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High Pain Intervention in Cesarean Sections

Primary Purpose

Other Chronic Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duramorph 150
Acetaminophen
Duramorph 300
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Other Chronic Postoperative Pain focused on measuring chronic pain post delivery, postpartum depression, tailored pain management

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Standard of care

Acetaminophen and increased dose of Duramorph

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Pain
resting pain, worst pain
Analgesic Consumption
total amount of analgesic consumption
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.
Average Pain Over 24 Hours

Full Information

First Posted
February 17, 2011
Last Updated
August 9, 2018
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01298778
Brief Title
High Pain Intervention in Cesarean Sections
Official Title
Improving Pain Relief For Those Who Need It Most After Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Chronic Postoperative Pain
Keywords
chronic pain post delivery, postpartum depression, tailored pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Acetaminophen and increased dose of Duramorph
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Duramorph 150
Intervention Description
Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Intervention Type
Drug
Intervention Name(s)
Duramorph 300
Intervention Description
Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Primary Outcome Measure Information:
Title
Severity of Acute Pain
Description
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 Outcome Measure Information:
Title
Incidence of Persistent Pain
Description
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
Title
Pain
Description
resting pain, worst pain
Time Frame
24 hour
Title
Analgesic Consumption
Description
total amount of analgesic consumption
Time Frame
24 hour
Title
Incidence of Depression
Description
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
Title
Average Pain Over 24 Hours
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Pruritus
Description
side effects-percentage of subjects requiring treatment
Time Frame
24 hours
Title
Emetic Symptoms
Description
side effect potential with the increased dose of duramorph-percentage experiencing such symptoms
Time Frame
24hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H. Pan, MD, MSEE
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Forsyth Medical Center-Sara Lee Center for Women's Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States

12. IPD Sharing Statement

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High Pain Intervention in Cesarean Sections

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