The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia

NCT01146457 | Terminated Results

• 1 other identifier: 2009P000197
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the ideal dosage of intrathecal morphine for intra and post partum analgesia, while minimizing the side effect profile.

Conditions

Labor Pain

Keywords

Obstetric anesthesia; labor analgesia; morphine; epidural analgesia

Outcome Measures

Primary Outcomes (1)

• Rate of Breakthrough Pain

  Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the number of hours of labor. Time measured from placement of the neuraxial anesthetic, until delivery of the neonate. Because duration of labor is different for all patients, the rate of breakthrough pain per hour is used as the primary outcome.

  Participants were followed for the duration of delivery, an average of 7 hours

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Drug: Saline

Morphine 25

ACTIVE COMPARATOR

Drug: Morphine

Morphine 50

ACTIVE COMPARATOR

Drug: Morphine

Morphine 75

ACTIVE COMPARATOR

Drug: Morphine

Morphine 100

ACTIVE COMPARATOR

Drug: Morphine

Interventions

Morphine DRUG

Active dosage

Also known as: Dose of morphine added to solution

Morphine 100; Morphine 25; Morphine 50; Morphine 75

Saline DRUG

Saline Control

Also known as: Saline added to solution

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• singleton pregnancy,
• at least 36 weeks gestational age,
• active labor (≤ 5 cm dilation) requesting neuraxial analgesia,
• ASA I or II,
• not currently taking pain medications.

You may not qualify if:

• multiple gestation,
• preterm labor,
• systemic opioids in the past 4 hours,
• chronic pain syndromes,
• chronic opioid use,
• contraindications to regional anesthesia,
• allergies to opioids,
• significant co existing medical problems,
• severe pregnancy induced hypertension,
• sedatives,
• magnesium therapy,
• diabetes type 1.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Morphine; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Philip Hess
• Organization: BIDMC

phess@bidmc.harvard.edu

617-667-3353

Study Officials

• Philip E Hess, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: Chief of Obstetric Anesthesia

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 17, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 25, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)