Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy

NCT ID: NCT00803725

Last Updated: 2010-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if the addition of intrathecal fentanyl to low dose mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of motor blockade.

It is hypothesized that lower doses of spinal mepivacaine when combined with fentanyl will result in adequate surgical block for knee arthroscopy surgery with faster recovery and discharge compared to mepivacaine alone.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Arthroscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Mepivicaine for spinal anesthesia

Group Type ACTIVE_COMPARATOR

Mepivacaine without fentanyl

Intervention Type DRUG

45 mg 1.5% mepivacaine injection for spinal anesthesia

2

Mepivacaine with Fentanyl for spinal anesthesia

Group Type EXPERIMENTAL

Mepivacaine with Fentanyl

Intervention Type DRUG

10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mepivacaine without fentanyl

45 mg 1.5% mepivacaine injection for spinal anesthesia

Intervention Type DRUG

Mepivacaine with Fentanyl

10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients having unilateral arthroscopic surgery of the knee;
2. ASA I-III status;
3. Age 18-80 years;
4. BMI\< 35.

Exclusion Criteria

1. Patients who have previous history of hypersensitivity to local anesthetics or contraindications for spinal anesthesia (i.e. bleeding diathesis, coagulopathy);
2. Patients with radiating low back pain and neurological deficits in lower extremities;
3. Patients who are incapable of giving an informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Health Network

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

O'Donnell D, Manickam B, Perlas A, Karkhanis R, Chan VW, Syed K, Brull R. Spinal mepivacaine with fentanyl for outpatient knee arthroscopy surgery: a randomized controlled trial. Can J Anaesth. 2010 Jan;57(1):32-8. doi: 10.1007/s12630-009-9207-6. Epub 2009 Oct 24.

Reference Type DERIVED
PMID: 19856040 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07-0683-A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Knee Arthroscopy for Pain Control
NCT06701175 WITHDRAWN NA
Adductor Canal Block
NCT04513145 ACTIVE_NOT_RECRUITING PHASE2/PHASE3