Obstetric PainMoFeNCT06355271
Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery
A study testing Fentanyl 1, Fentanyl2 and Fentanyl 3 in people with Obstetric Pain, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Pain
- What is being tested?
- Fentanyl 1, Fentanyl2 and Fentanyl 3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Jun 2024to 31 Dec 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 year of age
- height over 160 cm
- American Society Anesthesiologists physical status I and II
- term singleton parturients
- scheduled for elective cesarean delivery during spinal anesthesia at Ospedale Regionale Bellinzona Valli
Who cannot join
- patients with inability to consent
- patient refusal
- contraindication to spinal anesthesia (eg, hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis)
- emergency cesarean delivery
- preeclampsia/eclampsia
- allergy to drugs used in the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Ospedale Regionale di Bellinzona, San Giovanni
Bellinzona
Roberto Dossi, MD, Roberto.Dossi@eoc.ch
About this study
Official title: Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery Adding Different Doses of Intrathecal Fentanyl to Spinal Anesthesia With Bupivacaine and Intrathecal Morphine. A Single Center, Randomized, Multiple Blinded, Controlled Trial
Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery
Read the detailed description
In the study intervention group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 %, morphine sulfate 100 mcg and an added randomized dose of 10 or 20 mcg IT fentanyl. The spinal anesthetic will be administered with a 27 gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. The fentanyl doses will be prepared by an anesthesiologist who will not be involved in the study or the patient's treatment. For 24 hours following surgery, each patient would receive intravenous patient-controlled morphine analgesia. In the control group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 % and morphine sulfate 100 mcg. The spinal anesthetic will be administered with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. For 24 hours following surgery, each patient would receive intravenous patient- controlled morphine analgesia.
- Conditions
- Obstetric Pain
- Being tested
- Fentanyl 1, Fentanyl2, Fentanyl 3
- Keywords
- Cesarean section, Fentanyl, Functional Recovery
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl 1Procedure or surgery
Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and no fentanyl
Fentanyl2Procedure or surgery
Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 10 mcg of of fentanyl
Fentanyl 3Procedure or surgery
Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 20 mcg of fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Spinal anesthesia with no fentanyl Receives: Procedure: Fentanyl 1 |
| Experimental 1 | Experimental | Spinal anesthesia with 10 mcg of fentanyl Receives: Procedure: Fentanyl2 |
| Experimental 2 | Experimental | Spinal anesthesia with 20 mcg of fentanyl Receives: Procedure: Fentanyl 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Controlled Analgesia morphine consumption
Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours
Measured: Day 1 after cesarean section
obstetric quality of recovery score
obstetric quality of recovery score (ObsQoR-11)
Measured: Day 1 after cesarean section
Secondary outcomes (7)
Visual Analogue Scale
pain scores after surgery (Visual Analogue Scale -VAS- where 0 is the minimum value and 10 is the maximum value. The higher is the score the worse is pain control) at 4, 12 e 24 h.
Measured: Day 1 after cesarean section
pruritus
Intraoperative and postoperative pruritus (rating 0-10 The higher is the score the worse is pruritus)
Measured: Day 1 after cesarean section (and day 0 for intraoperative pruritus)
nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity
intraoperative and postoperative nausea and vomiting
Measured: Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting)
intraoperative hypotension
intraoperative hypotension
Measured: during the cesarean section
intraoperative opioids
intraoperative opioids in morphine equivalents
Measured: during the cesarean section
satisfaction rate
satisfaction rate (0-100, where 0 is the minimum value and 100 is the maximum value. The higher is the score the better is the satisfaction rate)
Measured: Day 1 after cesarean section
intraoperative pain
intraoperative pain Visual Analogue Scale (Visual Analogue Scale -VAS- where 0 is the minimum value and 10 is the maximum value. The higher is the score the worse is pain control)
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start12 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric 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
- Model description
- Single center, multiple-blind, prospective, randomized, controlled trial in 3 parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dossi Roberto, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355271
- Sponsor's protocol ID
- 2024-00019
- Acronym
- MoFe
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2024
- Last updated
- 16 Mar 2026
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery Adding Different Doses of Intrathecal Fentanyl to Spinal Anesthesia With Bupivacaine and Intrathecal Morphine. A Single Center, Randomized, Multiple Blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT06355271
- Acronym / sponsor ID
- MoFe / 2024-00019
- Conditions
- Obstetric Pain
- Keywords
- Cesarean section, Fentanyl, Functional Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Apr 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.
Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery
Detailed description
In the study intervention group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 %, morphine sulfate 100 mcg and an added randomized dose of 10 or 20 mcg IT fentanyl. The spinal anesthetic will be administered with a 27 gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. The fentanyl doses will be prepared by an anesthesiologist who will not be involved in the study or the patient's treatment. For 24 hours following surgery, each patient would receive intravenous patient-controlled morphine analgesia. In the control group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 % and morphine sulfate 100 mcg. The spinal anesthetic will be administered with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. For 24 hours following surgery, each patient would receive intravenous patient- controlled morphine analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Single center, multiple-blind, prospective, randomized, controlled trial in 3 parallel groups
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Fentanyl 1Spinal anesthesia with no fentanyl |
| Experimental 1 | Experimental | Procedure: Fentanyl2Spinal anesthesia with 10 mcg of fentanyl |
| Experimental 2 | Experimental | Procedure: Fentanyl 3Spinal anesthesia with 20 mcg of fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients over 18 year of age
- height over 160 cm
- American Society Anesthesiologists physical status I and II
- term singleton parturients
- scheduled for elective cesarean delivery during spinal anesthesia at Ospedale Regionale Bellinzona Valli
Key exclusion criteria (6 listed)
- patients with inability to consent
- patient refusal
- contraindication to spinal anesthesia (eg, hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis)
- emergency cesarean delivery
- preeclampsia/eclampsia
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 1Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and no fentanyl | Procedure or surgery | Control |
| Fentanyl2Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 10 mcg of of fentanyl | Procedure or surgery | Experimental 1 |
| Fentanyl 3Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 20 mcg of fentanyl | Procedure or surgery | Experimental 2 |
Primary outcome
Patient Controlled Analgesia morphine consumption
Time frame: Day 1 after cesarean section
Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours
obstetric quality of recovery score
Time frame: Day 1 after cesarean section
obstetric quality of recovery score (ObsQoR-11)
7 secondary outcomes
Visual Analogue Scale
Time frame: Day 1 after cesarean section
pruritus
Time frame: Day 1 after cesarean section (and day 0 for intraoperative pruritus)
nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity
Time frame: Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting)
intraoperative hypotension
Time frame: during the cesarean section
intraoperative opioids
Time frame: during the cesarean section
satisfaction rate
Time frame: Day 1 after cesarean section
intraoperative pain
Time frame: during the surgery
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 16 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl 1, Fentanyl2 and Fentanyl 3 in people with Obstetric Pain, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
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 5 inclusion and 6 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 16 Mar 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 Switzerland. 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. 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 Roberto Dossi (0918119341, roberto.dossi@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Controlled Analgesia morphine consumption (time frame: Day 1 after cesarean section). The study lists 2 primary outcomes in all. 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 16 Mar 2026.