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Completed

NCT Number: NCT01977352

Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery

The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rotator Cuff Tear Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Luke's Roosevelt Hospital Center

New York, 10025, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • English speaking adults (age >17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity.

Exclusion criteria

  • Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.

Treatment and study plan

Liposomal bupivacaine

Drug

liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)

Other names: Exparel

Bupivacaine 0.25%

Drug

20 cc of bupivacaine 0.25%

Other names: Bupivacaine

Primary outcomes

  1. Total Opioid Consumption

    Time frame: Post op Day 1, post op Day 2, post op day 3, post op 1 week

    Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block.

Secondary outcomes

  1. Quality of Analgesia

    Time frame: Post op Day 1, post op Day 2, post op day 3, post op 1 week

    The Numeric Rating Scale (NRS-11) is an 11-point scale, from 0 = no pain to 10 = Severe Pain, for patient self-reporting of pain.

  2. Sensory and Motor Block

    Time frame: at 20 min and at 1 hour

    Measurement of brachial plexus blockade upon completion of the peripheral nerve block and prior to surgery. Sensory block will be assessed by pinprick with a paper clip using a 1-3 scale: 1, no block (complete sensation); 2, parasthesia (light touch); 3, anesthesia (no sensation). Motor block uses the same 1-3 scale: 1 = no block, 2= parasthesia and 3=anesthesia. Evaluation of sensory block will also be undertaken at one after arrival to the Post Anesthesia Care Unit (PACU). The first occurrence of pain perceived by the patient will be used as a surrogate for return of the sensory function.

  3. Time to First Pain Medicine

    Time frame: 72 hours

  4. Time to Discharge Home

    Time frame: 72 hours

    data not collected

  5. Incidence of Postoperative Nausea and Vomiting

    Time frame: 72 hours

  6. Sleep Quality

    Time frame: Post op Day 1, post op Day 2, post op day 3, post op 1 week

    scale of 0-10, 0=horrible, up all night; 10=perfect sleep

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Registry information

Official study title

Comparison of Cumulative Opioid Consumption After Interscalene Brachial Plexus Block With Liposomal Bupivacaine (Exparel; 88 mg in 20 cc) Versus Bupivacaine 0.25% for Arthroscopic Shoulder Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 6, 2013
Registry last updated
Apr 2, 2018

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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