Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628882
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
Comparison of Infraclavicular Block and Wide-Awake Local Anesthesia With No Tourniquet for Hand Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Infraclavicular Block and Wide-Awake Local Anesthesia With No Tourniquet for Hand Surgery A Prospective Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mg1 mL epinephrine 2 lidocaine 39 cc of 09 isotonic NaCl 10 mL of 84 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 mgkg 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 05 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
WALANT The WALANT solution was prepared as follows 50 mL of 1 mg1 mL epinephrine 2 lidocaine 39 cc of 09 isotonic NaCl 10 mL of 84 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 mgkg 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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None