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Opioid

Intrathecal Morphine for Labor Pain

N/A

Recruiting

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

Less than or equal to 6 cm cervical dilation during the last vaginal examination

Must not have

Patients who have intramuscular morphine within 12 hours or fentanyl >200 mcg in the preceding 4 hours

Participants will be excluded from further analysis in case of spinal analgesic failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Summary

This trial aims to determine if adding morphine to the spinal component of combined spinal epidural (CSE) can reduce breakthrough pain during labor. Neuraxial analgesia, which includes lum

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

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I am 18 or older, pregnant for the first time with one baby, and at least 37 weeks along.

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My last cervical check showed dilation of 6 cm or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken morphine or fentanyl recently for pain.

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My spinal pain treatment has not failed.

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I have chronic pain, opioid use disorder, diabetes before pregnancy, sleep apnea, severe obesity, or my baby has abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

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

+14 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).

0 / 5Eligibility criteria met