Intrathecal Hydromorphone for Pain Control After Cesarean Section

Description

The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery. Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting. Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section. In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. We need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.

Study Start Date

April 2014

Estimated Completion Date

December 2016

Interventions

  • Drug: Intrathecal hydromorphone
  • Drug: Intrathecal morphine

Specialties

  • Obstetrics & Gynecology: Ob-Gyn Surgery,Pain Management
  • Pharmacy: Pain Management
  • Pain Management: Pharmacy

MeSH Terms

  • Cesarean Section
  • Intrathecal hydromorphone
  • Intrathecal morphine
  • Pain

Study ID

Mount Sinai School of Medicine -- GCO 13-1762

Status

Unknown

Trial ID

NCT02096003

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

50

Sponsor

Mount Sinai School of Medicine

Inclusion Criteria

  • Elective primary cesarean section
  • Females age 18-40

Exclusion Criteria

  • Emergency cesarean section
  • Anesthetic other than spinal
  • History of chronic pain or pre-op opioid use
  • Allergy to morphine or hydromorphone
  • BMI>40

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles Yaakov Beilin MD 212-241-7467 yakov.beilin@mountsinai.org

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