Effect of Local Anaesthetic Volume on Axillary Brachial Plexus Block Duration

NCT03163472 | Completed Results

• 1 other identifier: ECM 4 (J)
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Axillary brachial plexus block is an safe, effective and widely used technique for providing surgical anesthesia at and below the elbow. Inadvertent intraneural and intravascular injections are the only significant risks. Traditionally, greater volumes of local anaesthetic have been administered to achieve successful axillary brachial plexus block, but recent studies have demonstrated that this can be achieved with even very low volumes of 2-4 mL lidocaine 1.5% per nerve or ultra low volume of 1 mL lidocaine 2% per nerve. Administration of 30mL (vs 10 mL) lidocaine 2% with epinephrine 1:200 000 prolongs the sensory and motor block duration of ultrasound guided axillary brachial plexus block for elective upper limb surgical procedures. Primary Outcome: The primary outcome will be the overall duration of sensory block. Secondary Outcomes: Duration of motor block Time to onset of the block. The quality of block intraoperatively Time to first request of postoperative opioid analgesia. Total opioid consumption at 24 hours. The incidence of adverse effects perioperatively: nausea, dizziness, tinnitus, vomiting, convulsions or arrhythmia.

Conditions

Brachial Plexus Blockade

Outcome Measures

Primary Outcomes (1)

• Overall Duration of Sensory Block.

  Duration of sensory block of ultrasound guided brachial plexus block

  24 hours

Secondary Outcomes (5)

• Duration of Motor Block

  24 hours

• Time to Onset of the Block

  6 hours

• Time to First Request of Postoperative Opioid Analgesia

  24 hours

• Opioid Consumption

  24 hours

• Number of Participants With Adverse Effects Perioperatively: Nausea, Dizziness, Tinnitus, Vomiting, Convulsions or Arrhythmia"

  24 hours

Study Arms (2)

10 ml of lidocaine 2% with epinephrine

ACTIVE COMPARATOR

patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.

Procedure: Axillary brachial plexus block with 10 mL oof local anaesthetic

30ml of lidocaine 2% with epinephrine

EXPERIMENTAL

patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.

Procedure: Axillary brachial plexus block with 30 ml of local anaesthetic

Interventions

Axillary brachial plexus block with 10 mL oof local anaesthetic PROCEDURE

patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.

10 ml of lidocaine 2% with epinephrine

Axillary brachial plexus block with 30 ml of local anaesthetic PROCEDURE

patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.

30ml of lidocaine 2% with epinephrine

Eligibility Criteria

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

You may qualify if:

• ASA 1-3
• Patients aged \>18 years
• undergoing elective upper limb (forearm, wrist or hand) surgical procedures.

You may not qualify if:

• Contraindications to regional anaesthesia
• Hypersensitivity to amide local anaesthetics.
• Chronic pain
• Language barrier
• Neuromuscular disorders or peripheral neuropathy
• Body mass index \> 35
• History of hepatic and renal insufficiency
• Pregnancy
• Cognitive or psychiatric disorder
• Cardiac conduction abnormality.

Sponsors & Collaborators

• Cork University Hospital: lead

MeSH Terms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr Anil Ranganath
• Organization: Cork University Hospital

drmrak.2@gmail.com

Study Officials

• Anil Ranganath, FCAI

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr (Fellow in Regional Anaesthesia)

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 23, 2017
• Study Start: November 14, 2012
• Primary Completion: August 7, 2013
• Study Completion: August 7, 2013
• Last Updated: October 4, 2021
• Results First Posted: August 31, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share