High Pain Intervention in Cesarean Sections

Other Chronic Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298778
• Other study ID #: IRB00012376
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Other Chronic Postoperative Pain
• Pain, Postoperative

Intervention

Drug:
• Duramorph 150
Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses
• Acetaminophen
Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
• Duramorph 300
Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses

Locations

Country	Name	City	State
United States	Forsyth Medical Center-Sara Lee Center for Women's Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pruritus	side effects-percentage of subjects requiring treatment	24 hours
Other	Emetic Symptoms	side effect potential with the increased dose of duramorph-percentage experiencing such symptoms	24hours
Primary	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	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
Secondary	Pain	resting pain, worst pain	24 hour
Secondary	Analgesic Consumption	total amount of analgesic consumption	24 hour
Secondary	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
Secondary	Average Pain Over 24 Hours		24 hours