Comparison Between Two Different Volumes of Anesthesia Drug in Forearm Surgery (COMBAX)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Forearm and Arm Surgery

Treatments: Drug: Xylocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01216488

RB09-060

Details and patient eligibility

About

Hospitalized patients for superior member surgery have different types of anesthesia.Forearm and/or arm surgery could be done under general anesthesia, but in the most of the cases, this surgery was done under locoregional anesthesia.Several injections of local anesthesia at the nerves axilla are used with the used of ultrasonography.

The purpose of this study is to show that the anesthesia efficiency is the same with 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.

Full description

Inclusion criteria :

• age > 18 years old
• patient who must have a non emergency surgery of the forearm or the hand
• ASA I or ASA II
• informed consent
• Ensured patient

Exclusion criteria :

• pregnancy
• respiratory insufficiency
• cardiac insufficiency
• hepatic insufficiency
• renal insufficiency
• ASA III or IV
• contraindications to the locoregional anesthesia
• contraindications to the xylocaine used
• patient participate to an another clinical study
• guardianship patient

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18 years old
• patient who must have a non emergency surgery of the forearm or the hand
• ASA I or ASA II
• informed consent
• Ensured patient

Exclusion criteria

• pregnancy
• respiratory insufficiency
• cardiac insufficiency
• hepatic insufficiency
• renal insufficiency
• ASA III or IV
• contraindications to the locoregional anesthesia
• contraindications to the xylocaine used
• patient participate to an another clinical study
• guardianship patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

40 ml of Xylocaine

Active Comparator group

Treatment:

Drug: Xylocaine

25 ml of Xylocaine

Experimental group

Treatment:

Drug: Xylocaine