PremixedNCT06820203
Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section
A study testing Fentanyl and Bupivacaine in people with Premixed and Sequential, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to distinguish between premixed, sequential, and manually mixed administration of intrathecal fentanyl and bupivacaine in cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premixed, Sequential, Manually Mixed
- What is being tested?
- Fentanyl and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2025to 15 Jul 2025
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 40 years.
- Height between 150 to175 cm.
- Body mass index (BMI) between 18.5 and 30 kg/m2.
- American Society of Anesthesiology (ASA) physical status II.
- Scheduled for cesarean section under spinal anesthesia.
Who cannot join
- Pre-operation hypotension and bradycardia.
- Preeclampsia.
- Multiple pregnancy and macrosomia.
- Complete or partial failed spinal.
- Patients with skin infections at the site of injection.
- Patients with coagulation disorders.
- Patients with spinal deformities.
- Patients having regional nerve block other than spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section: A Randomized Controlled Study
This study aims to distinguish between premixed, sequential, and manually mixed administration of intrathecal fentanyl and bupivacaine in cesarean section.
Read the detailed description
Cesarean section (CS) is a lifesaving procedure when there is both maternal and fetal problems. The rate of CS increases dramatically from time to time. Regional anesthesia techniques are highly preferred for CS compared to general anesthesia.
Coadministration of intrathecal opioids and local anesthetics (LAs) have been found to produce a potent intra and postoperative analgesic synergism without further depression of efferent sympathetic activity, hence results in less adverse hemodynamic effects, even with sub-therapeutic doses of LAs.
Fentanyl has been considered the intrathecal LAs adjuvant of choice owing to its potency, fast onset and short duration of action, and lower incidence of respiratory depression.
- Conditions
- Premixed, Sequential, Manually Mixed, Intrathecal, Fentanyl, Bupivacaine
- Being tested
- Fentanyl and Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl and BupivacaineDrug
Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe.
Fentanyl and BupivacaineDrug
Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.
Fentanyl and BupivacaineDrug
Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe.
| Study group | Role | What they receive |
|---|---|---|
| Premixed group | Experimental | Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe. Receives: Drug: Fentanyl and Bupivacaine |
| Sequential group | Experimental | Patients will receive intrathecal fentanyl and bupivacaine in separate syringes. Receives: Drug: Fentanyl and Bupivacaine |
| Manual mixed group | Active comparator | Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe. Receives: Drug: Fentanyl and Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from end of surgery to first dose of pethidine administrated).
Measured: 24 hours postoperatively
Secondary outcomes (7)
Total analgesic consumption
The total amount of analgesic the patient will be given within 24 h after spinal anesthesia
Measured: 24 hours postoperatively
Degree of pain
The degree of pain will be assessed using the numerical rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 2, 4, 6, 8, 12, 18, and 24h postoperatively.
Measured: 24 hours postoperatively
Onset of motor block
onset of motor block (defined as the time from giving spinal anesthesia until a modified Bromage score of 3 was reached). The modified Bromage scale [0: No motor block, 1: Unable to raise an extended leg (able to flex the knee), 2: Unable to flex the knee (able to move the foot only), 3: Unable to flex the ankle (unable to move the foot or knee)]
Measured: Intraoperatively
Duration of motor block
Duration of motor block (defined as the time from the onset of motor blockade until complete recovery, indicated by a Bromage score of 0) will be recorded
Measured: Intraoperatively
Onset of sensory block
Onset of sensory block (time elapsed from the end of spinal injection to absence of pinprick sensation at T10 dermatome).
Measured: Intraoperatively
Duration of sensory block
Duration of sensory block (The time till achieving T10 sensory level in addition to the maximum block height) will be noted and recorded.
Measured: Intraoperatively
Incidence of complications
Incidence of complications such as bradycardia, hypotension, nausea, Pruritus, shivering, respiratory depression, or any other complication will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start12 Feb 2025
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PremixedStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820203
- Sponsor's protocol ID
- 36264PR1048/1/25
- Status last verified
- Jul 2025
- First submitted
- 6 Feb 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06820203
- Acronym / sponsor ID
- 36264PR1048/1/25
- Conditions
- Premixed, Sequential, Manually Mixed, Intrathecal, Fentanyl, Bupivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 11 Feb 2025 (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.
This study aims to distinguish between premixed, sequential, and manually mixed administration of intrathecal fentanyl and bupivacaine in cesarean section.
Detailed description
Cesarean section (CS) is a lifesaving procedure when there is both maternal and fetal problems. The rate of CS increases dramatically from time to time. Regional anesthesia techniques are highly preferred for CS compared to general anesthesia.
Coadministration of intrathecal opioids and local anesthetics (LAs) have been found to produce a potent intra and postoperative analgesic synergism without further depression of efferent sympathetic activity, hence results in less adverse hemodynamic effects, even with sub-therapeutic doses of LAs.
Fentanyl has been considered the intrathecal LAs adjuvant of choice owing to its potency, fast onset and short duration of action, and lower incidence of respiratory depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Premixed group | Experimental | Drug: Fentanyl and BupivacainePatients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe. |
| Sequential group | Experimental | Drug: Fentanyl and BupivacainePatients will receive intrathecal fentanyl and bupivacaine in separate syringes. |
| Manual mixed group | Active comparator | Drug: Fentanyl and BupivacainePatients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age from 18 to 40 years.
- Height between 150 to175 cm.
- Body mass index (BMI) between 18.5 and 30 kg/m2.
- American Society of Anesthesiology (ASA) physical status II.
- Scheduled for cesarean section under spinal anesthesia.
Key exclusion criteria (8 listed)
- Pre-operation hypotension and bradycardia.
- Preeclampsia.
- Multiple pregnancy and macrosomia.
- Complete or partial failed spinal.
- Patients with skin infections at the site of injection.
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 and BupivacainePatients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe. | Drug | Premixed group |
| Fentanyl and BupivacainePatients will receive intrathecal fentanyl and bupivacaine in separate syringes. | Drug | Sequential group |
| Fentanyl and BupivacainePatients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe. | Drug | Manual mixed group |
Primary outcome
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Time to the first request for the rescue analgesia (time from end of surgery to first dose of pethidine administrated).
7 secondary outcomes
Total analgesic consumption
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Onset of motor block
Time frame: Intraoperatively
Duration of motor block
Time frame: Intraoperatively
Onset of sensory block
Time frame: Intraoperatively
Duration of sensory block
Time frame: Intraoperatively
Incidence of complications
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Bupivacaine in people with Premixed and Sequential, run by Tanta University at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 25 Jul 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the 1st rescue analgesia (time frame: 24 hours postoperatively). 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 25 Jul 2025.