The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia

Labor Pain Clinical Trial

Official title:

The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01146457
• Other study ID #: 2009-P-000197
• Status: Terminated
• Phase: N/A
• First received: June 14, 2010
• Last updated: January 28, 2015
• Start date: July 2010
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Morphine
Active dosage
• Saline
Saline Control

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Breakthrough pain	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.	Average time to delivery	No
Secondary	Postpartum pain		24 hours	No