AzTrials
AzTrials

Anesthesia, LocalNCT06628882

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

A study testing Infraclavicular Block and Wide-Awake Local Anesthesia with No Tourniquet in people with Anesthesia, Local and Hand Deformity, run by Uludag University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anesthesia, Local, Hand Deformity
What is being tested?
Infraclavicular Block and Wide-Awake Local Anesthesia with No Tourniquet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Dec 2022to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bursa Uludag University

    Bursa

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Infraclavicular Block and Wide-Awake Local Anesthesia With No Tourniquet for Hand Surgery: A Prospective Randomized Controlled Study

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.

Read the detailed description

The inclusion criteria were patients between the ages of 18 and 70, an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III, surgery planned for a single indication, and a surgery duration of between 20 and 60 minutes. The exclusion criteria were 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, and patients who were unable to understand the study and answer the questions adequately.

WALANT: The WALANT solution was prepared as follows: 50 mL of 1 mg/1 mL epinephrine + 2% lidocaine + 39 cc of 0.9% isotonic NaCl + 10 mL of 8.4% sodium bicarbonate [11]. 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. Figure 1 shows patients for whom the WALANT technique was administered..

ICB: 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 and 2% lidocaine was injected around the three cords with intermittent aspiration for control purposes. Figure 2 shows patients who underwent the ICB procedure.

Clinical evaluation: Patients who could not achieve sufficient pain control were either sedated or switched to general anesthesia and were excluded from the study. The pain levels of the patients before, during, and after surgery were queried and recorded using the visual analog scale (VAS). The patients were asked whether they would prefer the same anesthesia method if another surgery were planned, and their satisfaction levels were evaluated using a Likert scale, where 1 indicated low levels of satisfaction, and 4 denoted high levels of satisfaction. The duration of anesthesia administration, onset of the anesthesia effect, intraoperative additional analgesic needs, total duration of the anesthesia effect, postoperative analgesic needs, length of hospital stay, total surgical duration, and complications were evaluated. The hospitalization costs (including the cost of drugs and anesthesia materials) of the WALANT and ICB groups were calculated and compared.

Being tested
Infraclavicular Block, Wide-Awake Local Anesthesia with No Tourniquet
Keywords
hand surgery, Anesthesia, WALANT
Medical subject headings
Hand Deformities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infraclavicular BlockProcedure or surgery

    types of anesthesia used in upper extremity surgeries

  • Wide-Awake Local Anesthesia with No TourniquetProcedure or surgery

    types of anesthesia used in upper extremity surgeries

Study groups in NCT06628882
Study groupRoleWhat they receive
Infraclavicular BlockActive comparatorPatients 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.
Receives: Procedure: Infraclavicular Block
Wide-Awake Local Anesthesia with No TourniquetExperimentalThe 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.
Receives: Procedure: Wide-Awake Local Anesthesia with No Tourniquet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the visual analog scale (VAS)

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

    Measured: before surgery

  2. the visual analog scale (VAS)

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

    Measured: during surgery

  3. the visual analog scale (VAS)

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

    Measured: after surgery (Day 1)

Secondary outcomes (2)
  1. Likert scale(0-5 points)

    levels of satisfaction (0-5 point - higher scores mean better)

    Measured: after surgery (Day 0)

  2. Likert scale(0-5 points)

    levels of satisfaction (0-5 point - higher scores mean better)

    Measured: after surgery (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start7 Dec 2022
  3. Primary completion19 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06628882
Sponsor's protocol ID
2022-19/21
Status last verified
Oct 2024
First submitted
24 Jun 2024
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Infraclavicular Block and Wide-Awake Local Anesthesia with No Tourniquet in people with Anesthesia, Local and Hand Deformity, run by Uludag University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the visual analog scale (VAS) (time frame: before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in