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High Pain Intervention in Cesarean Sections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01298778
First Posted: February 18, 2011
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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 150 Drug: Acetaminophen Drug: Duramorph 300

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 University Health Sciences:

Primary Outcome Measures:
  • Severity of Acute Pain [ Time Frame: 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:
  • Incidence of Persistent Pain [ Time Frame: 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.

  • Pain [ Time Frame: 24 hour ]
    resting pain, worst pain

  • Analgesic Consumption [ Time Frame: 24 hour ]
    total amount of analgesic consumption

  • Incidence of Depression [ Time Frame: 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.

  • Average Pain Over 24 Hours [ Time Frame: 24 hours ]

Other Outcome Measures:
  • Pruritus [ Time Frame: 24 hours ]
    side effects-percentage of subjects requiring treatment

  • Emetic Symptoms [ Time Frame: 24hours ]
    side effect potential with the increased dose of duramorph-percentage experiencing such symptoms


Enrollment: 69
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 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University Health Sciences
Investigators
Principal Investigator: Peter H. Pan, MD, MSEE Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01298778     History of Changes
Other Study ID Numbers: IRB 00012376
First Submitted: February 17, 2011
First Posted: February 18, 2011
Results First Submitted: August 31, 2015
Results First Posted: June 9, 2017
Last Update Posted: November 8, 2017
Last Verified: May 2017

Keywords provided by Wake Forest University Health Sciences:
chronic pain post delivery
postpartum depression
tailored pain management

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