Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery

NCT06600048 | Completed

• 1 other identifier: 36264PR839/9/24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery.

Conditions

Spinal Anesthesia; Hyperbaric; Prilocaine; Day-Case; Perianal Surgery

Outcome Measures

Primary Outcomes (1)

• Time till home readiness

  The time-to-home readiness will be assessed as the time from the end of surgery until the patients reached a post-anesthesia discharge score (PADS) ≥9 and were able to void spontaneously or receive a urinary catheter, and the sensory block resolved to the S3 dermatome.

  24 hours postoperatively

Secondary Outcomes (8)

• Time to block regression

  6 hours postoperatively

• Time of onset of motor block

  Intraoperatively

• Time to spontaneous voiding

  24 hours postoperatively

• Time to the 1st rescue analgesia

  24 hours postoperatively

• Total ketorolac consumption

  24 hours postoperatively

Study Arms (2)

Hyperbaric prilocaine group

EXPERIMENTAL

Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.

Drug: Hyperbaric prilocaine

Hyperbaric bupivacaine group

ACTIVE COMPARATOR

Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.

Drug: Hyperbaric bupivacaine

Interventions

Hyperbaric prilocaine DRUG

Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.

Hyperbaric prilocaine group

Hyperbaric bupivacaine DRUG

Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.

Hyperbaric bupivacaine group

Eligibility Criteria

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

You may qualify if:

• Age from 18 to 65 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Scheduled for perianal surgery under spinal anesthesia.

You may not qualify if:

• Allergy to the studied drugs.
• Patients with contraindications to spinal anesthesia.
• Patients with advanced cardiac, renal, or hepatic diseases.
• Previous voiding difficulty.
• Patients taking anticholinergic medications.
• Time of surgery exceeds 75 min.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 17, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)