Effect of DrugNCT07156968
Can Different Intrathecal Drugs Affect Day Case Anal Surgery Recovery Duration?
A study testing Bupivacaine-fentanyl in people with Effect of Drug, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare effect of adding fentanyl or dexmetomidine on duration of motor and sensory block after spinal anesthesia with prilocaine during day case perianal surgery and whether it impact time to discharge home. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Bupivacaine-fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 May 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-70
- ASA 1-3
- height <155cm or >175cm
- Day case perianal surgery
Who cannot join
- Hypersensitivity to the study drugs
- Refusal of patients.
- Patients with contraindications for spinal anesthesia
- previous voiding difficulty
- patients taking anticholinergic medications.
- emergency cases
- Patients with contraindications for day case sitting.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare effect of adding fentanyl or dexmetomidine on duration of motor and sensory block after spinal anesthesia with prilocaine during day case perianal surgery and whether it impact time to discharge home.
- Conditions
- Effect of Drug
- Being tested
- Bupivacaine-fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-fentanylDrug
Also called prilocaine-fentanyl, prilocaine-dexametomidine
A peripheral intravenous (IV) catheter will be inserted, and a 7 mL kg-1 crystalloid infusion will be initiated. The patients will be premedicated with 0.03 mg kg-1 midazolam IV. Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 min intervals during the procedure and at 15 min intervals during the post anesthesia care unit (PACU) stay. The baseline values will be recorded. Nasal oxygen 2 L min-1 will be administered during the whole procedure
| Study group | Role | What they receive |
|---|---|---|
| The bupivacaine-fentanyl group | Experimental | Not described Receives: Drug: Bupivacaine-fentanyl |
| The prilocaine-fentanyl group | Experimental | Not described Receives: Drug: Bupivacaine-fentanyl |
| The prilocaine-dexametomidine group | Experimental | Not described Receives: Drug: Bupivacaine-fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory block resolution to S3 block
The sensory block will be measured at the midclavicular line with a pinprick test (via a 22 gauge hypodermic needle)
Measured: at 1 min intervals until the maximum block will be achieved and at 15 min intervals thereafter until the block resolved to S3 dermatome.
Home discharge
(modified Alderts score) ≥9, able to void spontaneously and the sensory block resolves to the S3 dermatome.
Measured: Home discharge will be assessed as the time from the end of surgery until the patients reach a post-anesthesia discharge score
incidence of postoperative urinary retention (POUR)
The postoperative urinary retention (POUR) will be evaluated at hourly intervals in the PACU and ward; ultrasonic bladder scanning will be used for this purpose. If the bladder volume exceeds 500 mL and the patient has not voided spontaneously, urinary catheterization will be introduced.
Measured: within 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Jan 2022
- Primary completion1 Feb 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Sayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156968
- Sponsor's protocol ID
- R 138 / 2021
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Different Intrathecal Drugs Affect Day Case Anal Surgery Recovery Duration?
- ClinicalTrials.gov ID
- NCT07156968
- Acronym / sponsor ID
- R 138 / 2021
- Conditions
- Effect of Drug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 5 Sep 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 compare effect of adding fentanyl or dexmetomidine on duration of motor and sensory block after spinal anesthesia with prilocaine during day case perianal surgery and whether it impact time to discharge home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The bupivacaine-fentanyl group | Experimental | Drug: Bupivacaine-fentanyl |
| The prilocaine-fentanyl group | Experimental | Drug: Bupivacaine-fentanyl |
| The prilocaine-dexametomidine group | Experimental | Drug: Bupivacaine-fentanyl |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18-70
- ASA 1-3
- height <155cm or >175cm
- Day case perianal surgery
Key exclusion criteria (7 listed)
- Hypersensitivity to the study drugs
- Refusal of patients.
- Patients with contraindications for spinal anesthesia
- previous voiding difficulty
- patients taking anticholinergic medications.
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 |
|---|---|---|
| Bupivacaine-fentanylAlso: prilocaine-fentanyl, prilocaine-dexametomidineA peripheral intravenous (IV) catheter will be inserted, and a 7 mL kg-1 crystalloid infusion will be initiated. The patients will be premedicated with 0.03 mg kg-1 midazolam IV. Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 min intervals during the procedure and at 15 min intervals during the post anesthesia care unit (PACU) stay. The baseline values will be recorded. Nasal oxygen 2 L min-1 will be administered during the whole procedure | Drug | The bupivacaine-fentanyl group, The prilocaine-dexametomidine group, The prilocaine-fentanyl group |
Primary outcome
Sensory block resolution to S3 block
Time frame: at 1 min intervals until the maximum block will be achieved and at 15 min intervals thereafter until the block resolved to S3 dermatome.
The sensory block will be measured at the midclavicular line with a pinprick test (via a 22 gauge hypodermic needle)
Home discharge
Time frame: Home discharge will be assessed as the time from the end of surgery until the patients reach a post-anesthesia discharge score
(modified Alderts score) ≥9, able to void spontaneously and the sensory block resolves to the S3 dermatome.
incidence of postoperative urinary retention (POUR)
Time frame: within 6 hours after surgery
The postoperative urinary retention (POUR) will be evaluated at hourly intervals in the PACU and ward; ultrasonic bladder scanning will be used for this purpose. If the bladder volume exceeds 500 mL and the patient has not voided spontaneously, urinary catheterization will be introduced.
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 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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 Bupivacaine-fentanyl in people with Effect of Drug, run by Ain Shams 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 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 5 Sep 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?
Sensory block resolution to S3 block (time frame: at 1 min intervals until the maximum block will be achieved and at 15 min intervals thereafter until the block resolved to S3 dermatome.). The study lists 3 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 5 Sep 2025.