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Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery

Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07466121
Enrollment
66
Registered
2026-03-12
Start date
2026-03-15
Completion date
2026-07-16
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Recovery (QoR-15), Readiness of Discharge, Saddle Block Anesthesia

Brief 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. 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.

Interventions

OTHER5-min sitting duration after SBA

Patients will remain seated for 5 min after local anesthetic injection

OTHER8-min sitting duration after SBA

Patients will remain seated for 8 min after local anesthetic injection

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients (21-65 years), ASA I-III undergoing perianal surgery.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Time to readiness for dischargeDuring the first 24 hour postoperativelyPatients will be considered ready for discharge when the modified Post Anaesthetic Discharge Scoring System (PADSS) \>9

Secondary

MeasureTime frameDescription
time to voidfrom SBA till 24 hour postoperativelytime in min until patient able to urinate
time to ambulationfrom SBA till 24 hour postoperativelytime in min from SBA until patient able to move independently
quality of recoveryat the end of 24 hour after surgeryusing 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026