Completed

Low Dose ISBEffect of Local Anesthetic Dose on Interscalene Block for Shoulder Arthroscopy, Patient Satisfaction and Return of Handgrip Strength

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What is being tested

Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block

+ Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)

+ Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block

ProcedureDrug
Who is being recruted

From 18 to 80 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorHospital for Special Surgery, New York
Last updated: October 4, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

Traditionally, an interscalene block is done either with nerve stimulator or ultrasound guided using 40-60mL of local anesthetic. The study plans to investigate the difference in hand grip strength post-operatively in patients who will receive interscalene blocks with 40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve adequate surgical anesthesia while creating less motor block and thus, increase patient satisfaction, present fewer complications or adverse affects and decrease time in the recovery room.

NCT01701115
Principal SponsorHospital for Special Surgery, New York
Last updated: October 4, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

154 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
ASA I, II or III
Age: 18 - 80 years old
Shoulder arthroscopy
Surgical time < 2.5 hours
9 exclusion criteria prevent from participating
Age < 18 or > 80 years old
Allergy to any local anesthetics
BMI > 40
Chronic pain patients (on narcotics/opioids > 3 months)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.

Group II

Active Comparator
Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hospital for Special Surgery

New York, United StatesOpen Hospital for Special Surgery in Google Maps
CompletedOne Study Center