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Completed

NCT Number: NCT02096003

Intrathecal Hydromorphone for Pain Control After Cesarean Section

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Intrathecal morphine

Drug

0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.

Other names: Duramorph

Intrathecal hydromorphone

Drug

50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.

Other names: Dilaudid

Primary outcomes

  1. Post Operative Fentanyl PCA Consumption

    Time frame: at 24 hours

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

Secondary outcomes

  1. Time to Initial PCA Use

    Time frame: up 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.

  2. Pain Score

    Time frame: at 24 hours

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

  3. Patient Satisfaction Score

    Time frame: at 24 hours

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

  4. Symptom Scale for Two Specific Side Effects of Nausea and Pruritus

    Time frame: up to 24 hours

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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Comparison of Intrathecal Hydromorphone and Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2014
Registry last updated
Aug 20, 2019

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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