Spinal AnesthesiaNCT06600048
Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery
A study testing Hyperbaric prilocaine and Hyperbaric bupivacaine in people with Spinal Anesthesia and Hyperbaric, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Anesthesia, Hyperbaric, Prilocaine
- What is being tested?
- Hyperbaric prilocaine and Hyperbaric bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Sep 2024to 1 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for perianal surgery under spinal anesthesia.
Who cannot join
- Allergy to the studied drugs.
- Patients with contraindications to spinal anesthesia.
- Patients with advanced cardiac, renal, or hepatic diseases.
- Previous voiding difficulty.
- Patients taking anticholinergic medications.
- Time of surgery exceeds 75 min.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery: A Randomized Controlled Trial
The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery.
Read the detailed description
Day-case spinal anesthesia with short-acting local anesthetics such as lidocaine and chloroprocaine can provide short times to discharge. However, the association of lidocaine with transient neurologic symptoms (TNS) and chloroprocaine with neurologic injury has limited the use of these agents in spinal anesthesia.
Hyperbaric bupivacaine has been used for spinal anesthesia for decades owing to the low incidence of TNS.
Prilocaine is also an amide local anesthetic that has an intermediate duration of action. It is available in the hyperbaric form that can be used for spinal anesthesia in day-case surgeries.
Hyperbaric prilocaine provides faster spinal block onset and earlier patient recovery in ambulatory surgery compared to plain prilocaine.
- Conditions
- Spinal Anesthesia, Hyperbaric, Prilocaine, Day-Case, Perianal Surgery
- Being tested
- Hyperbaric prilocaine, Hyperbaric bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric prilocaineDrug
Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.
Hyperbaric bupivacaineDrug
Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric prilocaine group | Experimental | Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine. Receives: Drug: Hyperbaric prilocaine |
| Hyperbaric bupivacaine group | Active comparator | Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine. Receives: Drug: Hyperbaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time till home readiness
The time-to-home readiness will be assessed as the time from the end of surgery until the patients reached a post-anesthesia discharge score (PADS) ≥9 and were able to void spontaneously or receive a urinary catheter, and the sensory block resolved to the S3 dermatome.
Measured: 24 hours postoperatively
Secondary outcomes (8)
Time to block regression
The time to block regression will be from intrathecal injection until sensation is regained at the S1 dermatome.
Measured: 6 hours postoperatively
Time of onset of motor block
The time of onset of the motor block will be assessed from intrathecal injection of local anesthetic until a grade 3 Bromage score is achieved
Measured: Intraoperatively
Time to spontaneous voiding
Time to spontaneous voiding will be recorded.
Measured: 24 hours postoperatively
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of pethidine administrated
Measured: 24 hours postoperatively
Total ketorolac consumption
Total ketorolac consumption will be recorded. If the numerical rating scale (NRS) becomes ≥3, 30 mg ketorolac IM will be given when needed (maximum every six hours).
Measured: 24 hours postoperatively
Heart rate
Heart rate will be recorded throughout the operation: every 5 minutes for the first 15 minutes and every 10 minutes until the end of the surgery.
Measured: Every 10 min till the end of surgery (up to 1 hour)
Mean arterial pressure
Mean arterial pressure will be recorded throughout the operation: every 5 minutes for the first 15 minutes and every 10 minutes until the end of the surgery.
Measured: Every 10 min till the end of surgery (up to 1 hour)
Incidence of adverse events
Incidence of adverse events such as postoperative nausea and vomiting (PONV), voiding difficulty, or any other complication.
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 posted19 Sep 2024
- Study start17 Sep 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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
- NCT06600048
- Sponsor's protocol ID
- 36264PR839/9/24
- Status last verified
- Mar 2025
- First submitted
- 12 Sep 2024
- Last updated
- 27 Mar 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06600048
- Acronym / sponsor ID
- 36264PR839/9/24
- Conditions
- Spinal Anesthesia, Hyperbaric, Prilocaine, Day-Case, Perianal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 19 Sep 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.
The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery.
Detailed description
Day-case spinal anesthesia with short-acting local anesthetics such as lidocaine and chloroprocaine can provide short times to discharge. However, the association of lidocaine with transient neurologic symptoms (TNS) and chloroprocaine with neurologic injury has limited the use of these agents in spinal anesthesia.
Hyperbaric bupivacaine has been used for spinal anesthesia for decades owing to the low incidence of TNS.
Prilocaine is also an amide local anesthetic that has an intermediate duration of action. It is available in the hyperbaric form that can be used for spinal anesthesia in day-case surgeries.
Hyperbaric prilocaine provides faster spinal block onset and earlier patient recovery in ambulatory surgery compared to plain prilocaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric prilocaine group | Experimental | Drug: Hyperbaric prilocainePatients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine. |
| Hyperbaric bupivacaine group | Active comparator | Drug: Hyperbaric bupivacainePatients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for perianal surgery under spinal anesthesia.
Key exclusion criteria (6 listed)
- Allergy to the studied drugs.
- Patients with contraindications to spinal anesthesia.
- Patients with advanced cardiac, renal, or hepatic diseases.
- 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 |
|---|---|---|
| Hyperbaric prilocainePatients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine. | Drug | Hyperbaric prilocaine group |
| Hyperbaric bupivacainePatients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine. | Drug | Hyperbaric bupivacaine group |
Primary outcome
Time till home readiness
Time frame: 24 hours postoperatively
The time-to-home readiness will be assessed as the time from the end of surgery until the patients reached a post-anesthesia discharge score (PADS) ≥9 and were able to void spontaneously or receive a urinary catheter, and the sensory block resolved to the S3 dermatome.
8 secondary outcomes
Time to block regression
Time frame: 6 hours postoperatively
Time of onset of motor block
Time frame: Intraoperatively
Time to spontaneous voiding
Time frame: 24 hours postoperatively
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Total ketorolac consumption
Time frame: 24 hours postoperatively
Heart rate
Time frame: Every 10 min till the end of surgery (up to 1 hour)
Mean arterial pressure
Time frame: Every 10 min till the end of surgery (up to 1 hour)
Incidence of adverse events
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 27 Mar 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.
Related trials for Spinal Anesthesia
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
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 Hyperbaric prilocaine and Hyperbaric bupivacaine in people with Spinal Anesthesia and Hyperbaric, 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 4 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: finished, as of the sponsor's last update on 27 Mar 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 till home readiness (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 27 Mar 2025.