Intraoperative PainPhase 4NCT06570343
Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery
A Phase 4 study testing Fentanyl-Morphine and Morphine in people with Intraoperative Pain, run by Seoul National University Hospital.
Trial summary
Pregnant women scheduled for elective cesarean sections under spinal anesthesia are randomly assigned to two groups: 1) the Fentanyl-Morphine (FM) group, and 2) the Morphine (M) group. Read more about this study
- Who is it for?
- Ages 19 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Pain
- What is being tested?
- Fentanyl-Morphine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2024to 25 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parturients of gestational age > 37 weeks, scheduled for cesarean section under spinal anesthesia
Who cannot join
- Contraindication to spinal anesthesia
- Any sign of onset of labor
- Emergency cesarean section
- Body weight < 40 kg or > 120 kg
- Height < 140 cm or > 190 cm
- Severe underlying cardiovascular disease
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- Known fetal anomaly
- Preeclampsia
- History of hypersensitivity to fentanyl or morphine
- Chronic opioid use
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery: a Randomized Clinical Trial
Pregnant women scheduled for elective cesarean sections under spinal anesthesia are randomly assigned to two groups: 1) the Fentanyl-Morphine (FM) group, and 2) the Morphine (M) group. In addition to 11.5 mg of bupivacaine, the FM group receives 15 μg of fentanyl and 50 μg of morphine intrathecally, while the M group receives 50 μg of morphine intrathecally. The incidence of intraoperative pain with a Numerical Rating Scale (NRS) score of 4 or higher is compared between the two groups to evaluate the analgesic effects of combined intrathecal fentanyl-morphine therapy versus morphine alone.
- Conditions
- Intraoperative Pain
- Being tested
- Fentanyl-Morphine, Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl-MorphineDrug
Intrathecal injection of bupivacaine, fentanyl and morphine
MorphineDrug
Intrathecal injection of bupivacaine and morphine
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl-Morphine | Experimental | Spinal anesthesia with heavy bupivacaine, fentanyl and morphine Receives: Drug: Fentanyl-Morphine |
| Morphine | Active comparator | Spinal anesthesia with heavy bupivacaine and morphine Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative pain
Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher
Measured: From first skin incision to end of surgery
Secondary outcomes (25)
Time of occurence of intraoperative pain
Time of occurence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher
Measured: From first skin incision to end of surgery
Incidence of intraoperative rescue analgesic administration
Incidence of intraoperative rescue analgesic administration
Measured: From first skin incision to end of surgery
Total amount of intraoperative opioid rescue analgesic administration
Total amount of intraoperative opioid rescue analgesic administration (morphine mg equivalent)
Measured: From first skin incision to end of surgery
Total amount of intraoperative non-opioid rescue analgesic administration
Total amount of intraoperative non-opioid rescue analgesic administration (mg)
Measured: From first skin incision to end of surgery
Intraoperative pain characteristics
Intraoperative pain characteristics
Measured: From first skin incision to end of surgery
Conversion to general anesthesia
Conversion to general anesthesia
Measured: From first skin incision to end of surgery
Preoperative anxiety
Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score)
Measured: On the day before surgery
Preoperative anxiety
Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score)
Measured: On the day of surgery
Total amount of postoperative opioid analgesic administered
Total amount of postoperative opioid analgesic administered (morphine mg equivalent)
Measured: From end of surgery to 24 hours after end of surgery
Incidence of intraoperative nausea/vomiting
Incidence of intraoperative nausea/vomiting
Measured: From induction to end of surgery
Incidence of postoperative nausea/vomiting
Incidence of postoperative nausea/vomiting
Measured: From end of surgery to 24h post-surgery
Incidence of intraoperative shivering
Incidence of intraoperative shivering
Measured: From induction to end of surgery
Incidence of intraoperative hypotension
Incidence of intraoperative hypotension (MBP<65 mmHg)
Measured: From induction to end of surgery
Incidence of intraoperative pruritus
Incidence of intraoperative pruritus
Measured: From induction to end of surgery
Incidence of postoperative pruritus
Incidence of postoperative pruritus
Measured: From end of surgery to 24h post-surgery
Immediate post-operative patient satisfaction
Immediate post-operative patient satisfaction on intraoperative analgesia
Measured: At the end of surgery
Obstetric Quality of Recovery-11K score
Obstetric Quality of Recovery-11K score
Measured: At 24 hours post-surgery
Time of first postoperative pain
Time of first postoperative pain
Measured: From end of surgery to 24 hours post-surgery
Pain score at 8 hours post-surgery
Pain score at 8 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)
Measured: at 8 hours post-surgery
Pain score at 16 hours post-surgery
Pain score at 16 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)
Measured: at 16 hours post-surgery
Pain score at 24 hours post-surgery
Pain score at 24 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)
Measured: at 24 hours post-surgery
Pain score at 2 hours post-surgery
Pain score at 2 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)
Measured: at 2 hours post-surgery
Incidence of postoperative hypotension
Incidence of postoperative hypotension (MBP\<65 mmHg)
Measured: From end of surgery to 24 hours post-surgery
Incidence of postoperative shivering
Incidence of postoperative shivering
Measured: From end of surgery to 24 hours post-surgery
24-hour post-operative patient satisfaction
24-hour post-operative patient satisfaction on postoperative analgesia
Measured: at 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start20 Sep 2024 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570343
- Sponsor's protocol ID
- 2407-091-1553
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06570343
- Acronym / sponsor ID
- 2407-091-1553
- Conditions
- Intraoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 26 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.
Pregnant women scheduled for elective cesarean sections under spinal anesthesia are randomly assigned to two groups: 1) the Fentanyl-Morphine (FM) group, and 2) the Morphine (M) group. In addition to 11.5 mg of bupivacaine, the FM group receives 15 μg of fentanyl and 50 μg of morphine intrathecally, while the M group receives 50 μg of morphine intrathecally. The incidence of intraoperative pain with a Numerical Rating Scale (NRS) score of 4 or higher is compared between the two groups to evaluate the analgesic effects of combined intrathecal fentanyl-morphine therapy versus morphine alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl-Morphine | Experimental | Drug: Fentanyl-MorphineSpinal anesthesia with heavy bupivacaine, fentanyl and morphine |
| Morphine | Active comparator | Drug: MorphineSpinal anesthesia with heavy bupivacaine and morphine |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parturients of gestational age > 37 weeks, scheduled for cesarean section under spinal anesthesia
Key exclusion criteria (10 listed)
- Contraindication to spinal anesthesia
- Any sign of onset of labor
- Emergency cesarean section
- Body weight < 40 kg or > 120 kg
- Height < 140 cm or > 190 cm
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 |
|---|---|---|
| Fentanyl-MorphineIntrathecal injection of bupivacaine, fentanyl and morphine | Drug | Fentanyl-Morphine |
| MorphineIntrathecal injection of bupivacaine and morphine | Drug | Morphine |
Primary outcome
Incidence of intraoperative pain
Time frame: From first skin incision to end of surgery
Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher
25 secondary outcomes
Time of occurence of intraoperative pain
Time frame: From first skin incision to end of surgery
Incidence of intraoperative rescue analgesic administration
Time frame: From first skin incision to end of surgery
Total amount of intraoperative opioid rescue analgesic administration
Time frame: From first skin incision to end of surgery
Total amount of intraoperative non-opioid rescue analgesic administration
Time frame: From first skin incision to end of surgery
Intraoperative pain characteristics
Time frame: From first skin incision to end of surgery
Conversion to general anesthesia
Time frame: From first skin incision to end of surgery
Preoperative anxiety
Time frame: On the day before surgery
Preoperative anxiety
Time frame: On the day of surgery
Total amount of postoperative opioid analgesic administered
Time frame: From end of surgery to 24 hours after end of surgery
Incidence of intraoperative nausea/vomiting
Time frame: From induction to end of surgery
Incidence of postoperative nausea/vomiting
Time frame: From end of surgery to 24h post-surgery
Incidence of intraoperative shivering
Time frame: From induction to end of surgery
Incidence of intraoperative hypotension
Time frame: From induction to end of surgery
Incidence of intraoperative pruritus
Time frame: From induction to end of surgery
Incidence of postoperative pruritus
Time frame: From end of surgery to 24h post-surgery
Immediate post-operative patient satisfaction
Time frame: At the end of surgery
Obstetric Quality of Recovery-11K score
Time frame: At 24 hours post-surgery
Time of first postoperative pain
Time frame: From end of surgery to 24 hours post-surgery
Pain score at 8 hours post-surgery
Time frame: at 8 hours post-surgery
Pain score at 16 hours post-surgery
Time frame: at 16 hours post-surgery
Pain score at 24 hours post-surgery
Time frame: at 24 hours post-surgery
Pain score at 2 hours post-surgery
Time frame: at 2 hours post-surgery
Incidence of postoperative hypotension
Time frame: From end of surgery to 24 hours post-surgery
Incidence of postoperative shivering
Time frame: From end of surgery to 24 hours post-surgery
24-hour post-operative patient satisfaction
Time frame: at 24 hours post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl-Morphine and Morphine in people with Intraoperative Pain, run by Seoul National University Hospital.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Tae Kim, M.D., Ph.D (+82-2-2072-2467, jintae73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative pain (time frame: From first skin incision to end of surgery). 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 Oct 2024.