High Pain Intervention in Cesarean Sections

Not Applicable

Completed

• Conditions: Other Chronic Postoperative Pain
• Interventions: Drug: Duramorph 150; Drug: Acetaminophen; Drug: Duramorph 300

• Registration Number: NCT01298778
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2015-08-31
• Results First Submitted QC: 2017-05-10
• Results First Posted: 2017-06-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen and increased dose of Duramorph	Duramorph 300	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.
Standard of care	Duramorph 150	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.
Acetaminophen and increased dose of Duramorph	Acetaminophen	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.

Primary Outcome Measures

Name	Time	Method
Severity of Acute Pain	24 hour	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.

Secondary Outcome Measures

Name	Time	Method
Analgesic Consumption	24 hour	total amount of analgesic consumption
Pain	24 hour	resting pain, worst pain
Average Pain Over 24 Hours	24 hours
Incidence of Persistent Pain	2 months	to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery.
Incidence of Depression	2 months	to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery.

Trial Locations

Locations (1)

Forsyth Medical Center-Sara Lee Center for Women's Health; 🇺🇸 Winston-Salem, North Carolina, United States