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Clinical Trials/NCT07661628
NCT07661628Not yet recruitingNot Applicable

Clinical Characteristics of Prilocaine for Spinal Anesthesia in Ambulatory Surgery: Clinical Profile and Efficacy

Pontificia Universidad Catolica de Chile0 sites50 target enrollmentStarted: July 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50

Study Overview

Brief Summary

Introduction:

Hyperbaric prilocaine is widely used internationally for outpatient orthopedic and perineal surgery because of its favorable recovery profile compared with other intermediate-acting local anesthetics, such as bupivacaine, and its lower incidence of transient neurologic symptoms compared with lidocaine. Recently approved for intrathecal use in Chile, prilocaine offers advantages including shorter onset time, faster motor recovery, and earlier return of bladder function.

Objective:

To describe the clinical use of intrathecal prilocaine in outpatient knee arthroscopy, including the characteristics of sensory and motor block, incidence of anesthesia-related complications, and hospital readmissions. The study hypothesizes that prilocaine enables rapid postoperative recovery, early ambulation, and a low incidence of complications such as urinary retention, nausea and vomiting, and hypotension.

Methods:

Following institutional ethics committee approval and written informed consent, a prospective descriptive study will be conducted in 50 ASA physical status I-II patients undergoing ambulatory knee arthroscopy. Spinal anesthesia will be performed using 40 mg of 2% prilocaine under standard monitoring, with supplemental oxygen and midazolam sedation. Surgical type and duration will be recorded. Outcomes will include sensory and motor block duration, time to ambulation, time to first voiding, time to discharge, and the occurrence of complications such as urinary retention, nausea and vomiting, and hypotension during recovery. As this is a convenience sample, no formal sample size calculation has been performed. Data will be analyzed descriptively and reported as means and standard deviations, without inferential statistical testing.

Detailed Description

Introduction

The increasing number of surgical conditions managed in the outpatient setting has become a reality in contemporary clinical practice. Knee arthroscopy for meniscal pathology is a common orthopedic procedure of short duration that requires early postoperative discharge. In this ambulatory setting, spinal anesthesia plays an important role by providing adequate surgical anesthesia while maintaining a limited duration of action, thereby reducing recovery room stay and facilitating safe and efficient patient discharge.

Prilocaine is a local anesthetic widely used worldwide in ambulatory surgery, particularly for orthopedic and perineal procedures. It offers several advantages over other intermediate-acting local anesthetics, such as bupivacaine, and is associated with a lower incidence of transient neurologic symptoms compared with lidocaine.

Until recently, hyperbaric prilocaine had not been available in our country for intrathecal administration. Its use has now been approved by the Chilean Public Health Institute (ISP) (approval attached). Hyperbaric prilocaine has a favorable profile for ambulatory patients, including a shorter onset time, faster motor recovery, and a shorter time to first voiding.

Objective

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • outpatient knee arthroscopic surgery

Exclusion Criteria

  • pediatric patients
  • hospitalized patients

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marcia Antonia Corvetto Aqueveque

Professor

Pontificia Universidad Catolica de Chile

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