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Opioid

Morphine for Labor Pain

N/A
Waitlist Available
Led By Naveed Siddiqui, MD
Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Adult (≥18 years) term primiparous (≥37 weeks) patients with live singleton pregnancy
* Patients who request labour analgesia and do not have any contraindications for neuraxial analgesia.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Summary

Neuraxial analgesia has shown to be the gold standard for effective labor pain relief, offering numerous benefits including enhanced pain control and maternal satisfaction. The methods to achieve neuraxial analgesia include lumbar epidural (LE), and combined spinal epidural (CSE). While LE may not consistently provide optimal pain relief, leading to frequent maternal requests for supplemental analgesics, CSE presents a promising advancement. This is due to the rapid onset of pain relief from intrathecal components, complemented by the longer-lasting effects of epidural medications. Intrathecal drugs have demonstrated the ability to offer more symmetrical blockades compared to epidurally administered medications. Nonetheless, some clinicians remain cautious about CSE due to the potential for increased pain when transitioning from spinal to less effective epidural analgesia. Long-acting opioids like morphine in the intrathecal space may mitigate this problem by providing transitional analgesia to the laboring parturient. The primary aim of this randomized controlled trial is to provide evidence of whether the addition of 100 mcg of morphine in the intrathecal (spinal) component of CSE reduces the rate of breakthrough pain during labor.

Who is the study for?
This trial is for women in labor who need pain relief. They should not have any health conditions that would make an epidural risky, such as bleeding disorders or infection at the injection site.
What is being tested?
The study tests if adding a small dose of morphine to the spinal part of an epidural (CSE) can better prevent breakthrough pain during labor compared to using saline solution (placebo). It's a double-blinded study, so neither patients nor doctors know who gets morphine.
What are the potential side effects?
Possible side effects include itching, nausea, respiratory depression (slow breathing), and delayed onset of pain after initial relief. These are common with opioids like morphine but will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Presence of breakthrough pain: questionnaire
Secondary study objectives
Analgesic consumption post-delivery: questionnaire
Apgar score at 1 minute
Apgar score at 5 minutes
+13 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MorphineActive Control1 Intervention
0.6 ml of 0.25% bupivacaine, fentanyl 10 mcg with morphine 100 mcg (total volume 1 ml) as intrathecal component of combined spinal epidural (CSE).
Group II: PlaceboPlacebo Group1 Intervention
0.6 ml of 0.25% bupivacaine, fentanyl 10 mcg with normal saline 0.2 ml (total volume 1 ml) as intrathecal component of combined spinal epidural (CSE).

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Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
128 Previous Clinical Trials
11,243 Total Patients Enrolled
19 Trials studying Labor Pain
1,132 Patients Enrolled for Labor Pain
Naveed Siddiqui, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
7 Previous Clinical Trials
573 Total Patients Enrolled
~121 spots leftby Sep 2025