Skip to main content
OpenTrials
Completed

NCT Number: NCT03728946

Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery

The purpose of this study is to examine the difference in perioperative pain after shoulder surgery with a standard bupivacaine nerve block compared to liposomal bupivacaine enhanced nerve block alone in TSA and ARCR. Data will be compared using VAS scores and opiate consumption between the two groups. The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greenwich Hospital, Greenwich, Connecticut, United States

Loading trial locations.

About this study

Arthroscopic rotator cuff repair (ARCR) and shoulder arthroplasty (TSA) provide excellent clinical outcomes but are often associated with significant postoperative pain, frequently managed with oral opioid medication. Orthopedic surgeons prescribe approximately 32 unused pills per shoulder surgery and are the third largest prescribers of opiates in the USA. It is incumbent upon the orthopedic community to identify postoperative pain management methods which reduce the need for narcotic medication following shoulder procedures as a means to mitigate the impact of orthopedic procedures on this epidemic.

The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is an accepted approach for managing surgical pain and reducing opiate use but requires peer reviewed protocols to gain wider acceptance.

Interscalene nerve block with bupivacaine remains a gold standard for peri-operative analgesia, but is associated with significant rebound pain due to the short duration of the local anesthetics. Recent studies have demonstrated that the addition of a liposomal bupivacaine field block may lower pain and enhance patient satisfaction throughout the first postoperative week. Liposomal bupivacaine has recently received FDA approval for ISB, but the data regarding its efficacy in nerve blocks is sparse.

The purpose of this pilot study is to determine if liposomal bupivacaine-enhanced interscalene nerve blocks can be used to improve peri-operative pain control methods, limit narcotic use, and provide appropriate postoperative analgesia compared to standard bupivacaine blocks. Primary and secondary outcome measures will be collected as number of opiates taken and self-reported VAS pain scores over a 14 day postoperative period, respectively.

The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 18 undergoing rotator cuff repair or total shoulder arthroplasty

Exclusion criteria

  • Pregnant
  • Documented drug of alcohol abuse
  • Active narcotic use prior to surgery
  • Neurological deficit
  • Allergy to amide anesthetics
  • Not cleared by primary care physician
  • Hydrocodone or oxycodone intolerance
  • Enrollment in another clinical trial or past cognitive or mental health status that interferes with study

Treatment and study plan

Liposomal bupivacaine

Drug

Addition of 15mL of liposomal bupivacaine to 15mL of standard nerve block anesthetic solution containing 0.5% bupivacaine and 4mg of decadron

Other names: EXPAREL

Primary outcomes

  1. Opiate Consumption

    Time frame: Post-operative days 1-14

    Total amount of narcotics consumed during the postoperative period, measured in morphine equivalents (OME)

Secondary outcomes

  1. VAS Pain Scores

    Time frame: Post operative days 1-14

    A standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively

  2. Likert Pain Satisfaction Rating

    Time frame: Post operative days 1-14

    A standardized measure of patient satisfaction with pain management from 1 (very unsatisfied) to 5 (very satisfied)

Sponsors and collaborators

Lead sponsor

Orthopaedic & Neurosurgery Specialists

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 2, 2018
Registry last updated
Mar 24, 2020

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.

Published trials that share one or more normalized conditions with this study.