High Pain Intervention in Cesarean Sections

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-07-31

Brief Summary

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In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later. The investigators believe those at risk for severe acute post-partum pain can be identified, and medical interventions can be tailored to manage postoperative pain more effectively.

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Detailed Description

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This study is randomizing patients into 2 different groups and seeing if by altering our pain management with this group of patients their acute 24 hour evoked pain is less than anticipated; and the incidence of persistent pain and depression when contacted 2 months after delivery is decreased. This study is designed to see if these additional interventions would prove effective for patients at risk of having high pain level after cesarean surgery.

Conditions

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Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard of care

Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.

Group Type PLACEBO_COMPARATOR

Duramorph 150

Intervention Type DRUG

Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses

Acetaminophen and increased dose of Duramorph

Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses

Duramorph 300

Intervention Type DRUG

Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses

Interventions

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Duramorph 150

Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses

Intervention Type DRUG

Acetaminophen

Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses

Intervention Type DRUG

Duramorph 300

Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* elective cesarean section
* age \>/= 18 years old
* not allergic proposed study medications
* predicted to experience high pain postop based on preoperative evaluation