The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Beth Israel Deaconess Medical Center
Sponsor:
Information provided by (Responsible Party):
Phillip Hess, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01146457
First received: June 14, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Labor Pain
Drug: Morphine
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Rate of Breakthrough pain [ Time Frame: Average time to delivery ] [ Designated as safety issue: No ]
    Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the time period 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 is used as the primary outcome.


Secondary Outcome Measures:
  • Postpartum pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Saline
Saline Control
Other Name: Saline added to solution
Active Comparator: Morphine 25 Drug: Morphine
Active dosage
Other Name: Dose of morphine added to solution
Active Comparator: Morphine 50 Drug: Morphine
Active dosage
Other Name: Dose of morphine added to solution
Active Comparator: Morphine 75 Drug: Morphine
Active dosage
Other Name: Dose of morphine added to solution
Active Comparator: Morphine 100 Drug: Morphine
Active dosage
Other Name: Dose of morphine added to solution

Detailed Description:

Regional anesthesia techniques such as combined spinal epidural (CSE) analgesia are very effective for the management of intrapartum pain. The advantages of these techniques are that they are safe when properly conducted and that they provide excellent analgesia while allowing the patient to remain awake and participate in the labor and delivery. The risks of maternal aspiration and fetal drug depression associated with general anesthesia are minimized. Finally, the effective analgesia associated with regional techniques blunt the hemodynamic effects caused by painful contractions and reduce maternal catecholamines, resulting in increased placental perfusion.1

Opioids in combination with local anesthetics in the spinal space provide effective pain relief during labor with minimal side effects. The advantages of spinal opioid administration include lack of motor blockade and faster onset of analgesia.2 In addition, since the opiate receptors are in the spinal space, a smaller amount of opioid can be used to provide excellent pain relief while minimizing the side effects. At Beth Israel Deaconess Medical Center (BIDMC), the obstetric anesthesiology group uses a standard spinal dosing for CSE during labor which includes: 1 ml of 0.25% bupivicaine with 12.5 mcg of fentanyl.

Yeh and colleagues have found that morphine 150 mcg added to the fentanyl-bupivicaine spinal injection can prolong the duration of spinal analgesia but was associated with increased side effects. 3 The side effect profile of spinal narcotics include: nausea, vomiting, pruritus, and urinary retention. Although these side effects for the most part can be easily treated, they can be bothersome to the post partum patient. In a previous study performed from our institution, the addition of 100 mcg of morphine to spinal bupivicaine and fentanyl reduced the rate of breakthrough pain during labor analgesia and prolonged the time to first request for supplementation. Overall, it was found that the incidence of side effects was low but the group that received the spinal morphine did have more nausea and vomiting compared with the placebo group. 4

In this current investigation, we would like to assess whether an even smaller dose of spinal morphine would provide an effective, pain free recovery from vaginal delivery while decreasing the incidence of side effects, specifically nausea and vomiting. We would like to perform a formal dose response study to identify the ideal dose of intrathecal morphine that would not compromise the pain relief during labor while minimizing the side effects.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146457

Contacts
Contact: Philip Hess, MD 6176673112 phess@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Philip E Hess, MD    617-667-3353    phess@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Philip E Hess, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Phillip Hess, Chief of Obstetric Anesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01146457     History of Changes
Other Study ID Numbers: 2009-P-000197
Study First Received: June 14, 2010
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Obstetric anesthesia
labor analgesia
morphine
epidural analgesia

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 28, 2014