High Pain Intervention in Cesarean Sections

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Other Chronic Postoperative Pain

Intervention / Treatment
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* Drug: Duramorph 150
* Drug: Acetaminophen
* Drug: Duramorph 300


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard of care<br>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<br>* Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses<br>|
| Active Comparator: Acetaminophen and increased dose of Duramorph<br>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<br>* Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses<br>Drug: Duramorph 300<br>* Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pain | resting pain, worst pain | 24 hour | 
| Analgesic Consumption | total amount of analgesic consumption | 24 hour | 
| 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 | 
| Average Pain Over 24 Hours |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain post delivery, postpartum depression, tailored pain management