High Pain Intervention in Cesarean Sections

Wake Forest University Health Sciences69 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Interventions

Duramorph 150DRUG

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

AcetaminophenDRUG

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

Duramorph 300DRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * elective cesarean section * age \>/= 18 years old * not allergic proposed study medications * predicted to experience high pain postop based on preoperative evaluation Exclusion Criteria: * allergy to study medications * known hepatic disease * weight \> 300 lbs

Locations (1)

Forsyth Medical Center-Sara Lee Center for Women's Health

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Severity of Acute Pain

to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable.

Time frame: 24 hour

Secondary Outcomes

Incidence of Persistent Pain

to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery.

Time frame: 2 months

Pain

resting pain, worst pain

Time frame: 24 hour

Analgesic Consumption

total amount of analgesic consumption

Time frame: 24 hour

Incidence of Depression

to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery.

Time frame: 2 months

Average Pain Over 24 Hours

Time frame: 24 hours

Data from ClinicalTrials.gov

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