High Pain Intervention in Cesarean Sections

Improving Pain Relief For Those Who Need It Most After Cesarean Delivery

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.

Study Overview

• Status: Completed
• Conditions: Other Chronic Postoperative Pain
• Intervention / Treatment: Drug: Duramorph 150; Drug: Acetaminophen; Drug: Duramorph 300

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center-Sara Lee Center for Women's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: Duramorph 150; Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses
Active Comparator: 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.	Drug: Acetaminophen; Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses; Drug: Duramorph 300; Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months
Pain	resting pain, worst pain	24 hour
Analgesic Consumption	total amount of analgesic consumption	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.	2 months
Average Pain Over 24 Hours		24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus	side effects-percentage of subjects requiring treatment	24 hours
Emetic Symptoms	side effect potential with the increased dose of duramorph-percentage experiencing such symptoms	24hours

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Peter H. Pan, MD, MSEE, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: postpartum depression; chronic pain post delivery; tailored pain management
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Morphine
• Other Study ID Numbers: IRB00012376

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No