Intrathecal Hydromorphone for Pain Control After Cesarean Section

NCT02096003 | Completed Phase 2 Results DMC

• 1 other identifier: GCO 13-1762
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Cesarean Section

Keywords

Intrathecal hydromorphone; Intrathecal morphine; Primary cesarean section; Analgesia

Outcome Measures

Primary Outcomes (1)

• Post Operative Fentanyl PCA Consumption

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

  at 24 hours

Secondary Outcomes (4)

• Time to Initial PCA Use

  up to 24 hours

• Pain Score

  at 24 hours

• Patient Satisfaction Score

  at 24 hours

• Symptom Scale for Two Specific Side Effects of Nausea and Pruritus

  up to 24 hours

Study Arms (2)

Intrathecal morphine

ACTIVE COMPARATOR

0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections

Drug: Intrathecal morphine

Intrathecal hydromorphone

EXPERIMENTAL

50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.

Drug: Intrathecal hydromorphone

Interventions

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.

Also known as: Duramorph

Intrathecal morphine

Intrathecal hydromorphone DRUG

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

Also known as: Dilaudid

Intrathecal hydromorphone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elective primary cesarean section
• Females age 18-40

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Morphine; Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Yaakov Beilin
• Organization: Icahn School of Medicine at Mount Sinai

yaakov.beilin@mountsinai.org

212-241-7467

Study Officials

• Yaakov Beilin, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: May 1, 2014
• Primary Completion: May 5, 2017
• Study Completion: May 5, 2017
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-07

Locations

US (1)