Low Pain Prediction in Cesarean Section Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Eliminating Long Acting Spinal Narcotic Use and Its Associated Side Effects for Those Who do Not Need it After Cesarean Delivery

Conditions
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Scheduled Cesarean Sections, Postoperative Pain Management, Side Effects

Intervention / Treatment
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* Drug: duramorph
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: duramorph<br>duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours | Drug: duramorph<br>* 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.<br>* Other names: duramorph versus placebo;|
| Experimental: no duramorph<br>no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively | Drug: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Itching | 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. | 24 hours | 
| Nausea/Vomiting | 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. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, narcotic side effects