Effect of Local Anesthetic Dose on Interscalene Block

Shoulder Arthroscopy Clinical Trial

— Low Dose ISB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701115
• Other study ID #: 2012-011
• Status: Completed
• Phase: N/A
• First received: September 24, 2012
• Last updated: October 2, 2017
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: October 2017
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Interscalene Block
• Shoulder Arthroscopy

Intervention

Procedure:
• Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block
Anesthetic volume: Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL
• Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block
Anesthetic volume: Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL

Drug:
• Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)

• Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handgrip Strength	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.	Difference between between baseline and postoperative.
Secondary	Patient Readiness to Discharge		Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)
Secondary	Duration of Analgesia	Time to pain	Postoperative Day 2
Secondary	Side Effects	Incidence of nausea	Postoperative Day 2