High Pain Intervention in Cesarean Sections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Peter H. Pan, M.D., MSEE, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01298778
First received: February 17, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Other Chronic Postoperative Pain
Drug: Duramorph
Drug: Acetaminophen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Pain Relief For Those Who Need It Most After Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Severity of acute pain [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • Incidence of depression and Persistent Pain [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression and persistent pain up to 2 months post delivery. <These are the 2 Main Secondary outcome measures>

  • Pain [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]
    resting pain, average pain, worst pain

  • analgesic consumption [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]
    total amount of analgesic consumption


Other Outcome Measures:
  • pruritus [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    side effects

  • emetic symptoms [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]
    side effects

  • respiratory depression [ Time Frame: 24hr ] [ Designated as safety issue: Yes ]
    side effect


Enrollment: 60
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298778

Locations
United States, North Carolina
Forsyth Medical Center-Sara Lee Center for Women's Health
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Peter H. Pan, MD, MSEE Wake Forest Baptist Health
  More Information

No publications provided

Responsible Party: Dr. Peter H. Pan, M.D., MSEE, Anesthesiologist, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01298778     History of Changes
Other Study ID Numbers: IRB 00012376
Study First Received: February 17, 2011
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
chronic pain post delivery
postpartum depression
tailored pain management

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Morphine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on September 16, 2014