Effect of Local Anesthetic Dose on Interscalene Block

Not Applicable

Completed

• Conditions: Shoulder Arthroscopy; Interscalene Block
• Interventions: Procedure: Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block; Procedure: Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block

• Registration Number: NCT01701115
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital.

Detailed Description

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-04
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2017-04-03
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-02
• Last Update Submitted: 2017-10-02
• Results First Posted: 2017-10-04
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Age: 18 - 80 years old
• Surgical time < 2.5 hours
• ASA I, II or III
• Shoulder arthroscopy

Exclusion Criteria

• Age < 18 or > 80 years old
• Chronic pain patients (on narcotics/opioids > 3 months)
• Open shoulder surgical procedure
• BMI > 40
• Pre-existing neurological condition
• Patient refusal of interscalene block
• Severe respiratory disease or hemidiaphragmatic dysfunction
• Allergy to any local anesthetics
• Planned general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose (20 mL) Local Anesthetic	Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block	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.
Control Dose (40 mL) Local Anesthetic	Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block	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

Primary Outcome Measures

Name	Time	Method
Handgrip Strength	Difference between between baseline and postoperative.	The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.

Secondary Outcome Measures

Name	Time	Method
Patient Readiness to Discharge	Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)
Duration of Analgesia	Postoperative Day 2	Time to pain
Side Effects	Postoperative Day 2	Incidence of nausea

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States