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Completed

NCT Number: NCT07466121

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

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.

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-min sitting duration after SBA

Other

Patients will remain seated for 5 min after local anesthetic injection

8-min sitting duration after SBA

Other

Patients will remain seated for 8 min after local anesthetic injection

Primary outcomes

  1. 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

  1. time to void

    Time frame: from SBA till 24 hour postoperatively

    time in min until patient able to urinate

  2. time to ambulation

    Time frame: from SBA till 24 hour postoperatively

    time in min from SBA until patient able to move independently

  3. quality of recovery

    Time frame: at the end of 24 hour after surgery

    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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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