Comparison of continuous infusion versus automated bolus of local anesthetic for postoperative analgesia with popliteal sciatic nerve blockade (nerve catheters) in ambulatory foot surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002878-13-BE

Enrollment

Registered

2016-08-29

Start date

2016-10-03

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Elective foot surgery under sciatic nerve blockade. MedDRA version: 19.0 Level: PT Classification code 10036276 Term: Postoperative analgesia System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Chirocaine 1,25 mg/ml, oplossing voor infusie Pharmaceutical Form: Solution for infusion INN or Proposed INN: LEVOBUPIVACAINE HYDROCHLORIDE CAS Number: 27262-48-2 Other descriptive name: L

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Elective foot surgery under sciatic nerve blockade • 18–80 years old • ASA I-III • Able to comprehend, sign, and date the written informed consent document to participate in the clinical trial 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: • Patient refusal • Neurologic or neuromuscular disease, diabetic neuropathy • Anticoagulated patients • Skin infection at the site of needle insertion • Inability to understand numeric rating scale (NRS) scores • Patients with chronic pain disorders • Intra-articular injection by surgeon • Allergy to local anesthetics (amides specifically) • Contraindications for non-steroidal anti-inflammatory drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to compare postoperative analgesia with two different dosing regimens: a conventional continuous infusion and automated bolus of local anesthetic in continuous popliteal sciatic nerve blockade in outpatients undergoing elective foot surgery.;Secondary Objective: Not applicable;Primary end point(s): VAS score in two groups with different dosing regimens: continuous infusion versus automated bolus of local anesthetic during 48 hours postoperatively;Timepoint(s) of evaluation of this end point: during 48 hours postoperatively	—

Measure

Time frame

Main Objective: The objective of this study is to compare postoperative analgesia with two different dosing regimens: a conventional continuous infusion and automated bolus of local anesthetic in continuous popliteal sciatic nerve blockade in outpatients undergoing elective foot surgery.;Secondary Objective: Not applicable;Primary end point(s): VAS score in two groups with different dosing regimens: continuous infusion versus automated bolus of local anesthetic during 48 hours postoperatively;Timepoint(s) of evaluation of this end point: during 48 hours postoperatively

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Secondary

Measure	Time frame
Secondary end point(s): - incidence of breakthrough pain, consumption of rescue medication - technical problems related to the catheter - side effects (motor block en numbness) - complications (systemic or local toxicity) - feasibility of a remote control of NRS scores and pump’s settings by telemedicine transmission - patient satisfaction ;Timepoint(s) of evaluation of this end point: during 48 hours postoperatively	—

Measure

Time frame

Secondary end point(s): - incidence of breakthrough pain, consumption of rescue medication - technical problems related to the catheter - side effects (motor block en numbness) - complications (systemic or local toxicity) - feasibility of a remote control of NRS scores and pump’s settings by telemedicine transmission - patient satisfaction ;Timepoint(s) of evaluation of this end point: during 48 hours postoperatively

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Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

Bimetra.Clinics@uzgent.be+3293320500

Outcome results

None listed

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