Low Pain Prediction in Cesarean Section Patients

Wake Forest University (WFU)

Status and phase: Terminated; Phase 4

Conditions: Postoperative Pain Management; Scheduled Cesarean Sections; Side Effects

Treatments: Drug: duramorph; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02143141

IRB00017294

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• allergies to morphine or acetaminophen
• diagnosis of a chronic pain disorder
• weight >300 lbs
• hepatic disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups

duramorph

Active Comparator group

Description:

duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours

Treatment:

Drug: duramorph

no duramorph

Experimental group

Description:

no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively

Treatment:

Drug: placebo