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Clinical Trials/NCT01701115
NCT01701115
Completed
Not Applicable

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

Hospital for Special Surgery, New York1 site in 1 country154 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block
Conditions
Shoulder Arthroscopy
Sponsor
Hospital for Special Surgery, New York
Enrollment
154
Locations
1
Primary Endpoint
Handgrip Strength
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
August 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital for Special Surgery, New York
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Low Dose (20 mL) Local Anesthetic

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.

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

Control Dose (40 mL) Local Anesthetic

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

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

Outcomes

Primary Outcomes

Handgrip Strength

Time Frame: 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 Outcomes

  • 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)
  • Side Effects(Postoperative Day 2)

Study Sites (1)

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