Efficacy of Ultrasound-guided Axillary Nerve Block Versus Ultrasound-guided Peripheral Forearm Block in Patients Undergoing Hand Surgery

NCT04678765 | Completed

• 1 other identifier: JessaH_Axillaryblock
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

By means of an observer-blinded, mono-center, prospective, randomized controlled superiority trial, the total anesthesia-related time (sum of performance and onset times) of an ultrasound-guided distal peripheral nerve block and an ultrasound-guided axillary nerve block will be investigated in patients undergoing hand surgery. The hypothesis is that the onset-time of the ultrasound-guided distal peripheral nerve block will be faster than ultrasound-guided axillary nerve blocks, which is more suitable for hand surgery.

Conditions

Surgery; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Total anaesthesia-related time

  The total anesthesia-related time is the sum of block performance time and onset time of the block. Block performance time is defined as the time interval between the start of the block procedure and the end of the block procedure, thus imaging + needling time. Block performance time will be recorded with a stopwatch by the attending block room nurse. Time for the sensory block to take effect is defined as the time required for the limb to achieve a level of anesthesia deemed adequate for surgery (i.e., not necessarily a complete block) after placement of the block.

  Preoperative

Secondary Outcomes (18)

• Surgical block success rate

  Intraoperative

• Patient satisfaction

  Day 0 and day 1 postoperatively

• Needling time

  Preoperative

• Surgical time

  Intraoperative

• Total OR stay time

  Intraoperative

Study Arms (2)

Ultrasound-guided distal peripheral nerve block

ACTIVE COMPARATOR

Patients will receive the ultrasound-guided distal peripheral nerve block (locoregional anesthesia)

Procedure: Ultrasound-guided distal peripheral nerve block

Ultrasound-guided quadruple-injection axillary nerve block

EXPERIMENTAL

Patients will receive the ultrasound-guided quadruple-injection axillary nerve block (locoregional anesthesia)

Procedure: Ultrasound-guided quadruple-injection axillary nerve block

Interventions

Ultrasound-guided distal peripheral nerve block PROCEDURE

To localize the median nerve, the ultrasound transducer will be placed in a transverse orientation proximally to the wrist cease at mid-forearm level, with a slight tilt distally towards the hand. An in-plane ultrasound-guided medial-to-lateral puncture will be made and 3ml of 2% lidocaine was injected within the fascia that envelopes the median nerve. To perform the ulnar block, an ultrasound transducer will be placed in a transverse orientation over the ulnar side of the distal forearm. An in-plane ultrasound-guided medial-to-lateral or proximal-to distal puncture will be made and 3 ml of 2% lidocaine will be infiltrated into the fascial plane to block the ulnar nerve. Finally, we will apply a circumferential subcutaneous infiltration of 4 ml 2% lidocaine at the radial side of the wrist, 2cm proximal to the styloid process of the radius to block the terminal sensory branches of the radial, musculocutaneous, and medial antebrachial cutaneous nerves that may reach the palmar crease.

Ultrasound-guided distal peripheral nerve block

Ultrasound-guided quadruple-injection axillary nerve block PROCEDURE

The US probe will be applied in the axilla to obtain a short-axis view of the axillary artery. The following 4 nerves will be identified as hyperechoic structures: the median, ulnar, and radial nerve surrounding the axillary artery and the musculocutaneous nerve in the fascial layers between the biceps and coracobrachialis muscles. A total volume of 20 mL lidocaine 2% will be administered divided over 4 locations. The needle is inserted in-plane from the anterior aspect of the axillary artery and directed toward the posterior aspect of the axillary artery to first anesthetize the radial nerve. The posteriorly located radial nerve is surrounded with 8 mL of local anesthetic. Afterward, the needle is withdrawn and redirected to the median and ulnar nerves, after which another 8 mL of local anesthetic is deposited. In the end, the needle is withdrawn and redirected toward the musculocutaneous nerve where another 4 mL of local anesthetic is deposited.

Ultrasound-guided quadruple-injection axillary nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• ASA (American Society of Anesthesiology) classification: 1 - 3
• Scheduled for surgery in the day surgery unit
• Patients planned for unilateral hand surgery: carpal tunnel release, finger amputation (except digit I and II), finger manipulation (except digit I and II), hand foreign body removal (except digit I and II), hand incision and drainage, metacarpal fracture repair (except digit I and II), trigger finger release (except digit I), tendon repair (except digit I), and Dupuytren's contracture (except digit I)

You may not qualify if:

• Refusal of the patient
• Bilateral surgery
• BMI ≥ 40 kg/m²
• Puncture site infections
• Preexisting peripheral neuropathy
• Chronic pain syndrome
• Diabetes mellitus
• Pregnancy
• Use of strong pain medication in the past 3 months
• Allergy for any of the medications used
• Coagulation disorders or the use of anticoagulant therapy (vitamin K antagonists, new oral anticoagulants) or antiplatelet drugs (thienopyridines)
• Contra-indication for the use of a tourniquet
• Previous surgery in the same upper extremity
• Impossibility to understand the study protocol
• Not understanding the Dutch language

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 22, 2020
• Study Start: January 13, 2021
• Primary Completion: October 8, 2021
• Study Completion: October 31, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)