Ultrasound-guided Peripheral Nerve Block Versus Forearm Bier's Block in Patients Undergoing Carpal Tunnel Release

NCT03411551 | Completed

• 1 other identifier: 17.118/ANESTH17.03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

By means of an observer-blinded, randomized controlled trial, the analgesic efficacy of the forearm intravenous regional anesthesia and the ultrasound guided peripheral nerve block will be investigated in patients undergoing carpal tunnel release. The hypothesis is that the ultrasound-guided peripheral nerve block is superior compared to the forearm intravenous regional anesthesia with respect to the analgesic efficacy. Furthermore, pre-, intra-, and post-operative pain will be investigated at several time points as well as general patient satisfaction and satisfaction of the surgeon regarding the procedures.

Conditions

Carpal Tunnel Syndrome; Anesthesia, Local

Keywords

Intravenous anesthesia; Nerve Block; Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Analgesic effectivity

  This study wants to evaluate and compare the analgesic effectivity of the intravenous regional anesthesia (IVRA; mini-Bier's block) and the ultrasound-guided peripheral nerve block. The blinded surgeon will assess the analgesic effectivity and grade it as either complete (grade 1 and grade 2) or incomplete (grade 3 and grade 4). Grade 1 is defined as complete motor and sensory blockade; grade 2 is defined as partial motor blockade with no pain or deep pressure sensitivity. Grade 3 is defined as partial motor blockade with mild pain and the need for rescue local or opioid analgesia. Grade 4 is defined as incomplete motor and sensory blockade requiring sedation/conversion to general anesthesia.

  Intraoperative

Secondary Outcomes (9)

• Pre operative pain

  Start of anesthesia technique

• Pre operative pain

  Intraoperative

• Intra-operative: pain

  Intraoperative

• Time in operating room

  Intraoperative

• Time of surgical procedure

  Intraoperative

Study Arms (2)

Forearm Bier's block

ACTIVE COMPARATOR

Forearm intravenous regional anesthesia (Bier's block)

Procedure: regional anesthesia

Peripheral Nerve Block

EXPERIMENTAL

Ultrasound-guided peripheral nerve block (regional anesthesia)

Procedure: regional anesthesia

Interventions

regional anesthesia PROCEDURE

The analgesic effectivity of the forearm intravenous regional anesthesia and the ultrasound-guided peripheral nerve block will be investigated in patients undergoing carpal tunnel release

Forearm Bier's block; Peripheral Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 years of age
• American Society of Anesthesiology (ASA) physical status classification: 1-3
• Patients planned to undergo carpal tunnel release via regional anesthesia (intravenous regional anesthesia or ultra-sound guided peripheral nerve block)

You may not qualify if:

• Bilateral surgery
• BMI ≥ 40 kg/m2
• Infection in the area of the peripheral nerve block injection site
• History of neurological conditions
• Chronic pain symptoms
• Concomitant use of Opioids in the last 3 months
• Diabetes mellitus type-1 (insulin dependent diabetes mellitus)
• Diabetes mellitus with organ damage
• Oversensitivity to local anesthesia
• Blood clotting disorder
• History of any surgical procedure in the arm that needs to be operated
• Inability to understand and adhere to the study design

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (3)

• Mariano ER, Lehr MK, Loland VJ, Bishop ML. Choice of loco-regional anesthetic technique affects operating room efficiency for carpal tunnel release. J Anesth. 2013 Aug;27(4):611-4. doi: 10.1007/s00540-013-1578-8. Epub 2013 Mar 5.

  PMID: 23460418 BACKGROUND

• Soberon JR Jr, Crookshank JW 3rd, Nossaman BD, Elliott CE, Sisco-Wise LE, Duncan SF. Distal Peripheral Nerve Blocks in the Forearm as an Alternative to Proximal Brachial Plexus Blockade in Patients Undergoing Hand Surgery: A Prospective and Randomized Pilot Study. J Hand Surg Am. 2016 Oct;41(10):969-977. doi: 10.1016/j.jhsa.2016.07.092. Epub 2016 Aug 11.

  PMID: 27524691 BACKGROUND

• Jalil H, Polfliet F, Nijs K, Bruckers L, De Wachter G, Callebaut I, Salimans L, Van de Velde M, Stessel B. Efficacy of ultrasound-guided forearm nerve block versus forearm intravenous regional anaesthesia in patients undergoing carpal tunnel release: A randomized controlled trial. PLoS One. 2021 Feb 19;16(2):e0246863. doi: 10.1371/journal.pone.0246863. eCollection 2021.

  PMID: 33606754 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Björn Stessel, MD, PhD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 26, 2018
• Study Start: January 17, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)