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.
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.
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 group | Role | What they receive |
|---|---|---|
| single-group study | Spinal anesthesia with prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory block
Sensory block after spinal anesthesia
Measured: From spinal anesthesia to discharge (4 hours)
motor block
motor block after spinal anesthesia
Measured: From spinal to discharge (4 hours)
Secondary outcomes (2)
Time to walk
Time to walk
Measured: From spinal anesthesia to discharge (4 hours)
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.
- First posted22 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Antonia Corvetto Aqueveque, Pontificia Universidad Catolica de Chile
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Prilocaine for Spinal Anesthesia in Ambulatory Surgery: Clinical Profile and Efficacy
- ClinicalTrials.gov ID
- NCT07661628
- Acronym / sponsor ID
- Prilocaine / 250926001
- Conditions
- Healthy
- Keywords
- prilocaine, spinal anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-group study | – | –Spinal anesthesia with prilocaine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will prospectively study 50 patients, ASA I-II, scheduled for outpatient arthroscopic knee surgery
Key inclusion criteria (1 listed)
- outpatient knee arthroscopic surgery
Key exclusion criteria (2 listed)
- pediatric patients
- hospitalized patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory block
Time frame: From spinal anesthesia to discharge (4 hours)
Sensory block after spinal anesthesia
motor block
Time frame: From spinal to discharge (4 hours)
motor block after spinal anesthesia
2 secondary outcomes
Time to walk
Time frame: From spinal anesthesia to discharge (4 hours)
Time to discharge
Time frame: From spinal anesthesia to discharge (4 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Results publication: PubMed 37864260Ambrosoli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.