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

NCT ID: NCT06628882

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-07
• Study Completion Date: 2023-05-31

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.

Conditions

Anesthesia, Local; Hand Deformity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Infraclavicular Block

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.

Group Type: ACTIVE_COMPARATOR

Infraclavicular Block

Intervention Type: PROCEDURE

types of anesthesia used in upper extremity surgeries

Wide-Awake Local Anesthesia with No Tourniquet

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.

Group Type: EXPERIMENTAL

Wide-Awake Local Anesthesia with No Tourniquet

Intervention Type: PROCEDURE

types of anesthesia used in upper extremity surgeries

Interventions

Infraclavicular Block

types of anesthesia used in upper extremity surgeries

Intervention Type: PROCEDURE

Wide-Awake Local Anesthesia with No Tourniquet

types of anesthesia used in upper extremity surgeries

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uludag University

OTHER

Sponsor Role: lead

Responsible Party

Selcan Akesen

Anesthesiology and Reanimation Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bursa Uludag University

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022-19/21

Identifier Type: -

Identifier Source: org_study_id