Amount of pain reduction after a nerve block with 5 mL of bupivacaine 0.25% and 10 mL of Exparel® (133 mg) versus 15 mL of 0.25% bupivacaine after arthroscopic shoulder surgery

Quality of analgesia after interscalene block with 5 mL of bupivacaine 0.25% and 10 mL of Exparel® (133 mg) vs. 15 mL of 0.25% bupivacaine after arthroscopic shoulder surgery - Exparel-interscalene block study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001559-55-BE

Enrollment

Registered

2015-04-30

Start date

2015-05-28

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

Postoperative pain after arthroscopic shoulder surgery

Interventions

Trade Name: Exparel (liposomal bupivacaine) Product Name: Exparel liposomal bupivacaine Pharmaceutical Form: Injection Trade Name: Marcaine 0.5% Product Name: Marcaine 0.5% (bupivacaine) Pharmaceutic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Dutch or English speaking adults ? 18 years or older ASA I-III physical class ? Scheduled for elective arthroscopic shoulder surgery 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: ? History of allergy to a local anesthetic ? Baseline neurological deficit ? Medical condition that would make it difficult to assess sensory distribution or communicate with our staff ? Recent history (< 3 months) of drug or alcohol abuse ? Concomitant opioid therapy ? Preexisting coagulation disorder ? Infection at the injection site ? Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: This study is designed to compare the level and duration of pain control of 10 mL of Exparel® (133 mg) injected after 5 mL 0.25% bupivacaine and 15 mL of 0.25% bupivacaine alone for interscalne brachial plexus block. We hypothesize that level and duration of pain control of 5 mL 0.25% bupivacaine and 10 mL of Exparel® (133 mg) will exceed that of 15 mL of bupivacaine 0.25% alone for ISBPB. Primary outcome measures are: Total opioid consumption up to 72 h post surgery Time to first pain medicine request made by the patient ;Secondary Objective: Secondary outcome measures are: Numeric rating scores for pain on 0-10 scale (NRS) Overall Benefit of Analgesia Score (OBAS) Modified Brief Pain Inventory Scale (MBPI) Onset and duration of sensory block Onset and duration of motor block Duration of postoperative care unit stay Time to discharge home Incidence of postoperative nausea or vomiting through the first postoperative week (Postoperative Nausea and Vomiting (PONV) Intensity scale) Sleep quality and duration through the first postoperative week Patient satisfaction with pain control Functionality of operated arm ;Primary end point(s): Total opioid consumption up to 72 h post surgery Time to first pain medicine request made by the patient;Timepoint(s) of evaluation of this end point: 1h, 2h, 24h, 48h, 72h and 1 week postoperatively	—

Measure

Time frame

Main Objective: This study is designed to compare the level and duration of pain control of 10 mL of Exparel® (133 mg) injected after 5 mL 0.25% bupivacaine and 15 mL of 0.25% bupivacaine alone for interscalne brachial plexus block. We hypothesize that level and duration of pain control of 5 mL 0.25% bupivacaine and 10 mL of Exparel® (133 mg) will exceed that of 15 mL of bupivacaine 0.25% alone for ISBPB. Primary outcome measures are: Total opioid consumption up to 72 h post surgery Time to first pain medicine request made by the patient ;Secondary Objective: Secondary outcome measures are: Numeric rating scores for pain on 0-10 scale (NRS) Overall Benefit of Analgesia Score (OBAS) Modified Brief Pain Inventory Scale (MBPI) Onset and duration of sensory block Onset and duration of motor block Duration of postoperative care unit stay Time to discharge home Incidence of postoperative nausea or vomiting through the first postoperative week (Postoperative Nausea and Vomiting (PONV) Intensity scale) Sleep quality and duration through the first postoperative week Patient satisfaction with pain control Functionality of operated arm ;Primary end point(s): Total opioid consumption up to 72 h post surgery Time to first pain medicine request made by the patient;Timepoint(s) of evaluation of this end point: 1h, 2h, 24h, 48h, 72h and 1 week postoperatively

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Secondary

Measure	Time frame
Secondary end point(s): Numeric rating scores for pain on 0-10 scale (NRS) Overall Benefit of Analgesia Score (OBAS) Modified Brief Pain Inventory Scale (MBPI) Onset and duration of sensory block Onset and duration of motor block Duration of postoperative care unit stay Time to discharge home Incidence of postoperative nausea or vomiting through the first postoperative week (Postoperative Nausea and Vomiting (PONV) Intensity scale) Sleep quality and duration through the first postoperative week Patient satisfaction with pain control Functionality of operated arm ;Timepoint(s) of evaluation of this end point: 1h, 2h, 24h, 48h, 72h and 1 week postoperatively	—

Measure

Time frame

Secondary end point(s): Numeric rating scores for pain on 0-10 scale (NRS) Overall Benefit of Analgesia Score (OBAS) Modified Brief Pain Inventory Scale (MBPI) Onset and duration of sensory block Onset and duration of motor block Duration of postoperative care unit stay Time to discharge home Incidence of postoperative nausea or vomiting through the first postoperative week (Postoperative Nausea and Vomiting (PONV) Intensity scale) Sleep quality and duration through the first postoperative week Patient satisfaction with pain control Functionality of operated arm ;Timepoint(s) of evaluation of this end point: 1h, 2h, 24h, 48h, 72h and 1 week postoperatively

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Countries

Belgium

Contacts

Public ContactDepartment of Anesthesia

Ziekenhuis Oost-Limburg

catherine@nysora.com3289325305

Outcome results

None listed

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