Can Different Intrathecal Drugs Affect Day Case Anal Surgery Recovery Duration?

Not Applicable

Completed

• Conditions: Effect of Drug
• Interventions: Drug: Bupivacaine-fentanyl

• Registration Number: NCT07156968
• Lead Sponsor: Ain Shams University

Brief Summary

This study aims to compare effect of adding fentanyl or dexmetomidine on duration of motor and sensory block after spinal anesthesia with prilocaine during day case perianal surgery and whether it impact time to discharge home.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-05-01
• Study First Submitted: 2024-08-26
• Status Verified: 2025-08
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Ages 18-70
• ASA 1-3
• height <155cm or >175cm
• Day case perianal surgery

Exclusion Criteria

• Hypersensitivity to the study drugs
• Refusal of patients.
• Patients with contraindications for spinal anesthesia
• previous voiding difficulty
• patients taking anticholinergic medications.
• emergency cases
• Patients with contraindications for day case sitting.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The bupivacaine-fentanyl group	Bupivacaine-fentanyl	-
The prilocaine-fentanyl group	Bupivacaine-fentanyl	-
The prilocaine-dexametomidine group	Bupivacaine-fentanyl	-

Primary Outcome Measures

Name	Time	Method
Sensory block resolution to S3 block	at 1 min intervals until the maximum block will be achieved and at 15 min intervals thereafter until the block resolved to S3 dermatome.	The sensory block will be measured at the midclavicular line with a pinprick test (via a 22 gauge hypodermic needle)
Home discharge	Home discharge will be assessed as the time from the end of surgery until the patients reach a post-anesthesia discharge score	(modified Alderts score) ≥9, able to void spontaneously and the sensory block resolves to the S3 dermatome.
incidence of postoperative urinary retention (POUR)	within 6 hours after surgery	The postoperative urinary retention (POUR) will be evaluated at hourly intervals in the PACU and ward; ultrasonic bladder scanning will be used for this purpose. If the bladder volume exceeds 500 mL and the patient has not voided spontaneously, urinary catheterization will be introduced.

Trial Locations

Locations (1)

Faculty of Medicine Ain Shams University; 🇪🇬 Cairo, Egypt