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The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia

Primary Purpose

Labor Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morphine
Saline
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Obstetric anesthesia, labor analgesia, morphine, epidural analgesia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Morphine 25

Morphine 50

Morphine 75

Morphine 100

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2010
Last Updated
March 14, 2017
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01146457
Brief Title
The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia
Official Title
The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Obstetric anesthesia, labor analgesia, morphine, epidural analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Morphine 25
Arm Type
Active Comparator
Arm Title
Morphine 50
Arm Type
Active Comparator
Arm Title
Morphine 75
Arm Type
Active Comparator
Arm Title
Morphine 100
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Dose of morphine added to solution
Intervention Description
Active dosage
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Saline added to solution
Intervention Description
Saline Control
Primary Outcome Measure Information:
Title
Rate of Breakthrough Pain
Description
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.
Time Frame
Participants were followed for the duration of delivery, an average of 7 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip E Hess, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia

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