Saddle Block AnesthesiaNCT07466121
Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery
A study testing 5-min sitting duration after SBA and 8-min sitting duration after SBA in people with Saddle Block Anesthesia and Readiness of Discharge, run by Cairo University at 1 site in Egypt.
Trial summary
Most minor perianal surgeries are performed as day-case procedures requiring rapid recovery and effective symptom control. Saddle block anesthesia (SBA) provides reliable perineal anesthesia with minimal hemodynamic and motor effects, promoting faster recovery than general anesthesia. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Saddle Block Anesthesia, Readiness of Discharge, Quality of Recovery (QoR-15)
- What is being tested?
- 5-min sitting duration after SBA and 8-min sitting duration after SBA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2026to 16 Jul 2026
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (21-65 years), ASA I-III undergoing perianal surgery.
Who cannot join
- Severe cardiac morbidities (impaired contractility with ejection fraction < 40%, heart block, arrhythmias, tight valvular lesions)
- Contraindication to neuraxial anesthesia such as coagulopathy and local infection
- Pregnant or lactating women,
- Allergy of any of the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery: A Randomized Controlled Trial
Most minor perianal surgeries are performed as day-case procedures requiring rapid recovery and effective symptom control. Saddle block anesthesia (SBA) provides reliable perineal anesthesia with minimal hemodynamic and motor effects, promoting faster recovery than general anesthesia. However, the duration of sitting after intrathecal injection influences anesthetic spread, and the optimal sitting time to balance adequate anesthesia with early discharge remains unclear.
Read the detailed description
Spinal anesthesia will be administered in the sitting position at the L4-5 interspinous space using 7.5 mg of 0.5% hyperbaric bupivacaine.
Hemodynamic data (heart rate and blood pressure) will be recorded at baseline, then at 2 min interval after SBA until the end of surgery.
Postoperative pain will be assessed using the numeric rating scale at the post anesthesia care unit (PACU) and before discharge. If the numeric rating scale (NRS) > 3 or at any time if demanded by the patient, 15 mg of IV ketorolac will be given if persisted titrated doses of nalbuphine will be given In case of postoperative nausea and vomiting, 4 mg of IV ondansetron will be given.
- Being tested
- 5-min sitting duration after SBA, 8-min sitting duration after SBA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-min sitting duration after SBAOther
Patients will remain seated for 5 min after local anesthetic injection
8-min sitting duration after SBAOther
Patients will remain seated for 8 min after local anesthetic injection
| Study group | Role | What they receive |
|---|---|---|
| 5-min group | Active comparator | Not described Receives: Other: 5-min sitting duration after SBA |
| 8-min group | Active comparator | Not described Receives: Other: 8-min sitting duration after SBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to readiness for discharge
Patients will be considered ready for discharge when the modified Post Anaesthetic Discharge Scoring System (PADSS) >9
Measured: During the first 24 hour postoperatively
Secondary outcomes (3)
time to void
time in min until patient able to urinate
Measured: from SBA till 24 hour postoperatively
time to ambulation
time in min from SBA until patient able to move independently
Measured: from SBA till 24 hour postoperatively
quality of recovery
using QOR-15 score; 15-item questionnaire designed to assess a patient's quality of recovery following surgery and anesthesia It measures recovery across five key domains: physical comfort, pain, physical independence, psychological support, and emotional state.
Scoring Range: Each of the 15 questions is rated on an 11-point scale (0-10). The total score ranges from 0 (extremely poor recovery) to 150 (excellent recovery).
Measured: at the end of 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Mar 2026
- Primary completion15 Jul 2026
- Study completion16 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Saddle Block AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466121
- Sponsor's protocol ID
- MS-665-2025
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data associated with this research are available form the PI upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07466121
- Acronym / sponsor ID
- MS-665-2025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 12 Mar 2026 (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.
Most minor perianal surgeries are performed as day-case procedures requiring rapid recovery and effective symptom control. Saddle block anesthesia (SBA) provides reliable perineal anesthesia with minimal hemodynamic and motor effects, promoting faster recovery than general anesthesia. However, the duration of sitting after intrathecal injection influences anesthetic spread, and the optimal sitting time to balance adequate anesthesia with early discharge remains unclear.
Detailed description
Spinal anesthesia will be administered in the sitting position at the L4-5 interspinous space using 7.5 mg of 0.5% hyperbaric bupivacaine.
Hemodynamic data (heart rate and blood pressure) will be recorded at baseline, then at 2 min interval after SBA until the end of surgery.
Postoperative pain will be assessed using the numeric rating scale at the post anesthesia care unit (PACU) and before discharge. If the numeric rating scale (NRS) > 3 or at any time if demanded by the patient, 15 mg of IV ketorolac will be given if persisted titrated doses of nalbuphine will be given In case of postoperative nausea and vomiting, 4 mg of IV ondansetron will be given.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-min group | Active comparator | Other: 5-min sitting duration after SBA |
| 8-min group | Active comparator | Other: 8-min sitting duration after SBA |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (21-65 years), ASA I-III undergoing perianal surgery.
Key exclusion criteria (4 listed)
- Severe cardiac morbidities (impaired contractility with ejection fraction < 40%, heart block, arrhythmias, tight valvular lesions)
- Contraindication to neuraxial anesthesia such as coagulopathy and local infection
- Pregnant or lactating women,
- Allergy of any of the study drugs
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 |
|---|---|---|
| 5-min sitting duration after SBAPatients will remain seated for 5 min after local anesthetic injection | Other | 5-min group |
| 8-min sitting duration after SBAPatients will remain seated for 8 min after local anesthetic injection | Other | 8-min group |
Primary outcome
Time to readiness for discharge
Time frame: During the first 24 hour postoperatively
Patients will be considered ready for discharge when the modified Post Anaesthetic Discharge Scoring System (PADSS) >9
3 secondary outcomes
time to void
Time frame: from SBA till 24 hour postoperatively
time to ambulation
Time frame: from SBA till 24 hour postoperatively
quality of recovery
Time frame: at the end of 24 hour after surgery
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 20 Jul 2026.
- Individual participant dataSharing planned: No. data associated with this research are available form the PI upon reasonable request
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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 5-min sitting duration after SBA and 8-min sitting duration after SBA in people with Saddle Block Anesthesia and Readiness of Discharge, run by Cairo 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 1 inclusion and 4 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 20 Jul 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 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 readiness for discharge (time frame: During the first 24 hour 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 20 Jul 2026.