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Completed

NCT Number: NCT00803725

Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy

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.

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Key information

Conditions

Knee Arthroscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients having unilateral arthroscopic surgery of the knee;
  • ASA I-III status;
  • Age 18-80 years;
  • BMI< 35.

Exclusion criteria

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

Treatment and study plan

Mepivacaine without fentanyl

Drug

45 mg 1.5% mepivacaine injection for spinal anesthesia

Mepivacaine with Fentanyl

Drug

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

Primary outcomes

  1. Time to complete motor block regression (0) as measured by modified Bromage scale.

    Time frame: Every 2 minutes from administration of the spinal until complete onset.

Secondary outcomes

  1. Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events.

    Time frame: Up to 72 hours after surgery.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 5, 2008
Registry last updated
Jan 26, 2010

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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