High Pain Intervention in Cesarean Sections
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Improving Pain Relief For Those Who Need It Most After Cesarean Delivery|
- Severity of acute pain [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]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)
- Incidence of depression and Persistent Pain [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression and persistent pain up to 2 months post delivery. <These are the 2 Main Secondary outcome measures>
- Pain [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]resting pain, average pain, worst pain
- analgesic consumption [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]total amount of analgesic consumption
- pruritus [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]side effects
- emetic symptoms [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]side effects
- respiratory depression [ Time Frame: 24hr ] [ Designated as safety issue: Yes ]side effect
|Study Start Date:||August 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: 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 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses
Active Comparator: 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.
Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298778
|United States, North Carolina|
|Forsyth Medical Center-Sara Lee Center for Women's Health|
|Winston-Salem, North Carolina, United States, 27103|
|Principal Investigator:||Peter H. Pan, MD, MSEE||Wake Forest Baptist Health|