count of Participants | Participants |
|
| ASA class | American Society Anesthesiology classification of 1 (healthy), 2, 3, or 4 (most severely ill) | Median | Full Range | units on a scale |
|
Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
|
|
|
| Secondary | Incidence of Persistent Pain | to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery. | Posted | Number | percentage of participants | 2 months |
|
|
|
| Secondary | Pain | resting pain, worst pain | Posted | Median | Inter-Quartile Range | units on a scale, 0 -none, 100-worst | 24 hour |
|
|
|
| Secondary | Analgesic Consumption | total amount of analgesic consumption | Posted | Median | Inter-Quartile Range | mg | 24 hour |
|
|
|
| Secondary | Incidence of Depression | to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery. | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Secondary | Average Pain Over 24 Hours | VAS pain score of 0=no pain at all up to 100 being worst pain imaginable. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
| Other Pre-specified | Pruritus | side effects-percentage of subjects requiring treatment | percentage of patients with pruritis requiring treatment. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Other Pre-specified | Emetic Symptoms | side effect potential with the increased dose of duramorph-percentage experiencing such symptoms | percentage of patients reporting emetic symptoms requiring treatment | Posted | Count of Participants | Participants | 24hours |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Acetaminophen and Increased Dose of Duramorph | Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses | 0 | 30 | 0 | 30 |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| Aniline Compounds |
| D000588 | Amines |