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Continuous Interscalene Block vs Liposomal Bupivacaine After Proximal Humerus Fracture Surgery (CLIP-H)

Primary Purpose

Shoulder Fractures

Status
Unknown status
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Liposomal bupivacaine
Standard bupivacaine
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Fractures focused on measuring interscalene nerve block, shoulder surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Revision surgery
  • Impaired cognitive function (Abbreviated Mental Test Score (AMT score) < 8)
  • 4 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
  • Neurological: Any Seizure Disorder
  • Psychiatric illnesses affecting pain perception e.g. severe depression and anxiety disorder
  • Alcohol or substance abuse
  • Chronic Pain, other than chronic knee pain
  • Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
  • Impaired Renal Function (defined as preoperative eGFR < 30ml /min /1.73 m2)
  • Impaired Hepatic Function
  • Pregnancy
  • Inability to use PCA
  • Patient refusal to ISB
  • Patient refusal to study
  • Patients do not understand Cantonese

Sites / Locations

  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal bupivacaine

Standard bupivacaine CISB

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Intraoperative opioid consumption
Intraoperative IV remifentanil consumption (mcg/kg/min)
Incidence of ISB related complications
Complications related to interscalene block
PCA morphine consumption
Amount of patient-controlled analgesia (PCA) morphine consumed (mg)
Number of patients with side effects effects of PCA using morphine
Side effects related to opioid use (Nausea/Vomiting, Dizziness, Constipation)
Rescue morphine consumption
Additional opioid used in addition to PCA morphine
Total length of stay
Duration of hospital stay (days)
Analgesic consumption after discharge
Total analgesic consumption (dihydrocodeine) after hospital discharge (pill count)
Overall Benefit of Analgesia Score (OBAS)
Patient-reported measure of pain, side effects, and satisfaction of post-operative analgesia; 7 questions rated from 0 (worst outcome) to 4 (best outcome)
Presence of chronic pain at follow-up
Presence of chronic pain by self-report
Presence of neuropathic pain at follow-up
Presence of neuropathic pain by physical examination and neuropathic pain questionnaire, a 10-item mixed self-report/observer rated physical exam measure ranging from 0 (no pain) to 10, with a score of 4 or greater diagnostic of neuropathic pain
Region-specific physical functioning and symptoms
Physical function and symptoms measured by Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), an 11-item patient-reported measure with a total score ranging from 0 (no disability) to 100 (most severe disability).
Health-related quality of life (HRQOL)
12-item Short Form Health Survey (SF-12), a patient-reported outcome measure of HRQOL comprised of a mental component (MCS) and physical component (PCS), each with a final score ranging from 0 (worst outcome) to 100 (best outcome).
Patient satisfaction as measured by the Patient Satisfaction Questionnaire General Satisfaction Subscale
Patient satisfaction with healthcare provision as measured by the Patient Satisfaction Questionnaire General Satisfaction subscale (PSQ18-GS), a two-item subscale with a final score ranging from 0 (lowest satisfaction) to 10 (highest satisfaction)

Full Information

First Posted
January 21, 2021
Last Updated
October 19, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05084573
Brief Title
Continuous Interscalene Block vs Liposomal Bupivacaine After Proximal Humerus Fracture Surgery
Acronym
CLIP-H
Official Title
Continuous Standard Bupivacaine Interscalene Block Versus Single Injection Liposomal Bupivacaine Following Surgical Fixation of Proximal Humerus Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Restricted range of motion following open reduction and internal fixation (ORIF) of proximal humerus fractures is a potential complication that severely limits functional outcomes . It must therefore be avoided by adequate pain control in order to allow for early mobilisation in addition to physiotherapy. Interscalene block (ISB) is one of the most effective and widely used regional analgesic options shoulder surgeries. ISB can be delivered as a single injection or by continuous infusion via an indwelling catheter. While continuous interscalene block (CISB) offers a longer duration of analgesia as compared to a single injection of the same anaesthetic, it carries an inherent risk of catheter malposition, dislodgement, and infection. As compared to standard bupivacaine (SB), liposomal bupivacaine (LB) is a formulation designed to prolong the duration of analgesia up to 72 hours via a single injection. While this could avoid the need for an indwelling catheter, results of studies comparing LB to CISB have been inconsistent. The purpose of this is non-inferiority trial is to compare the effectiveness of a single injection of LB versus CISB with SB on pain control following ORIF of proximal humerus fractures. The study hypothesis is that LB is not unacceptably worse than CISB with regard to pain control in the first two postoperative days. Patients providing informed consent will be screened for eligibility. All eligible patients will be randomly assigned in a double-blind manner (participant and investigator) and a 1:1 ratio to receive either LB or CISB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Fractures
Keywords
interscalene nerve block, shoulder surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be allocated to receive either continuous interscalene nerve block (CISB) using standard bupivacaine OR a single interscalene injection of liposomal bupivacaine (LB).
Masking
ParticipantCare ProviderInvestigator
Masking Description
Subjects, investigators, and all parties involved in patient management or data collection will be blinded throughout the study period.
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liposomal bupivacaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard bupivacaine CISB
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Single bolus injection 10mL 1.33% LB
Intervention Type
Drug
Intervention Name(s)
Standard bupivacaine
Other Intervention Name(s)
Marcaine, Sensorcaine
Intervention Description
Single bolus 10mL 0.25% SB + continuous 300mL 0.2% SB @5mL/hr
Primary Outcome Measure Information:
Title
Pain on movement as measured by Numerical Rating Scale (NRS)
Description
Numerical rating scale (NRS) during attempted passive forward shoulder flexion to 90 degrees; 0 points (no pain) to 11 points (worst pain imaginable).
Time Frame
At each post-op day 1-7
Title
Pain at rest as measured by Numerical Rating Scale (NRS)
Description
Numerical rating scale (NRS) at rest; 0 points (no pain) to 11 points (worst pain imaginable).
Time Frame
At each post-op day 1-7
Secondary Outcome Measure Information:
Title
Intraoperative opioid consumption
Description
Intraoperative IV remifentanil consumption (mcg/kg/min)
Time Frame
Intraoperative
Title
Incidence of ISB related complications
Description
Complications related to interscalene block
Time Frame
Intraoperative to post-op day 3
Title
PCA morphine consumption
Description
Amount of patient-controlled analgesia (PCA) morphine consumed (mg)
Time Frame
From immediately post-operation to post-op day 2
Title
Number of patients with side effects effects of PCA using morphine
Description
Side effects related to opioid use (Nausea/Vomiting, Dizziness, Constipation)
Time Frame
From immediately post-operation to post-op day 2
Title
Rescue morphine consumption
Description
Additional opioid used in addition to PCA morphine
Time Frame
From immediately post-operation to post-op day 2
Title
Total length of stay
Description
Duration of hospital stay (days)
Time Frame
Through study completion, an average of 1 year
Title
Analgesic consumption after discharge
Description
Total analgesic consumption (dihydrocodeine) after hospital discharge (pill count)
Time Frame
From post-op day 3 to day 7
Title
Overall Benefit of Analgesia Score (OBAS)
Description
Patient-reported measure of pain, side effects, and satisfaction of post-operative analgesia; 7 questions rated from 0 (worst outcome) to 4 (best outcome)
Time Frame
Immediate post-operation to post-op day 3
Title
Presence of chronic pain at follow-up
Description
Presence of chronic pain by self-report
Time Frame
At 2 weeks, 6 weeks and 3 months post-op
Title
Presence of neuropathic pain at follow-up
Description
Presence of neuropathic pain by physical examination and neuropathic pain questionnaire, a 10-item mixed self-report/observer rated physical exam measure ranging from 0 (no pain) to 10, with a score of 4 or greater diagnostic of neuropathic pain
Time Frame
At post-op 2 weeks, 6 weeks and 3 months
Title
Region-specific physical functioning and symptoms
Description
Physical function and symptoms measured by Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), an 11-item patient-reported measure with a total score ranging from 0 (no disability) to 100 (most severe disability).
Time Frame
At post-op 2 weeks, 6 weeks and 3 months
Title
Health-related quality of life (HRQOL)
Description
12-item Short Form Health Survey (SF-12), a patient-reported outcome measure of HRQOL comprised of a mental component (MCS) and physical component (PCS), each with a final score ranging from 0 (worst outcome) to 100 (best outcome).
Time Frame
At post-op 2 weeks, 6 weeks and 3 months
Title
Patient satisfaction as measured by the Patient Satisfaction Questionnaire General Satisfaction Subscale
Description
Patient satisfaction with healthcare provision as measured by the Patient Satisfaction Questionnaire General Satisfaction subscale (PSQ18-GS), a two-item subscale with a final score ranging from 0 (lowest satisfaction) to 10 (highest satisfaction)
Time Frame
At post-op 2 weeks, 6 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Revision surgery Impaired cognitive function (Abbreviated Mental Test Score (AMT score) < 8) 4 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 Neurological: Any Seizure Disorder Psychiatric illnesses affecting pain perception e.g. severe depression and anxiety disorder Alcohol or substance abuse Chronic Pain, other than chronic knee pain Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine) Impaired Renal Function (defined as preoperative eGFR < 30ml /min /1.73 m2) Impaired Hepatic Function Pregnancy Inability to use PCA Patient refusal to ISB Patient refusal to study Patients do not understand Cantonese
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi Wing Chan
Phone
22551740
Email
timmychancw@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Xinshuo Fang
Phone
22554581
Email
fangcx@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Wing Chan
Organizational Affiliation
Queen Mary Hospital, Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Xinshuo Fang
Organizational Affiliation
Queen Mary Hospital, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Wing Chan
Phone
22551740
Email
timmychancw@gmail.com
First Name & Middle Initial & Last Name & Degree
Chi Wing Chan
First Name & Middle Initial & Last Name & Degree
Christian Fang

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified dataset underlying results to be published as an appendix in final publication.
IPD Sharing Time Frame
Aim to publish protocol and analysis plan in a peer-reviewed journal prior to recruitment completion
IPD Sharing Access Criteria
Additional information available upon reasonable request of the corresponding author.
Citations:
PubMed Identifier
12729121
Citation
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.
Results Reference
background
PubMed Identifier
29576109
Citation
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.
Results Reference
background
PubMed Identifier
28781438
Citation
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.
Results Reference
background
PubMed Identifier
28844420
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
30583813
Citation
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.
Results Reference
background
PubMed Identifier
28390888
Citation
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.
Results Reference
background

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Continuous Interscalene Block vs Liposomal Bupivacaine After Proximal Humerus Fracture Surgery

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