Fast Track SurgeryPhase 4NCT07262398
Unilateral Intrathecal Bupivacaine Versus Prilocaine on Postoperative Spontaneous Voiding
A Phase 4 study testing Prilocaine and Bupivacain in people with Fast Track Surgery, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Background: In the context of day-case surgery, the optimal spinal anesthetic should give immediate and effective anesthesia for an appropriate period, followed by rapid regression of sensory and motor blocking, rapid bladder voiding, and little residual effects to allow for early ambulation and discharge. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Fast Track Surgery
- What is being tested?
- Prilocaine and Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2024to 15 Jan 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II.
- BMI < 35 kg/m2.
- Absence of micturition disorder.
- Patients scheduled for elective unilateral inguinal hernia with standard surgical technique (open anterior prosthetic inguinal hernioplasty) with previous ultrasonography confirmation of the diagnosis.
Who cannot join
- Allergic to any drug being used in the study.
- ASA III-IV.
- Suffering from bulky inguinal/inguino-scrotal hernias.
- Patients with infection at the injection site.
- Non-cooperative patients.
- Patients having sensory or motor deficit in lower extremities or history of micturition disorder, abnormal coagulation profile, history of alcohol or substance abuse.
- contraindications or failure of spinal anesthesia and surgery lasting more than 90 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Unilateral Intra-thecal Prilocaine-Fentanyl Versus Bupivacaine-Fentanyl On Post-Operative Spontaneous Voiding Within The Context Of Ambulatory Anesthesia. A Prospective Randomized Double-Blind Controlled Study
Background: In the context of day-case surgery, the optimal spinal anesthetic should give immediate and effective anesthesia for an appropriate period, followed by rapid regression of sensory and motor blocking, rapid bladder voiding, and little residual effects to allow for early ambulation and discharge. Although bupivacaine is safe and has a low rate of transient neurological symptoms (TNS), the prolonged sensory and motor block is a drawback for use in day-case spinal anesthesia. Similar to lidocaine, prilocaine is a local anesthetic with similar potency and duration of action and has been reported to have a lower incidence of TNS.
Objective: To determine which local anesthetic, Prilocaine with added fentanyl versus bupivacaine with added fentanyl, is better in the setting of fast-track anesthesia in patients undergoing unilateral inguinal hernia.
Material and methods: 70 Patients who were between 18-60 years old male patients, ASA grade I-II, BMI < 35, undergoing elective unilateral inguinal hernia, standard surgical technique (open anterior prosthetic inguinal hernioplasty) inguinal hernia diagnosis is confirmed by ultrasonography, free medical history of micturition disorder, procedure lasting less than 90 minutes, having provided written informed consent signed by the patient or guardian were included. Those patients were divided into two groups. Group Pr (Prilocaine 40mg + fentanyl 25μ) and group Bu (Bupivacaine 7.5mg + fentanyl 25mcg)
- Conditions
- Fast Track Surgery
- Being tested
- Prilocaine, Bupivacain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrilocaineDrug
Prilocaine 40mg (2ml) + fentanyl 25mcg in unilateral spinal anesthesia
BupivacainDrug
Bupivacaine 7.5mg (1.5ml) + fentanyl 25mcg in unilateral spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| prilocaine | Active comparator | Prilocaine 40mg (2ml) + fentanyl 25mcg in unilateral spinal anesthesia Receives: Drug: Prilocaine |
| Bupivacaine | Active comparator | Bupivacaine 7.5mg (1.5ml) + fentanyl 25mcg in unilateral spinal anesthesia Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative voiding
time for the first spontaneous micturition
Measured: first 2 hours postoperatively
Secondary outcomes (1)
peak level of spinal anesthesia
peak level of spinal anesthesia will be assessed by pinprick after 15 minutes from spinal anesthesia administration to determine the highest dermatome blocked.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start3 Aug 2024
- Primary completion30 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fast Track SurgeryStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- To compare unilateral intrathecal prilocaine versus bupivacaine with added fentanyl in both groups in inguinal hernia repair in the setting of fast-track anesthesia.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshira sayed mohamed, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262398
- Sponsor's protocol ID
- PT (862)
- Status last verified
- Aug 2024
- First submitted
- 14 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be provided upon request from the principal investigator
Publications
Manish B. Kotwani, Kanchan Rupwate, Prashanth Shivananda, et al. Comparison between high dose hyperbaric Bupivacaine (12.5 mg) alone versus low dose hyperbaric Bupivacaine (7.5mg) with Fentanyl (25 μg) in spinal Anaesthesia for inguinal hernia surgery. Int J Clin Trials. 2016 Aug; 3(3):140-146.
Rattenberry W, Hertling A, Erskine R. Spinal anaesthesia for ambulatory surgery. BJA Educ. 2019 Oct;19(10):321-328. doi: 10.1016/j.bjae.2019.06.001. Epub 2019 Aug 13. No abstract available.
PubMed 33456853Mohamed MAE, Helmy MA, Hashem OMEA, Shash AM, Osman ES, Mohamed AE, Taha MMR. Effect of unilateral intrathecal prilocaine-fentanyl versus bupivacaine-fentanyl on postoperative spontaneous voiding in ambulatory male patients undergoing inguinal hernioplasty: a randomized double-blinded comparative study. Sci Rep. 2026 Jul 5;16(1):20569. doi: 10.1038/s41598-026-59157-8.
PubMed 42402656
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Unilateral Intra-thecal Prilocaine-Fentanyl Versus Bupivacaine-Fentanyl On Post-Operative Spontaneous Voiding Within The Context Of Ambulatory Anesthesia. A Prospective Randomized Double-Blind Controlled Study
- ClinicalTrials.gov ID
- NCT07262398
- Acronym / sponsor ID
- PT (862)
- Conditions
- Fast Track Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 3 Dec 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.
Background: In the context of day-case surgery, the optimal spinal anesthetic should give immediate and effective anesthesia for an appropriate period, followed by rapid regression of sensory and motor blocking, rapid bladder voiding, and little residual effects to allow for early ambulation and discharge. Although bupivacaine is safe and has a low rate of transient neurological symptoms (TNS), the prolonged sensory and motor block is a drawback for use in day-case spinal anesthesia. Similar to lidocaine, prilocaine is a local anesthetic with similar potency and duration of action and has been reported to have a lower incidence of TNS.
Objective: To determine which local anesthetic, Prilocaine with added fentanyl versus bupivacaine with added fentanyl, is better in the setting of fast-track anesthesia in patients undergoing unilateral inguinal hernia.
Material and methods: 70 Patients who were between 18-60 years old male patients, ASA grade I-II, BMI < 35, undergoing elective unilateral inguinal hernia, standard surgical technique (open anterior prosthetic inguinal hernioplasty) inguinal hernia diagnosis is confirmed by ultrasonography, free medical history of micturition disorder, procedure lasting less than 90 minutes, having provided written informed consent signed by the patient or guardian were included. Those patients were divided into two groups. Group Pr (Prilocaine 40mg + fentanyl 25μ) and group Bu (Bupivacaine 7.5mg + fentanyl 25mcg)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To compare unilateral intrathecal prilocaine versus bupivacaine with added fentanyl in both groups in inguinal hernia repair in the setting of fast-track anesthesia.
| Arm | Type | Receives |
|---|---|---|
| prilocaine | Active comparator | Drug: PrilocainePrilocaine 40mg (2ml) + fentanyl 25mcg in unilateral spinal anesthesia |
| Bupivacaine | Active comparator | Drug: BupivacainBupivacaine 7.5mg (1.5ml) + fentanyl 25mcg in unilateral spinal anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I-II.
- BMI < 35 kg/m2.
- Absence of micturition disorder.
- Patients scheduled for elective unilateral inguinal hernia with standard surgical technique (open anterior prosthetic inguinal hernioplasty) with previous ultrasonography confirmation of the diagnosis.
Key exclusion criteria (7 listed)
- Allergic to any drug being used in the study.
- ASA III-IV.
- Suffering from bulky inguinal/inguino-scrotal hernias.
- Patients with infection at the injection site.
- Non-cooperative patients.
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 |
|---|---|---|
| PrilocainePrilocaine 40mg (2ml) + fentanyl 25mcg in unilateral spinal anesthesia | Drug | prilocaine |
| BupivacainBupivacaine 7.5mg (1.5ml) + fentanyl 25mcg in unilateral spinal anesthesia | Drug | Bupivacaine |
Primary outcome
postoperative voiding
Time frame: first 2 hours postoperatively
time for the first spontaneous micturition
1 secondary outcome
peak level of spinal anesthesia
Time frame: 15 minutes
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 3 Dec 2025.
- BackgroundManish B. Kotwani, Kanchan Rupwate, Prashanth Shivananda, et al. Comparison between high dose hyperbaric Bupivacaine (12.5 mg) alone versus low dose hyperbaric Bupivacaine (7.5mg) with Fentanyl (25 μg) in spinal Anaesthesia for inguinal hernia surgery. Int J Clin Trials. 2016 Aug; 3(3):140-146.
- Background: PubMed 33456853Rattenberry W, Hertling A, Erskine R. Spinal anaesthesia for ambulatory surgery. BJA Educ. 2019 Oct;19(10):321-328. doi: 10.1016/j.bjae.2019.06.001. Epub 2019 Aug 13. No abstract available.
- Derived from this study: PubMed 42402656Mohamed MAE, Helmy MA, Hashem OMEA, Shash AM, Osman ES, Mohamed AE, Taha MMR. Effect of unilateral intrathecal prilocaine-fentanyl versus bupivacaine-fentanyl on postoperative spontaneous voiding in ambulatory male patients undergoing inguinal hernioplasty: a randomized double-blinded comparative study. Sci Rep. 2026 Jul 5;16(1):20569. doi: 10.1038/s41598-026-59157-8.
- Individual participant dataSharing planned: Yes. data will be provided upon request from the principal investigator
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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 Phase 4 study testing Prilocaine and Bupivacain in people with Fast Track Surgery, run by Theodor Bilharz Research Institute 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 4 inclusion and 7 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 3 Dec 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.
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?
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?
postoperative voiding (time frame: first 2 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07262398, which also lists 3 linked publications.
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 3 Dec 2025.