Continuous vs Liposomal Bupivacaine Interscalene Block for Proximal Humeral Fracture (CLIP)

NCT04928664 | Unknown Phase 4

• 1 other identifier: UW 20-247
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

Restricted range of shoulder motion following ORIF is a potential complication that severely affects the patients' functional outcome and should be actively avoided by means of adequate pain control in addition to early mobilization and physiotherapy. Peripheral nerve blocks, which can be given as a single injection or continuous infusion via an indwelling catheter, are analgesic options to be considered. Interscalene Block (ISB) is the regional analgesia of choice for the shoulder and proximal humerus region. While continuous infusion (aka continuous nerve block) offers the advantage of a longer duration of analgesia compared to a single injection of standard local anaesthetic, it is associated with an inherent risk of catheter displacement, dislodgement, obstruction, and infection. Compared to Standard Bupivacaine (SB), Liposomal Bupivacaine (LB) is a formulation designed to prolong the duration of action to up to 72 hours by slow release of bupivacaine from the multi-vesicular liposomes. Several studies have demonstrated satisfactory analgesic effects of liposomal bupivacaine given as local surgical site infiltration over placebo. However, the effects of single injection of liposomal bupivacaine given via local surgical site infiltration compared to continuous nerve block have been inconsistent. Administrating liposomal bupivacaine directly to peripheral nerve blocks is a potentially effective approach that has not been extensively studied. ISB with single shot liposomal bupivacaine has been shown to provide superior postoperative analgesia compared to ISB with injection of standard bupivacaine or placebo. ISB with liposomal bupivacaine could perhaps prolong and improve postoperative analgesia without the potential problems with continuous nerve blocks. The analgesic effect of ISB with single shot liposomal bupivacaine versus continuous ISB with standard bupivacaine has not been previously investigated. The aim of this study is to compare the analgesic effect of these two analgesic modalities for plate fixation of proximal humerus fractures.

Conditions

Shoulder Fractures

Keywords

liposomal bupivacaine; interscalene block

Outcome Measures

Primary Outcomes (1)

• Changes in Numerical Rating Score (NRS)

  NRS (movement) = NRS during attempted passive forward flexion to 90 degrees NRS (rest) = NRS at rest Pain at rest will be evaluated every 5 mins using NRS during recovery in PACU. NRS ranges from 0 to 10, where 0= no pain and 10= the worst imageable pain

  Changes from baseline NRS at day 7

Study Arms (2)

Liposoaml Bupivacaine (LB) Group

ACTIVE COMPARATOR

Intervention group

Drug: Liposomal bupivacaine

Standard Bupivacaine (SB) Group

EXPERIMENTAL

Control group

Drug: Standard bupivacaine

Interventions

Liposomal bupivacaine DRUG

Single shot injection of 10ml 1.33% LB; Due to the milky colour of LB, syringe containing the LB will be covered; Followed by placement of indwelling catheter in ISB; Catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse; The pump will be filled with 300ml NS; The default fixed rate of infusion will be 5ml/hr; Both the pump and the clamp will be covered by an aluminium foil; Catheter and pump will be removed on post-operative day 2

Liposoaml Bupivacaine (LB) Group

Standard bupivacaine DRUG

Single shot injection of 10 ml 0.25% SB in ISB; In order to have blinding to the drug injected, syringe containing SB will be covered; followed by placement of indwelling catheter in ISB; Catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse; The pump will be filled with 300ml 0.2% SB; The default fixed-rate of infusion will be 5ml/hr; Both the pump and the clamp will be covered by an aluminium foil; Catheter and pump will be removed on post-operative day 2

Standard Bupivacaine (SB) Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III
• Age between 18 and 80
• Proximal humeral fracture

You may not qualify if:

• Revision surgery
• Pathological fracture
• part or shaft fracture
• Multiple fractures
• Unable to attend rehabilitation
• Preexisting shoulder problems
• Abbreviated Mental Test Score (AMT score) \< 8
• 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, diamorphine, oxycodone, or meperidine) before operation

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Central Study Contacts

Timmy CW Chan, MBBS

CONTACT

(852)90280302; timmychancw@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The subjects, the investigators, and all the parties involved in patient management or data collection will be blinded throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Associate Professor

Model Details: A separate anaesthetist will then prepare 10 ml of LB or SB, and a covered elastomeric pump that is either filled with 300ml NS or with 300ml 0.2% SB according to the group assigned for the attending anaesthetist.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 16, 2021
• Study Start: June 4, 2019
• Primary Completion: December 1, 2023
• Study Completion: August 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)