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

NCT07156968 | Completed DMC

• 1 other identifier: R 138 / 2021
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (3)

• Sensory block resolution to S3 block

  The sensory block will be measured at the midclavicular line with a pinprick test (via a 22 gauge hypodermic needle)

  at 1 min intervals until the maximum block will be achieved and at 15 min intervals thereafter until the block resolved to S3 dermatome.

• Home discharge

  (modified Alderts score) ≥9, able to void spontaneously and the sensory block resolves to the S3 dermatome.

  Home discharge will be assessed as the time from the end of surgery until the patients reach a post-anesthesia discharge score

• incidence of postoperative urinary retention (POUR)

  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.

  within 6 hours after surgery

Study Arms (3)

The bupivacaine-fentanyl group

EXPERIMENTAL

Drug: Bupivacaine-fentanyl

The prilocaine-fentanyl group

EXPERIMENTAL

Drug: Bupivacaine-fentanyl

The prilocaine-dexametomidine group

EXPERIMENTAL

Drug: Bupivacaine-fentanyl

Interventions

Bupivacaine-fentanyl DRUG

A peripheral intravenous (IV) catheter will be inserted, and a 7 mL kg-1 crystalloid infusion will be initiated. The patients will be premedicated with 0.03 mg kg-1 midazolam IV. Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 min intervals during the procedure and at 15 min intervals during the post anesthesia care unit (PACU) stay. The baseline values will be recorded. Nasal oxygen 2 L min-1 will be administered during the whole procedure

Also known as: prilocaine-fentanyl, prilocaine-dexametomidine

The bupivacaine-fentanyl group; The prilocaine-dexametomidine group; The prilocaine-fentanyl group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 5, 2025
• Study Start: January 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

EG (1)