An interventional study of Infraclavicular brachial plexus block in Forearm Surgery, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Not applicable, Interventional, and Prevention
Infraclavicular brachial plexus block in hand and forearm surgery has the advantages of high success rate and low risk of complications and is useful in providing long-lasting and effective postoperative analgesia in these patients. In response to hypoxemia at high altitude, increased blood viscosity, decreased carbon monoxide diffusion capacity, increased cerebral arterial blood flow, decreased blood volume and decreased cardiac output occur. At high altitude, the serum level of local anesthetics may increase due to an increase in their ionized fraction and a decrease in their clearance. In this respect, the pharmacodynamic and pharmacokinetic properties of peripheral nerve blocks may be altered when performed at high altitude. The primary objective of this prospective study was to test the hypothesis that postoperative pain scores are higher in patients undergoing infraclavicular nerve block at high altitude than in patients at low altitude.
This multicenter prospective randomized study will be initiated after approval of the Ethics Committee of Health ScienceUniversity Diyarbakir Gazi Yasargil Training and Research Hospital. Patients will be recruited simultaneously in 3 hospitals, Hatay Training and Research Hospital, Hatay, Turkey (100 m above sea level);Health Science Health Science University Diyarbakir Gazi Yasargil Training and Research Hospital, Diyarbakir, Turkey (675 m above sea level) and Health Science University Van Regional and Training Research Hospital, Van, Turkey (1726 m above sea level).
Infraclavicular brachial plexus blocks (coracoid approach) will be performed by administering a local anesthetic mixture of 1.5 mg/kg lidocaine 2% + 1 mg/kg bupivacaine 0.5% at the 6 o'clock position of the axillary artery under US guidance.
Group V (1726 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
Group D (675 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5 mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
Comparator / control treatment Group H (100 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5 mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 56 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance. The block will be applied only once, approximately 15-20 minutes before surgery.
Procedure: Infraclavicular brachial plexus block
In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance. The block will be applied only once, approximately 15-20 minutes before surgery.
Procedure: Infraclavicular brachial plexus block
In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance. The block will be applied only once, approximately 15-20 minutes before surgery.
Procedure: Infraclavicular brachial plexus block
In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
Visual Analogue Scale (VAS)
* The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." * Pain intensity at the site of the operation.
Time frame: will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively
total amount of intravenous analgesics consumed
to be evaluated at the end of 24 hours postoperatively
Time frame: will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively
Sensory block start time
The onset time of sensory block was defined as the time to reach an absence of hot-cold sensation in all 4 nerve distributions after completion of injection of the local anesthetic mixture. Sensory block was assessed using the cold test on the dermatomes of the median, ulnar, radial and musculocutaneous nerves. Sensory block was graded on a 3-point scale (0: normal sensation, 1: analgesia \[patient can feel touch but not cold\], 2: anesthesia \[patient cannot even feel touch\]).
Time frame: The sensory block will be evaluated approximately 10 minutes after the application. It will be observed up to a maximum of 30 minutes.
sensory block end time
Sensory block end time: defined as the time when the hot-cold sensation disappears in all 4 nerve distributions after the injection of the local anesthetic mixture is completed.
Time frame: It will be evaluated every hour after the implementation, up to a maximum of 120 hours.
Time to onset of motor block
Time to onset of motor block, the time from the completion of injection of the local anesthetic mixture until complete motor block develops (in case of bromage : 4). Motor block was assessed with the Modified Bromage scale (scale 0: full flexion of the fingers, wrist and elbow; scale 1: full flexion of the fingers and wrist, but no flexion of the elbow); scale 2: full flexion of the fingers, but no flexion of the wrist and elbow; scale 3: complete motor block; no flexion of the fingers, wrist and elbow).
Time frame: Motor block onset time will be assessed every 10 minutes after the intervention until 60 minutes.
Motor block end time
Motor block was assessed with the Modified Bromage scale (scale 0: full flexion of the fingers, wrist and elbow; scale 1: full flexion of the fingers and wrist, but no flexion of the elbow); scale 2: full flexion of the fingers, but no flexion of the wrist and elbow; scale 3: complete motor block; no flexion of the fingers, wrist and elbow). If the bromage is 0, the motor block will be considered as eliminated.
Time frame: It will be evaluated every hour after the implementation, up to a maximum of 120 hours.
Plan to share: Undecided
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital