This prospective randomized trial compares duration of pain relief for specific blocks of leg nerves administered with the combination of bupivacaine and liposomal bupivacaine (Exparel®) to that of blocks administered with bupivacaine 0.5% alone and a group with general anesthesia whose postoperative pain is managed with oral pain killers per standard clinical practice.

Quality of analgesia after ultrasound-guided specific blocks of the distal tibial and deep peroneal nerves with 15 mL of a 50:50 mixture bupivacaine 0.5% and liposome bupivacaine (Exparel®) )1.3% vs. 15mL of bupivacaine 0.5% and vs. general anesthesia after hallux valgus surgery.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000961-22-BE

Enrollment

Registered

2016-03-22

Start date

2016-11-14

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Hallux valgus

Interventions

Trade Name: Exparel Pharmaceutical Form: Injection Trade Name: Marcaine 0.5% Product Name: Marcaine 0.5% Pharmaceutical Form: Injection Trade Name: Diprivan 1% Product Name: Diprivan 1% Pharmaceutic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Dutch or English speaking adults (age >18 years) • ASA I-III physical class • Scheduled for elective hallux valgus 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 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • History of allergy to a local anesthetic • Preexisting neurological deficit • Inability to give informed consent • Any medical condition that prevents assessment of sensory distribution or to communicate with staff • Pregnancy • Recent history of drug or alcohol abuse(<3months) • Concomitant opioid therapy • Coagulation disorders • Infection at site to be blocked • History of allergy or contraindications for paracetamol, ketorolac, dexamethasone, propofol, ketamine, midazolam

Design outcomes

Primary

Measure	Time frame
Main Objective: This prospective randomized trial compares duration of analgesia for specific blocks of the distal tibial and deep peroneal nerves administered with the combination of bupivacaine and liposomal bupivacaine (Exparel®) to that of blocks administered with bupivacaine 0.5% alone and a group with general anesthesia whose postoperative pain is managed with oral analgesics per standard clinical practice. We hypothesize that the combination of bupivacaine and liposomal bupivacaine (Exparel®) provides longer postoperative analgesia for open hallux valgus surgery compared to bupivacaine alone and the general anesthesia group. Primary outcome variables are: • duration of postoperative analgesia as measured by patient-reported numerical rating scale (NRS) pain scores at 1h ,2h, 24h, 48h, 72h, 96h, 7days, 6weeks following the surgical procedure •duration of sensory blockade measured at fixed intervals following the block procedure ;Secondary Objective: Secondary outcome variables are: - Postoperative supplementary use of analgesics - Overall benefit of analgesia score (OBAS)(8) - Sleep duration and quality - Operating room turnover time ;Primary end point(s): Primary outcome variables are: • duration of postoperative analgesia as measured by patient-reported numerical rating scale (NRS) pain scores at 1h ,2h, 24h, 48h, 72h, 96h, 7days, 6weeks following the surgical procedure •duration of sensory blockade measured at fixed intervals following the block procedure ;Timepoint(s) of evaluation of this end point: 1h ,2h, 24h, 48h, 72h, 96h, 7days, 6weeks following the surgical procedure	—

Measure

Time frame

Main Objective: This prospective randomized trial compares duration of analgesia for specific blocks of the distal tibial and deep peroneal nerves administered with the combination of bupivacaine and liposomal bupivacaine (Exparel®) to that of blocks administered with bupivacaine 0.5% alone and a group with general anesthesia whose postoperative pain is managed with oral analgesics per standard clinical practice. We hypothesize that the combination of bupivacaine and liposomal bupivacaine (Exparel®) provides longer postoperative analgesia for open hallux valgus surgery compared to bupivacaine alone and the general anesthesia group. Primary outcome variables are: • duration of postoperative analgesia as measured by patient-reported numerical rating scale (NRS) pain scores at 1h ,2h, 24h, 48h, 72h, 96h, 7days, 6weeks following the surgical procedure •duration of sensory blockade measured at fixed intervals following the block procedure ;Secondary Objective: Secondary outcome variables are: - Postoperative supplementary use of analgesics - Overall benefit of analgesia score (OBAS)(8) - Sleep duration and quality - Operating room turnover time ;Primary end point(s): Primary outcome variables are: • duration of postoperative analgesia as measured by patient-reported numerical rating scale (NRS) pain scores at 1h ,2h, 24h, 48h, 72h, 96h, 7days, 6weeks following the surgical procedure •duration of sensory blockade measured at fixed intervals following the block procedure ;Timepoint(s) of evaluation of this end point: 1h ,2h, 24h, 48h, 72h, 96h, 7days, 6weeks following the surgical procedure

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome variables are: - Postoperative supplementary use of analgesics - Overall benefit of analgesia score (OBAS)(8) - Sleep duration and quality - Operating room turnover time ;Timepoint(s) of evaluation of this end point: 1h ,2h, 24h, 48h, 72h, 96h, 7days, 6weeks following the surgical procedure	—

Countries

Belgium

Contacts

Public ContactDepartment of anesthesiology

Ziekenhuis Oost-Limburg

3289325309

Outcome results

None listed

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