NCT05084573

Brief Summary

The purpose of this study is to compare the efficacy of continuous interscalene block (CISB) using standard bupivacaine versus a single interscalene injection of liposomal bupivacaine (LB) on pain control following surgical fixation of proximal humerus fractures.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2020

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

January 21, 2021

Last Update Submit

October 19, 2021

Conditions

Shoulder Fractures

Keywords

interscalene nerve blockshoulder surgery

Outcome Measures

Primary Outcomes (2)

  • Pain on movement as measured by Numerical Rating Scale (NRS)

    Numerical rating scale (NRS) during attempted passive forward shoulder flexion to 90 degrees; 0 points (no pain) to 11 points (worst pain imaginable).

    At each post-op day 1-7

  • Pain at rest as measured by Numerical Rating Scale (NRS)

    Numerical rating scale (NRS) at rest; 0 points (no pain) to 11 points (worst pain imaginable).

    At each post-op day 1-7

Secondary Outcomes (13)

  • Intraoperative opioid consumption

    Intraoperative

  • Incidence of ISB related complications

    Intraoperative to post-op day 3

  • PCA morphine consumption

    From immediately post-operation to post-op day 2

  • Number of patients with side effects effects of PCA using morphine

    From immediately post-operation to post-op day 2

  • Rescue morphine consumption

    From immediately post-operation to post-op day 2

  • +8 more secondary outcomes

Study Arms (2)

Liposomal bupivacaine

EXPERIMENTAL

Patients will receive a single bolus interscalene injection of 10mL 1.33% LB followed by placement of indwelling (sham) catheter in the interscalene region. Upon arrival in the recovery room, a nurse will connect the catheter to a fixed-rate portable elastometric pump (Easypump®, B Braun, Germany) filled with 300mL normal saline (NS) at a default fixed rate of infusion of 5mL/hr. The syringe, catheter, pump and clamp will be covered by opaque black bags to conceal the milky appearance of LB. The catheter will be removed on postoperative day 2.

Drug: Liposomal bupivacaine

Standard bupivacaine CISB

ACTIVE COMPARATOR

Patients will receive a single bolus interscalene injection of 10mL 0.25% SB followed by placement of indwelling (sham) catheter in the interscalene region. Upon arrival in the recovery room, a nurse will connect the catheter to a fixed-rate portable elastometric pump (Easypump®, B Braun, Germany) filled with 300mL 0.2% SB at a default fixed rate of infusion of 5mL/hr. The syringe, catheter, pump and clamp will be covered by opaque black bags to conceal the drug appearance. The catheter will be removed on postoperative day 2.

Drug: Standard bupivacaine

Interventions

Liposomal bupivacaineDRUG

Single bolus injection 10mL 1.33% LB

Also known as: Exparel
Liposomal bupivacaine
Standard bupivacaineDRUG

Single bolus 10mL 0.25% SB + continuous 300mL 0.2% SB @5mL/hr

Also known as: Marcaine, Sensorcaine
Standard bupivacaine CISB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • Age between 18 and 80
  • Isolated Proximal humeral fracture (AO Types 31.A1-3 and B1-3 or Neer 2/3 part or greater tuberosity fracture equivalent)
  • Locking Plate fixation
  • Split deltoid minimal invasive approach

You may not qualify if:

  • Revision surgery
  • Impaired cognitive function (Abbreviated Mental Test Score (AMT score) \< 8)
  • part fractures
  • Poor surgical reduction quality
  • Unable to attend rehabilitation
  • Preexisting shoulder problems
  • Fracture fixation stability unable to tolerate early passive motion exercise
  • Use of implants other than a locking plate for fracture fixation
  • Activity of daily living is dependent on others
  • Polytrauma
  • Use of deltopectoral approach
  • Patient unable to follow post-operative rehabilitation protocol with early mobilization
  • Allergy to amide local anaesthetics, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS), opioids
  • Respiratory Disease with limited respiratory reserve
  • Cardiac Disease: Any degree of Heart Block, Heart Failure
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (7)

  • Hodgson SA, Mawson SJ, Stanley D. Rehabilitation after two-part fractures of the neck of the humerus. J Bone Joint Surg Br. 2003 Apr;85(3):419-22. doi: 10.1302/0301-620x.85b3.13458.

    PMID: 12729121BACKGROUND

  • Vorobeichik L, Brull R, Bowry R, Laffey JG, Abdallah FW. Should continuous rather than single-injection interscalene block be routinely offered for major shoulder surgery? A meta-analysis of the analgesic and side-effects profiles. Br J Anaesth. 2018 Apr;120(4):679-692. doi: 10.1016/j.bja.2017.11.104. Epub 2018 Feb 13.

    PMID: 29576109BACKGROUND

  • Malik O, Kaye AD, Kaye A, Belani K, Urman RD. Emerging roles of liposomal bupivacaine in anesthesia practice. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):151-156. doi: 10.4103/joacp.JOACP_375_15.

    PMID: 28781438BACKGROUND

  • Sabesan VJ, Shahriar R, Petersen-Fitts GR, Whaley JD, Bou-Akl T, Sweet M, Milia M. A prospective randomized controlled trial to identify the optimal postoperative pain management in shoulder arthroplasty: liposomal bupivacaine versus continuous interscalene catheter. J Shoulder Elbow Surg. 2017 Oct;26(10):1810-1817. doi: 10.1016/j.jse.2017.06.044. Epub 2017 Aug 24.

    PMID: 28844420BACKGROUND

  • Budge M, Orvets N, Shields E. Single-shot liposomal bupivacaine interscalene nerve block provides equivalent pain relief compared to continuous catheter interscalene nerve block in total shoulder arthroplasty. Seminars in Arthroplasty: JSES. 2020;30(4):285-90.

    BACKGROUND

  • Marino J, Scuderi G, Dowling O, Farquhar R, Freycinet B, Overdyk F. Periarticular Knee Injection With Liposomal Bupivacaine and Continuous Femoral Nerve Block for Postoperative Pain Management After Total Knee Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2019 Mar;34(3):495-500. doi: 10.1016/j.arth.2018.11.025. Epub 2018 Nov 23.

    PMID: 30583813BACKGROUND

  • Weller WJ, Azzam MG, Smith RA, Azar FM, Throckmorton TW. Liposomal Bupivacaine Mixture Has Similar Pain Relief and Significantly Fewer Complications at Less Cost Compared to Indwelling Interscalene Catheter in Total Shoulder Arthroplasty. J Arthroplasty. 2017 Nov;32(11):3557-3562. doi: 10.1016/j.arth.2017.03.017. Epub 2017 Mar 16.

    PMID: 28390888BACKGROUND

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Chi Wing Chan

    Queen Mary Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

  • Christian Xinshuo Fang

    Queen Mary Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Wing Chan

CONTACT

22551740timmychancw@gmail.com

Christian Xinshuo Fang

CONTACT

22554581fangcx@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Subjects, investigators, and all parties involved in patient management or data collection will be blinded throughout the study period.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be allocated to receive either continuous interscalene nerve block (CISB) using standard bupivacaine OR a single interscalene injection of liposomal bupivacaine (LB).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Clinical Associate Professor

Study Record Dates

First Submitted

January 21, 2021

First Posted

October 20, 2021

Study Start

August 1, 2020

Primary Completion

July 31, 2022

Study Completion

March 31, 2023

Last Updated

October 20, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

De-identified dataset underlying results to be published as an appendix in final publication.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Aim to publish protocol and analysis plan in a peer-reviewed journal prior to recruitment completion
Access Criteria
Additional information available upon reasonable request of the corresponding author.

Locations

HK(1)