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NCT Number: NCT07661628

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

The aim of this project is to describe the local use of intrathecal prilocaine, including the clinical characteristics of sensory and motor block, the incidence of anesthesia-related complications, and potential readmissions following outpatient knee arthroscopy.

Hypothesis: The use of prilocaine in short-duration outpatient knee arthroscopy facilitates early discharge from the recovery unit, allows rapid postoperative ambulation following spinal anesthesia, and is associated with a low incidence of complications such as urinary retention, postoperative nausea and vomiting, and hypotension, as reported in studies from other countries.

Research Question: What is the clinical performance of prilocaine in short-duration outpatient knee arthroscopy and what are the associated patient outcomes?

Materials and Methods

Following approval by the Institutional Ethics Committee of the Faculty of Medicine, Pontificia Universidad Católica de Chile (Santiago, Chile), and after obtaining written informed consent, a prospective study will be conducted in 50 ASA physical status I-II patients scheduled for outpatient knee arthroscopy. This sample represents a convenience cohort selected for descriptive purposes.

In the operating room, a peripheral intravenous catheter (18-20 G) will be inserted for the administration of fluids and medications. Spinal anesthesia will be performed using 40 mg of 2% prilocaine under standard monitoring, including continuous electrocardiography, noninvasive blood pressure monitoring, and pulse oximetry. Supplemental oxygen will be administered via Campbell mask, and sedation will be provided with 1-2 mg of midazolam.

The type and duration of surgery will be recorded. Anesthetic outcomes will include the duration of sensory and motor block, time to ambulation, time to first voiding, and time to discharge. In addition, complications occurring during the recovery period, including urinary retention, postoperative nausea and vomiting, and hypotension, will be documented.

No formal sample size calculation was performed, as the study will include a convenience sample of 50 patients.

A descriptive analysis will be conducted, with continuous variables reported as means and standard deviations. No inferential statistical tests will be performed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • outpatient knee arthroscopic surgery

Exclusion criteria

  • pediatric patients
  • hospitalized patients

Treatment and study plan

Primary outcomes

  1. Sensory block

    Time frame: From spinal anesthesia to discharge (4 hours)

    Sensory block after spinal anesthesia

  2. motor block

    Time frame: From spinal to discharge (4 hours)

    motor block after spinal anesthesia

Secondary outcomes

  1. Time to walk

    Time frame: From spinal anesthesia to discharge (4 hours)

    Time to walk

  2. Time to discharge

    Time frame: From spinal anesthesia to discharge (4 hours)

    Time to discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Marcia A Corvetto, MD

CONTACT

[email protected]

+56997423370

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Acronym: Prilocaine

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

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.

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