High Pain Intervention in Cesarean Sections

Wake Forest University (WFU)

Status: Completed

Conditions: Other Chronic Postoperative Pain

Treatments: Drug: Duramorph 300; Drug: Acetaminophen; Drug: Duramorph 150

Study type: Interventional

Funder types: Other

Identifiers

NCT01298778

IRB00012376

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

69 participants in 2 patient groups, including a placebo group

Standard of care

Placebo Comparator group

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.

Treatment:

Drug: Duramorph 150

Acetaminophen and increased dose of Duramorph

Active Comparator group

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.

Treatment:

Drug: Acetaminophen

Drug: Duramorph 300