Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- 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
Intervention: 5-min sitting duration after SBA (Other)
8-min group
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
Ahmed Hasanin
Professor
Cairo University
