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Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery

U

University of Parma

Status and phase

Completed
Phase 4

Conditions

Forearm Injuries
Orthopedic Surgery
Nerve Block
Trauma
Upper Extremity

Treatments

Drug: Midazolam
Procedure: Axillary brachial plexus nerve block
Drug: Fentanyl
Procedure: Infraclavicular brachial plexus block
Procedure: General anesthesia
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00724035
ANEST-ORT-02

Details and patient eligibility

About

This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques.

Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery.

The investigators will analyze how long it takes for anesthesia to be adequate for pain-free surgery, thus determine the optimal technique for this kind of surgery.

Full description

Real-time ultrasound guidance has substantially reduced the risk of pneumothorax and/or vascular puncture during infraclavicular brachial plexus blocks. The role of this technique has thus been expanded to overlap those procedures for which an axillary nerve block would be commonly considered as first choice.

A reference block for upper limb surgery thanks to its safety profile and clinical efficacy, the axillary approach may be more painful or unpleasant for some patients.

The investigators aim to determine possible differences in onset time and patient acceptance between the two techniques.

Enrollment

52 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA Physical Status Class <4
  • Scheduled upper extremity orthopedic surgery

Exclusion criteria

  • Psychiatric or cognitive disorder
  • Allergy to study drugs
  • Contraindication to nerve block at the assigned site

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

Infraclavicular
Experimental group
Description:
This group will receive an ultrasound-guided infraclavicular brachial plexus block.
Treatment:
Drug: Ropivacaine
Drug: Midazolam
Procedure: General anesthesia
Procedure: Infraclavicular brachial plexus block
Drug: Fentanyl
Axillary
Active Comparator group
Description:
This group will receive an ultrasound-guided axillary brachial plexus block.
Treatment:
Drug: Ropivacaine
Drug: Midazolam
Procedure: General anesthesia
Drug: Fentanyl
Procedure: Axillary brachial plexus nerve block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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