Intrathecal Hydromorphone for Pain Control After Cesarean Section

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096003
• Other study ID #: GCO 13-1762
• Status: Completed
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: May 5, 2017

Study information

• Verified date: July 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 5, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Pain

Intervention

Drug:
• Intrathecal morphine
0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.
• Intrathecal hydromorphone
50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Fentanyl PCA Consumption	Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.	at 24 hours
Secondary	Time to Initial PCA Use	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.	up to 24 hours
Secondary	Pain Score	Assess pain scores on a scale of 1-5, with higher score indicating more pain.	at 24 hours
Secondary	Patient Satisfaction Score	Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction	at 24 hours
Secondary	Symptom Scale for Two Specific Side Effects of Nausea and Pruritus	Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms.	up to 24 hours