NCT07466121

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2026

Completed
Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

March 8, 2026

Last Update Submit

July 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to readiness for discharge

    Patients will be considered ready for discharge when the modified Post Anaesthetic Discharge Scoring System (PADSS) \>9

    During the first 24 hour postoperatively

Secondary Outcomes (3)

  • 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

Study Arms (2)

5-min group

ACTIVE COMPARATOR
Other: 5-min sitting duration after SBA

8-min group

ACTIVE COMPARATOR
Other: 8-min sitting duration after SBA

Interventions

Patients will remain seated for 5 min after local anesthetic injection

5-min group

Patients will remain seated for 8 min after local anesthetic injection

8-min group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 12, 2026

Study Start

March 15, 2026

Primary Completion

July 15, 2026

Study Completion

July 16, 2026

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

data associated with this research are available form the PI upon reasonable request

Locations