The effect of the combination of midazolam with Ropivacaine in loco-regional anesthesia.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005457-31-BE

Enrollment

100

Registered

2012-03-20

Start date

2012-04-16

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

All patients scheduled for limb surgery

Interventions

Trade Name: Ropivacaïnehydrochloride Product Name: Ropivacaïnehydrochloride Pharmaceutical Form: Concentrate for solution for injection CAS Number: 98717-15-8 Other descriptive name: ROPIVACAINE HYDRO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients ASA class I and II scheduled for limb 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: All patients allergic to Midazolam and amide type local anesthetics and ASA class III and above.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the onset time of peripheral nerve block by adding Midazolam to Ropivacaïne;Secondary Objective: Evaluation of the quality, duration and the patient satisfaction after a peripheral nerve block.;Primary end point(s): Evaluation of the onset time of peripheral nerve block by adding Midazolam to Ropivacaïne;Timepoint(s) of evaluation of this end point: Immediately after the procedure, after 24 hrs and 6 weeks postoperatively	—

Measure

Time frame

Main Objective: Evaluation of the onset time of peripheral nerve block by adding Midazolam to Ropivacaïne;Secondary Objective: Evaluation of the quality, duration and the patient satisfaction after a peripheral nerve block.;Primary end point(s): Evaluation of the onset time of peripheral nerve block by adding Midazolam to Ropivacaïne;Timepoint(s) of evaluation of this end point: Immediately after the procedure, after 24 hrs and 6 weeks postoperatively

—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of the quality, duration and the patient satisfaction after a peripheral nerve block.;Timepoint(s) of evaluation of this end point: Immediately after the procedure, after 24 hrs and 6 weeks postoperatively	—

Countries

Belgium

Contacts

Public ContactVeerle Van Mossevelde

UZBrussel

veerle.vanmossevelde@uzbrussel.be003224763134

Outcome results

None listed

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