Low Pain Prediction in Cesarean Section Patients
- Conditions
- Scheduled Cesarean SectionsPostoperative Pain ManagementSide Effects
- Interventions
- Drug: placebo
- Registration Number
- NCT02143141
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
The investigators are attempting to see if eliminating the amount of long acting spinal narcotic during cesarean section delivery will demonstrate pain scores with movement when evaluated 24 hours postoperatively as those that receive the standard dosage of spinal narcotic when combined with oral acetaminophen or placebo. The investigators also are evaluating if there are decreased side effects related to decreased narcotic usage.
- Detailed Description
Subjects are randomized on the morning of surgery to receive a standard dose of spinal narcotic or to receive no long acting spinal narcotic. The subjects may or may not also receive acetaminophen orally postoperatively. Pain scores are done on postoperative day one as well as evaluation of potential narcotic side effects such as nausea/vomiting, itching, and sedation.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 13
- anticipated pain level estimated to be in the lowest 20th percentile (calculated <34.3 utilizing our standard preoperative questionnaire)
- age >/= 18
- not allergic to any study medications to be utilized in this study
- singleton pregnancy
- allergies to morphine or acetaminophen
- diagnosis of a chronic pain disorder
- weight >300 lbs
- hepatic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description no duramorph placebo no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively duramorph duramorph duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours
- Primary Outcome Measures
Name Time Method Pain 24 hours Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain.
- Secondary Outcome Measures
Name Time Method Itching 24 hours The itching assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no itching to 100 indicating the most severe itching.
Nausea/Vomiting 24 hours The nausea/vomiting assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no nausea/vomiting to 100 indicating the most severe nausea/vomiting.
Trial Locations
- Locations (1)
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States