Clinical trial NCT06628882: Comparison of Infraclavicular Block and Wide-Awake Local Anesthesia With No Tourniquet for Hand Surgery
Official title: Comparison of Infraclavicular Block and Wide-Awake Local Anesthesia With No Tourniquet for Hand Surgery: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Hand Deformity
Keywords: hand surgery
Anesthesia
WALANT
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criterias:

* 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.

Exclusion Criterias:

* 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

Primary outcomes:
measure: the visual analog scale (VAS)
timeFrame: before surgery
measure: the visual analog scale (VAS)
timeFrame: during surgery
measure: the visual analog scale (VAS)
timeFrame: after surgery (Day 1)
Secondary outcomes:
measure: Likert scale(0-5 points)
timeFrame: after surgery (Day 0)
measure: Likert scale(0-5 points)
timeFrame: after surgery (Day 1)
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Uludag University
Study officials:
References: