Study to desribe the processing of bupivacaine in the body when Exparel is injected around the nerves in the neck for pain treatment in total shoulder replacement.

Pharmacokinetic Profile of Liposome Bupivacaine (Exparel®) after Perineural Admission in the Interscalene Groove for Primary Total Shoulder Arthroplasty. - KiNEX

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002402-36-NL

Enrollment

Registered

2015-07-29

Start date

2015-08-27

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients receiving a primary total shoulder arthroplasty

Interventions

Trade Name: Exparel Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age =18 years - ASA physical health classification I-II - Patient planned for a primary unilateral total shoulder arthroplasty or reversed shoulder arthroplasty under total anesthesia with a locoregional anesthetic block - Hb >7.5 mmol/L - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - BMI (body mass index) >35kg/m2 - Known hypersensitivity to amide-type local anesthetics - Chronic use of opiates - Contraindication for paracetamol, NSAID’s or opiates. - COPD gold 3-4 or any other pulmonary disease that significantly affects pulmonary function - Hepatic or renal insufficiency - Use of fluvoxamine, ciproflocaxine, ketoconazol, erytromycine, claritromycine, itraconazol or rifampicine because of their effect on bupivacaine clearance. - Inadequate proficiency in Dutch. - Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial is to describe a pharmacokinetic profile of total and unbound plasma concentrations of bupivacaine, when Exparel is used as interscalene nerve block as analgesia for primary total shoulder arthroplasty. ;Secondary Objective: The secondary objectives of this study are to describe the postoperative pain (in numeric rating scale), the post operative opiate use and the experienced side effects/(S)AEs.;Primary end point(s): - Mean total and unbound maximum serum concentration of bupivacaine (Cmax) - Mean time to total and unbound maximum serum concentration of bupivacaine (Tmax);Timepoint(s) of evaluation of this end point: Befor Surgery and at t 0.5, 1, 2, 4, 8, 12, 24, 26, 48, 72 hours after admission of Exparel	—

Measure

Time frame

Main Objective: The primary objective of this trial is to describe a pharmacokinetic profile of total and unbound plasma concentrations of bupivacaine, when Exparel is used as interscalene nerve block as analgesia for primary total shoulder arthroplasty. ;Secondary Objective: The secondary objectives of this study are to describe the postoperative pain (in numeric rating scale), the post operative opiate use and the experienced side effects/(S)AEs.;Primary end point(s): - Mean total and unbound maximum serum concentration of bupivacaine (Cmax) - Mean time to total and unbound maximum serum concentration of bupivacaine (Tmax);Timepoint(s) of evaluation of this end point: Befor Surgery and at t 0.5, 1, 2, 4, 8, 12, 24, 26, 48, 72 hours after admission of Exparel

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Secondary

Measure	Time frame
Secondary end point(s): Age, weight, height, gender, co-medication and systemic diseases will be reported as baseline variables. Secondary endpoints: Post-operative pain intensity (NRS), post-operative use of opiates (PCIA morphine) and: side effects, complications and signs of systemic toxicity will be recorded. ((S)AEs) ;Timepoint(s) of evaluation of this end point: Baseline variables: baseline Secondary endpoint: untill 72 hours postoperative. If hospital stay is extended due to complications, (S)AEs will be followed untill resolved or recovered with sequalae.	—

Measure

Time frame

Secondary end point(s): Age, weight, height, gender, co-medication and systemic diseases will be reported as baseline variables. Secondary endpoints: Post-operative pain intensity (NRS), post-operative use of opiates (PCIA morphine) and: side effects, complications and signs of systemic toxicity will be recorded. ((S)AEs) ;Timepoint(s) of evaluation of this end point: Baseline variables: baseline Secondary endpoint: untill 72 hours postoperative. If hospital stay is extended due to complications, (S)AEs will be followed untill resolved or recovered with sequalae.

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Countries

Netherlands

Contacts

Public Contactafdeling Research

Sint Maartenskliniek

secretariaat.research@maartenskliniek.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026