MedPath

Intrathecal Hydromorphone for Pain Control After Cesarean Section

Phase 2
Completed
Conditions
Cesarean Section
Pain
Interventions
Registration Number
NCT02096003
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Brief Summary

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. The investigators 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intrathecal hydromorphoneIntrathecal hydromorphone50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
Intrathecal morphineIntrathecal morphine0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections
Primary Outcome Measures
NameTimeMethod
Post Operative Fentanyl PCA Consumptionat 24 hours

Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.

Secondary Outcome Measures
NameTimeMethod
Patient Satisfaction Scoreat 24 hours

Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction

Symptom Scale for Two Specific Side Effects of Nausea and Pruritusup to 24 hours

Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms.

Time to Initial PCA Useup to 24 hours

When does the patient need to use the PCA for the first time? This will be used to assess when morphine and hydromorphone first begin to provide analgesia.

Pain Scoreat 24 hours

Assess pain scores on a scale of 1-5, with higher score indicating more pain.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai

🇺🇸

New York, New York, United States

© Copyright 2025. All Rights Reserved by MedPath