Skip to main content
OpenTrials
Completed

NCT Number: NCT02472314

Exparel for Postoperative Pain Management in Shoulder Surgery

The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fracture of Shoulder and Upper Arm Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wayne State University Physician Group

Dearborn, Michigan, 48124, United States

About this study

liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing shoulder arthroplasty under general anesthesia
  • Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia
  • Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3
  • Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines.
  • Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond.
  • Patients available for follow up routine post-operative clinic visits, per standard of care.

Exclusion criteria

  • Contraindications to regional anesthesia
  • Significant peripheral neuropathy or neurological disorder affecting the upper extremity
  • Contraindication to a component of multimodal analgesia
  • Pregnancy
  • Opioid tolerance
  • Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.

Treatment and study plan

1.3% Liposomal Bupivacaine

Drug

local tissue infiltration of Liposomal Bupivacaine during surgery

Other names: Exparel

0.125% Bupivacaine

Drug

Continues nerve block with Bupivacaine during surgery and postoperatively

Other names: Bupivacaine

Primary outcomes

  1. Quality of Analgesia

    Time frame: 30 days

    Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively

Secondary outcomes

  1. Post Operative American Shoulder and Elbow Surgeons (ASES)

    Time frame: Preoperative, 6 weeks and last follow up

    American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome.

  2. Subjective Shoulder Value (SSV)

    Time frame: Pre-operative, 6 weeks and last Follow up

    Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100%

  3. Incidence of Nerve Injury

    Time frame: During hospital stay and at 2 weeks and 6 weeks post-operatively

    Neuropraxia on the treatment side

  4. Post Operative Opioid Consumption

    Time frame: During hospital stay up to 48 hours after surgery

    Cumulative amount of opioids administered during the time frame

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

A Novel Application of Exparel for Postoperative Pain Management in Shoulder Arthroplasty and Humerus Fracture Fixation

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2015
Registry last updated
Dec 29, 2023

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.

Related clinical trials

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