MedPath

Low Pain Prediction in Cesarean Section Patients

Phase 4
Terminated
Conditions
Scheduled Cesarean Sections
Postoperative Pain Management
Side 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
no duramorphplacebono duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively
duramorphduramorphduramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours
Primary Outcome Measures
NameTimeMethod
Pain24 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
NameTimeMethod
Itching24 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/Vomiting24 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

© Copyright 2025. All Rights Reserved by MedPath