Skip to main content
OpenTrials
Completed

NCT Number: NCT07156968

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Effect of Drug

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Other names: prilocaine-fentanyl, prilocaine-dexametomidine

Primary outcomes

  1. Sensory block resolution to S3 block

    Time frame: 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)

  2. Home discharge

    Time frame: 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.

  3. incidence of postoperative urinary retention (POUR)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.