Labor PainNCT06572241
Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural
A study testing Intrathecal morphine in people with Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Intrathecal morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Less than or equal to 6 cm cervical dilation during the last vaginal examination.
Who cannot join
- Patients who are expected to be discharged within 24 hours of delivery.
- Patients with chronic pain conditions, opioid use disorder, pre-gestational diabetes, obstructive sleep apnea, morbid obesity (BMI >40 kg/m2), or fetal abnormalities.
- 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
- Participants will be excluded from further analysis if labour lasts less than 2 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Naveed Siddiqui, MD, 416-586-5270, naveed.siddiqui@uhn.ca
Ronald George, MD
About this study
Official title: Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural: a Double-blinded Randomized Control Trial
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.
Read the detailed description
The addition of morphine to a combination of bupivacaine and lipophilic opioids (fentanyl) for the spinal component of CSE for labor analgesia has been shown to increase the duration of analgesia. A meta-analysis by Al-Kazwini and coworkers suggests a possible beneficial prolonging effect of adding morphine to spinal analgesia, however, the authors concluded that more adequately powered randomized controlled trials (RCTs) are required to determine the benefits and harms of intrathecal morphine (ITM).
This prolonged duration of action of ITM may reduce the need for frequent top-ups, which could alleviate nursing and anesthesiologist workload and enhance maternal satisfaction. An RCT conducted by Vasudevan and coworkers has concluded that the addition of 100 mcg ITM along with bupivacaine and fentanyl reduced the incidence of breakthrough pain in labor. Another dose-finding study comparing 50 and 100 mcg of ITM as a component of CSE labor analgesia concluded that 100 mcg of ITM significantly lowers the local anesthetic consumption and shorter duration of the first stage of labor without any significant difference in adverse effects. The RCT by Vasudevan et al. had a small sample size, enrolled mixed parity patients, and utilized continuous infusion for labor analgesia maintenance.
Hence, the investigators plan to conduct adequately powered RCT enrolling only primigravidae patients, which tend to have more prolonged labor than multiparous and programmed intermittent epidural bolus (PIEB) with patient-controlled epidural analgesia (PCEA) will be used, which is a more contemporary labor maintenance technique.
- Conditions
- Labor Pain
- Being tested
- Intrathecal morphine, Saline solution (placebo)
- Keywords
- combined spinal epidural, CSE, intrathecal morphine
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphineDrug
Also called Morphine
morphine 100 mcg, included in the intrathecal component of combined spinal epidural (CSE).
Saline solution (placebo)Other
Also called saline
normal saline 0.2 ml added to the intrathecal component of combined spinal epidural (CSE).
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | 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). Receives: Drug: Intrathecal morphine |
| Placebo | Placebo comparator | 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). Receives: Other: Saline solution (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of breakthrough pain: questionnaire
The rate of breakthrough pain is defined as the ratio of the number of episodes of breakthrough pain during labour analgesia and the duration of epidural analgesia. An episode of breakthrough pain during labour analgesia was defined as subjective discomfort due to pain or pressure increasing during a contraction (rated as NRS ≥3/10), which was successfully treated with the manual administration of supplemental medications.
Measured: 24 hours
Secondary outcomes (17)
Time to first episode of breakthrough pain in minutes
The amount of time in minutes to the first recorded episode of breakthrough pain, defined as subjective discomfort due to pain or pressure increasing during a contraction (rated as NRS ≥3/10), which was successfully treated with the manual administration of supplemental medications.
Measured: 24 hours
Epidural medication consumption (milliliters)
The overall consumption of epidural medication throughout labour, in milliliters.
Measured: 24 hours
Epidural pump settings: questionnaire
Any adjustments made to the programmed intermittent bolus settings of the epidural pump will be recorded.
Measured: 24 hours
Presence of fetal heart rate anomalies: questionnaire
The presence of any fetal heart rate anomalies will be recorded
Measured: 24 hours
Presence of Cesarean delivery: questionnaire
The presence of Cesarean delivery will be recorded
Measured: 24 hours
Analgesic consumption post-delivery: questionnaire
Presence of analgesic consumption post-delivery will be recorded.
Measured: 24 hours
Presence of pruritis: questionnaire
The presence of pruritis (yes or no) will be recorded.
Measured: 24 hours
Presence of nausea: questionnaire
The presence of nausea(yes or no) will be recorded.
Measured: 24 hours
Presence of vomiting: questionnaire
The presence of vomiting(yes or no) will be recorded.
Measured: 24 hours
Presence of sedation: questionnaire
The presence of sedation(yes or no) will be recorded.
Measured: 24 hours
Presence of respiratory depression: questionnaire
The presence of respiratory depression(yes or no) will be recorded.
Measured: 24 hours
Apgar score at 1 minute
Apgar score recorded by the respiratory therapist, nurse or midwife at 1 minute of life.
Measured: 1 minute
Apgar score at 5 minutes
Apgar score recorded by the respiratory therapist, nurse or midwife at 5 minutes of life.
Measured: 5 minutes
Umbilical artery pH
Lab results for umbilical artery pH
Measured: 24 hours
Umbilical vein pH
Lab results for umbilical vein pH
Measured: 24 hours
Satisfaction: questionnaire
Post-delivery, patients will be asked how satisfied they were with their labour analgesia from 0-10, where 0 is no pain and 10 is the worst pain imaginable.
Measured: 24 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
ObsQoR-10 score at 24 hours. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start20 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naveed Siddiqui, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572241
- Sponsor's protocol ID
- 24-06
- Status last verified
- Feb 2026
- First submitted
- 23 Aug 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural: a Double-blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06572241
- Acronym / sponsor ID
- 24-06
- Conditions
- Labor Pain
- Keywords
- combined spinal epidural, CSE, intrathecal morphine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The addition of morphine to a combination of bupivacaine and lipophilic opioids (fentanyl) for the spinal component of CSE for labor analgesia has been shown to increase the duration of analgesia. A meta-analysis by Al-Kazwini and coworkers suggests a possible beneficial prolonging effect of adding morphine to spinal analgesia, however, the authors concluded that more adequately powered randomized controlled trials (RCTs) are required to determine the benefits and harms of intrathecal morphine (ITM).
This prolonged duration of action of ITM may reduce the need for frequent top-ups, which could alleviate nursing and anesthesiologist workload and enhance maternal satisfaction. An RCT conducted by Vasudevan and coworkers has concluded that the addition of 100 mcg ITM along with bupivacaine and fentanyl reduced the incidence of breakthrough pain in labor. Another dose-finding study comparing 50 and 100 mcg of ITM as a component of CSE labor analgesia concluded that 100 mcg of ITM significantly lowers the local anesthetic consumption and shorter duration of the first stage of labor without any significant difference in adverse effects. The RCT by Vasudevan et al. had a small sample size, enrolled mixed parity patients, and utilized continuous infusion for labor analgesia maintenance.
Hence, the investigators plan to conduct adequately powered RCT enrolling only primigravidae patients, which tend to have more prolonged labor than multiparous and programmed intermittent epidural bolus (PIEB) with patient-controlled epidural analgesia (PCEA) will be used, which is a more contemporary labor maintenance technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: Intrathecal morphine0.6 ml of 0.25% bupivacaine, fentanyl 10 mcg with morphine 100 mcg (total volume 1 ml) as intrathecal component of combined spinal epidural (CSE). |
| Placebo | Placebo comparator | Other: Saline solution (placebo)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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
- Less than or equal to 6 cm cervical dilation during the last vaginal examination.
Key exclusion criteria (5 listed)
- Patients who are expected to be discharged within 24 hours of delivery.
- Patients with chronic pain conditions, opioid use disorder, pre-gestational diabetes, obstructive sleep apnea, morbid obesity (BMI >40 kg/m2), or fetal abnormalities.
- 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
- Participants will be excluded from further analysis if labour lasts less than 2 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal morphineAlso: Morphinemorphine 100 mcg, included in the intrathecal component of combined spinal epidural (CSE). | Drug | Morphine |
| Saline solution (placebo)Also: salinenormal saline 0.2 ml added to the intrathecal component of combined spinal epidural (CSE). | Other | Placebo |
Primary outcome
Presence of breakthrough pain: questionnaire
Time frame: 24 hours
The rate of breakthrough pain is defined as the ratio of the number of episodes of breakthrough pain during labour analgesia and the duration of epidural analgesia. An episode of breakthrough pain during labour analgesia was defined as subjective discomfort due to pain or pressure increasing during a contraction (rated as NRS ≥3/10), which was successfully treated with the manual administration of supplemental medications.
17 secondary outcomes
Time to first episode of breakthrough pain in minutes
Time frame: 24 hours
Epidural medication consumption (milliliters)
Time frame: 24 hours
Epidural pump settings: questionnaire
Time frame: 24 hours
Presence of fetal heart rate anomalies: questionnaire
Time frame: 24 hours
Presence of Cesarean delivery: questionnaire
Time frame: 24 hours
Analgesic consumption post-delivery: questionnaire
Time frame: 24 hours
Presence of pruritis: questionnaire
Time frame: 24 hours
Presence of nausea: questionnaire
Time frame: 24 hours
Presence of vomiting: questionnaire
Time frame: 24 hours
Presence of sedation: questionnaire
Time frame: 24 hours
Presence of respiratory depression: questionnaire
Time frame: 24 hours
Apgar score at 1 minute
Time frame: 1 minute
Apgar score at 5 minutes
Time frame: 5 minutes
Umbilical artery pH
Time frame: 24 hours
Umbilical vein pH
Time frame: 24 hours
Satisfaction: questionnaire
Time frame: 24 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naveed Siddiqui, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal morphine in people with Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naveed Siddiqui, MD (416-586-5270, naveed.siddiqui@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of breakthrough pain: questionnaire (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.