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Clinical Trials/NCT07466121
NCT07466121CompletedNot Applicable

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

Cairo University1 site in 1 country66 target enrollmentStarted: March 15, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
66
Locations
1
Primary Endpoint
Time to readiness for discharge

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

5-min group

Active Comparator

Intervention: 5-min sitting duration after SBA (Other)

8-min group

Active Comparator

Intervention: 8-min sitting duration after SBA (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • time to void(from SBA till 24 hour postoperatively)
  • time to ambulation(from SBA till 24 hour postoperatively)
  • quality of recovery(at the end of 24 hour after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Hasanin

Professor

Cairo University

Study Sites (1)

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