Trials / Terminated
TerminatedNCT02143141
Low Pain Prediction in Cesarean Section Patients
Eliminating Long Acting Spinal Narcotic Use and Its Associated Side Effects for Those Who do Not Need it After Cesarean Delivery
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | duramorph | duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. |
| DRUG | placebo | placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2014-08-01
- Completion
- 2014-08-01
- First posted
- 2014-05-20
- Last updated
- 2018-09-10
- Results posted
- 2017-09-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02143141. Inclusion in this directory is not an endorsement.