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OpenTrials
Completed

NCT Number: NCT01298778

High Pain Intervention in Cesarean Sections

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.

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Key information

Conditions

Other Chronic Postoperative Pain Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Winston-Salem, North Carolina, 27103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duramorph 150

Drug

Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses

Acetaminophen

Drug

Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses

Duramorph 300

Drug

Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Pain

    Time frame: 24 hour

    resting pain, worst pain

  3. Analgesic Consumption

    Time frame: 24 hour

    total amount of analgesic consumption

  4. 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.

  5. Average Pain Over 24 Hours

    Time frame: 24 hours

Other outcomes

  1. Pruritus

    Time frame: 24 hours

    side effects-percentage of subjects requiring treatment

  2. Emetic Symptoms

    Time frame: 24hours

    side effect potential with the increased dose of duramorph-percentage experiencing such symptoms

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 18, 2011
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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