Comparison of Infraclavicular Block and Wide-Awake Local Anesthesia With No Tourniquet for Hand Surgery

NCT06628882 | Completed

• 1 other identifier: 2022-19/21
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The patients were randomized into the WALANT and ICB groups. The pain levels of the patients before, during, and after surgery were queried and recorded using the visual analog scale (VAS). Their satisfaction levels were evaluated using a Likert scale. The duration of anesthesia administration, onset of the anesthesia effect, additional intraoperative analgesic needs, total duration of the anesthesia effect, postoperative analgesic needs, length of hospital stay, total surgical duration, hospitalization costs, and complications were evaluated.

Conditions

Anesthesia, Local; Hand Deformity

Keywords

hand surgery; Anesthesia; WALANT

Outcome Measures

Primary Outcomes (3)

• the visual analog scale (VAS)

  pain score - (0-10 point - higher scores mean worse)

  before surgery

• the visual analog scale (VAS)

  pain score - (0-10 point - higher scores mean worse)

  during surgery

• the visual analog scale (VAS)

  pain score - (0-10 point - higher scores mean worse)

  after surgery (Day 1)

Secondary Outcomes (2)

• Likert scale(0-5 points)

  after surgery (Day 0)

• Likert scale(0-5 points)

  after surgery (Day 1)

Study Arms (2)

Infraclavicular Block

ACTIVE COMPARATOR

Patients were placed in the supine position with the head facing the opposite direction of the blocked side .After sterilizing the skin with povidone iodine, a linear ultrasound probe was sterilized and placed vertically over the infraclavicular fossa to visualize the axillary artery and the lateral, medial, and posterior cords of the brachial plexus. Using an 80 mm long 21G Stimuplex1 needle, a mixture of 10 cc 0.5% bupivacaine (BUPIVON® liquid 5%, On Pharma, Istanbul, Turkey)and 2% lidocaine(JETOKAIN® liquid Adeka Pharma, Istanbul, Turkey) was injected around the three cords with intermittent aspiration for control purposes.

Procedure: Infraclavicular Block

Wide-Awake Local Anesthesia with No Tourniquet

EXPERIMENTAL

The WALANT solution was prepared as follows: 50 mL of 1 mg/1 mL epinephrine + 2% lidocaine(JETOKAIN® liquid Adeka Pharma, Istanbul, Turkey) + 39 cc of 0.9% isotonic NaCl + 10 mL of 8.4% sodium bicarbonate . The surgical area was sterilized with polyvinyl iodine. Using a 27-gauge syringe, the solution was applied around the incision site, either from a single point or several different points, until whitening of the skin was observed. Care was taken not to exceed the maximum dose of 7 mg/kg. The surgical procedure began 20-30 minutes after the application of the WALANT technique.

Procedure: Wide-Awake Local Anesthesia with No Tourniquet

Interventions

Infraclavicular Block PROCEDURE

types of anesthesia used in upper extremity surgeries

Infraclavicular Block

Wide-Awake Local Anesthesia with No Tourniquet PROCEDURE

types of anesthesia used in upper extremity surgeries

Wide-Awake Local Anesthesia with No Tourniquet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status classification of I, II, or III,
• surgery planned for a single indication
• surgery duration of between 20 and 60 minutes.

You may not qualify if:

• patients with an ASA classification \>III,
• patients with planned bilateral surgery,
• patients with a local infection,
• patients with a neurological disorder affecting the same upper extremity,
• patients with a history of allergy to local anesthetic drugs,
• patients with a history of opioid use in the previous month,
• patients who were unable to understand the study and answer the questions adequately

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hand Deformities

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: October 8, 2024
• Study Start: December 7, 2022
• Primary Completion: May 19, 2023
• Study Completion: May 31, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)