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Completed

NCT Number: NCT01701115

Effect of Local Anesthetic Dose on Interscalene Block

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.

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Key information

Conditions

Shoulder Arthroscopy Interscalene Block

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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

Procedure

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

Procedure

Anesthetic volume:

Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL

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

Drug

Other names: Mepivacaine, Bupivacaine

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

Drug

Other names: Mepivacaine, Bupivacaine

Primary outcomes

  1. 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

  1. Patient Readiness to Discharge

    Time frame: Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)

  2. Duration of Analgesia

    Time frame: Postoperative Day 2

    Time to pain

  3. Side Effects

    Time frame: Postoperative Day 2

    Incidence of nausea

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Acronym: Low Dose ISB

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 4, 2012
Registry last updated
Oct 4, 2017

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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