Bier's Block Versus Mini-bier's Block in Patients Undergoing Hand Surgery

NCT03761329 | Completed

• 1 other identifier: 18.46/ANESTH18.03
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

By means of an observer-blinded, randomized controlled trial, the analgesic efficacy of an upper-arm Bier's block and a forearm mini-Bier's block will be investigated in patients undergoing hand surgery. The hypothesis is that there is no difference between the two types of anesthetic techniques with respect to the analgesic efficacy.

Conditions

Surgery; Anesthesia, Local

Keywords

Anesthesia; Bier's block; Mini-Bier's block; Hand surgery

Outcome Measures

Primary Outcomes (1)

• Sensory and motor block of the hand

  This study wants to evaluate and compare the analgesic efficacy of the Bier's block with the mini-Bier's 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.

  5 minutes after injection of lidocaine 0.5%

Secondary Outcomes (11)

• Pre-operative pain score: Numeric Rating Scale (NRS)

  Before the start of anesthesia technique

• Pain due to anesthesia technique: Numeric Rating Scale (NRS)

  At the end of performing the anesthesia technique

• Tourniquet time

  From start of inflation until deflation of the tourniquet

• Onset time of analgesia

  At injection of the anaesthetic until complete blockade of the sensory nerves

• Tourniquet tolerance time

  From start of inflation until deflation of the tourniquet

Study Arms (2)

Bier's block

ACTIVE COMPARATOR

Upperarm intravenous regional anesthesia (Bier's block) with lidocaine 0.5% 40ml

Procedure: Conventional Bier's block with lidocaine 0.5% 40ml

Mini-Bier's block

EXPERIMENTAL

Forearm intravenous regional anesthesia (mini-Bier's block) with lidocaine 0.5% 25ml

Procedure: mini-Bier's block with lidocaine 0.5% 25ml

Interventions

mini-Bier's block with lidocaine 0.5% 25ml PROCEDURE

An intravenous catheter will be placed in the dorsal vein of the hand that will undergo surgery. Afterwards, a tourniquet will be placed on the forearm and inflated, after which the anesthetic can be administered via the dorsal vein catheter (25ml lidocaine 0.5%). The tourniquet remains inflated for 10 minutes to reduce systemic toxicity reactions postoperatively.

Also known as: forearm intravenous regional anesthesia (IVRA)

Mini-Bier's block

Conventional Bier's block with lidocaine 0.5% 40ml PROCEDURE

An intravenous catheter will be placed in the dorsal vein of the hand that will undergo surgery. Afterwards, a tourniquet will be placed on the upper arm and inflated, after which the anesthetic can be administered via the dorsal vein catheter (40ml Lidocaine 0.5%). The tourniquet remains inflated for 25 minutes to reduce systemic toxicity reactions postoperatively.

Also known as: Upperarm intravenous regional anesthesia (IVRA)

Bier's 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 hand surgery which can be performed using either a Bier's block or a mini-Bier's block

You may not qualify if:

• \< 18 years old
• Patients that participate in other clinical, pharmaceutical trials or trials with medical devices
• Patients that previously have been randomized in this trial
• Patients that need to undergo surgery using sedation/general anesthesia
• Bilateral surgery
• BMI ≥ 40 kg/m2
• History of neurological conditions
• Chronic pain symptoms
• Concomitant use of Opioids in the last month
• Diabetes mellitus with organ damage
• Oversensitivity to local anesthetics
• Blood clotting disorders
• 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 (5)

• Chiao FB, Chen J, Lesser JB, Resta-Flarer F, Bennett H. Single-cuff forearm tourniquet in intravenous regional anaesthesia results in less pain and fewer sedation requirements than upper arm tourniquet. Br J Anaesth. 2013 Aug;111(2):271-5. doi: 10.1093/bja/aet032. Epub 2013 Mar 18.

  PMID: 23508563 BACKGROUND

• Guay J. Adverse events associated with intravenous regional anesthesia (Bier block): a systematic review of complications. J Clin Anesth. 2009 Dec;21(8):585-94. doi: 10.1016/j.jclinane.2009.01.015.

  PMID: 20122591 BACKGROUND

• Arslanian B, Mehrzad R, Kramer T, Kim DC. Forearm Bier block: a new regional anesthetic technique for upper extremity surgery. Ann Plast Surg. 2014 Aug;73(2):156-7. doi: 10.1097/SAP.0b013e318276da4c.

  PMID: 23407261 BACKGROUND

• Karalezli N, Karalezli K, Iltar S, Cimen O, Aydogan N. Results of intravenous regional anaesthesia with distal forearm application. Acta Orthop Belg. 2004 Oct;70(5):401-5.

  PMID: 15587026 BACKGROUND

• Chong AK, Tan DM, Ooi BS, Mahadevan M, Lim AY, Lim BH. Comparison of forearm and conventional Bier's blocks for manipulation and reduction of distal radius fractures. J Hand Surg Eur Vol. 2007 Feb;32(1):57-9. doi: 10.1016/j.jhsb.2006.10.002. Epub 2006 Nov 22.

  PMID: 17123673 BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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: October 16, 2018
• First Posted: December 3, 2018
• Study Start: November 12, 2018
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)