Intravenous regional anesthesia versus axillar block for hand surgery in day-care hospitall: A prospective, randomised, comparative trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002325-11-BE

Enrollment

100

Registered

2016-06-28

Start date

2016-07-27

Completion date

Unknown

Last updated

2017-12-11

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

Conditions

intra and post operative pain management

Interventions

Trade Name: scandicaine Pharmaceutical Form: Injection INN or Proposed INN: Mepivacaine Other descriptive name: MEPIVACAINE HYDROCHLORIDE Concentration unit: % percent Concentration type: equal Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA I, II and III age>= 18 year Scheduled for Dupuytren release, endoscopic capal tunnel release or cyst of the wrist wriiten 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: - patient refusal - known allergy or hypersensivity to any drugs administered during this clinical trial - bilateral hand surgery -peripheral neuropathy - use of anti-coagulant drugs - uncontrolled arterial hypertension (systolic blood pressure > 170 mmHg) - Epilepsy - Sicle cell anemia - Vascular diseases - cardial conduction defect - infection or open wound at the location of the punction

Design outcomes

Primary

Measure	Time frame
Main Objective: No difference in patient satisfaction scores for both groups;Secondary Objective: - duration of anesthesia - duration of surgery - duration of the garotte - rediness for discharge - conversion to general anesthesia - duration of hospitalization - quality of the motor block - administered analgesics - cost price medication - post operative pain - PONV - recovery of the motor block;Primary end point(s): A difference in the patient satisfaction score of no more than 5 points;Timepoint(s) of evaluation of this end point: patient satisfaction score: when patient is ready for discharge.	—

Measure

Time frame

Main Objective: No difference in patient satisfaction scores for both groups;Secondary Objective: - duration of anesthesia - duration of surgery - duration of the garotte - rediness for discharge - conversion to general anesthesia - duration of hospitalization - quality of the motor block - administered analgesics - cost price medication - post operative pain - PONV - recovery of the motor block;Primary end point(s): A difference in the patient satisfaction score of no more than 5 points;Timepoint(s) of evaluation of this end point: patient satisfaction score: when patient is ready for discharge.

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Secondary

Measure	Time frame
Secondary end point(s): not apllicable;Timepoint(s) of evaluation of this end point: Postoperative pain score, PONV-score, Post Anesthesia Discharge scoring System, Motor block score: every 15min until discharge 24h after surgery: Pain score, PONV_score, evaluation motor block	—

Countries

Belgium

Contacts

Public ContactAnesthesie Research

University Hospital Leuven

christel.huygens@uzleuven.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 18, 2026