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HealthyPrilocaineNCT07661628

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

An observational study of Healthy, run by Pontificia Universidad Catolica de Chile.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 31 Mar 2027
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: We will prospectively study 50 patients, ASA I-II, scheduled for outpatient arthroscopic knee surgery

Who may be able to join

  • outpatient knee arthroscopic surgery

Who cannot join

  • pediatric patients
  • hospitalized patients

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Marcia A Corvetto, MD contact

+56997423370

marciacorvetto@gmail.com

About this study

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.

Read more

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.

Read the 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

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.

Conditions
Healthy
Keywords
prilocaine, spinal anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07661628
Study groupRoleWhat they receive
single-group studySpinal anesthesia with prilocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensory block

    Sensory block after spinal anesthesia

    Measured: From spinal anesthesia to discharge (4 hours)

  2. motor block

    motor block after spinal anesthesia

    Measured: From spinal to discharge (4 hours)

Secondary outcomes (2)
  1. Time to walk

    Time to walk

    Measured: From spinal anesthesia to discharge (4 hours)

  2. Time to discharge

    Time to discharge

    Measured: From spinal anesthesia to discharge (4 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07661628
Sponsor's protocol ID
250926001
Acronym
Prilocaine
Status last verified
Jun 2026
First submitted
16 Jun 2026
Last updated
22 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ambrosoli AL, Di Carlo S, Crespi A, Severgnini P, Fedele LL, Cofini V, Necozione S, Musella G. Safety and effectiveness of prilocaine for spinal anesthesia in day surgery setting: a retrospective study on a sample of 3291 patients. J Anesth Analg Crit Care. 2023 Oct 20;3(1):40. doi: 10.1186/s44158-023-00122-6.

    PubMed 37864260

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Pontificia Universidad Catolica de Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marcia A Corvetto, MD (+56997423370, marciacorvetto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensory block (time frame: From spinal anesthesia to discharge (4 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07661628, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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