The Effect of Altitude Difference on the Duration of Nerve Block; A Three-Center Study.

NCT06027918 | Completed

• 1 other identifier: 12.09.2022/266
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Forearm Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively

Secondary Outcomes (5)

• total amount of intravenous analgesics consumed

  will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively

• Sensory block start time

  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

  It will be evaluated every hour after the implementation, up to a maximum of 120 hours.

• Time to onset of motor block

  Motor block onset time will be assessed every 10 minutes after the intervention until 60 minutes.

• Motor block end time

  It will be evaluated every hour after the implementation, up to a maximum of 120 hours.

Study Arms (3)

Group V (1726 meter altitude)

ACTIVE COMPARATOR

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

Group D (675 meter altitude)

ACTIVE COMPARATOR

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

Group H( 100 meter altitude)

ACTIVE COMPARATOR

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

Interventions

Infraclavicular brachial plexus block PROCEDURE

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); Group H( 100 meter altitude); Group V (1726 meter altitude)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18-55 years old
• Body mass index between 20 and 25
• Patients with American Society of Anesthesiologists classification (ASA) physical status I or II

You may not qualify if:

• Patients aged younger than 18 and older than 55 years
• American Society of Anesthesiologists classification (ASA) ≥ III
• Body mass index (BMI) \>35
• Known history of allergy to local anesthetics preoperative chronic pain and therefore long-term analgesic use
• In case of coagulopathy
• Have a condition that constitutes a contraindication for the application of the block (local infection, sepsis, local anesthetic medicine allergy; severe neurological, muscular or psychiatric disease, coagulation disorders)
• With marked cognitive impairment
• Patients who did not want to participate in the study.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Location

Related Publications (1)

• Harmon D, Frizelle HP. Supraclavicular block for day-case anaesthesia at altitude. Anaesthesia. 2001 Feb;56(2):197. doi: 10.1046/j.1365-2044.2001.01870-30.x. No abstract available.

  PMID: 11167511 BACKGROUND

Study Officials

• Cem K. Kaçar, Assoc.Prof

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 7, 2023
• Study Start: October 3, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 16, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

TU (1)