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

Bursa Uludag University

Status: Completed

Conditions: Anesthesia, Local; Hand Deformity

Treatments: Procedure: Infraclavicular Block; Procedure: Wide-Awake Local Anesthesia with No Tourniquet

Study type: Interventional

Funder types: Other

Identifiers

NCT06628882

2022-19/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Infraclavicular Block

Active Comparator group

Description:

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.

Treatment:

Procedure: Infraclavicular Block

Wide-Awake Local Anesthesia with No Tourniquet

Experimental group

Description:

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.

Treatment:

Procedure: Wide-Awake Local Anesthesia with No Tourniquet