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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06004648
Other study ID # 107
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 28, 2022
Est. completion date January 10, 2023

Study information

Verified date August 2023
Source Gaziosmanpasa Research and Education Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There are different methods in brachial plexus blocks for hand, wrist, forearm, and elbow operations. In this study, the anesthetic efficacy of the ultrasound-guided selective truncus methods and the supraclavicular methods for brachial plexus blocks in upper extremity surgeries will be compared.


Description:

Currently, brachial plexus block performed with various approaches is preferred to general anesthesia due to its advantages in upper extremity surgeries. These advantages can be listed as protecting the patient's consciousness, minimum effect on breathing, reducing airway interventions, enabling long-term postoperative pain control, reducing opioid-related side effects, limiting metabolic and endocrine changes due to surgery, and early discharge of hospital. The supraclavicular approach has a rapid onset of block and a high success rate. Close proximity to the pleura is the main disadvantage, but the widespread use of USG in peripheral blocks has also reduced the risk of complications related to this proximity. In the selective truncus approach defined by Manoj Kumar Karmakar in 2020, three trunks of the brachial plexus can be identified separately and selectively blocked under ultrasound guidance. It has been suggested that sensory/motor block occurs in all ipsilateral upper extremity dermatomes except T2 by selective blocking of the upper, middle, and lower trunks. In this study, the selective trunk method and the supraclavicular method will be compared. Patients who will undergo upper extremity elbow and below-elbow surgery in the orthopedics and traumatology operating room will be included in the study. The primary aim of the study is to compare the success rates of supraclavicular and selective truncus blocks in patients scheduled for hand, wrist, forearm, and elbow surgery. Comparisons will be made by measuring the first analgesic time after surgery. Secondary aims are sensory and motor block success rates between the two methods. The block application time, preparation time for surgery, number of needle insertions, tourniquet pain, diaphragmatic paralysis rate, complications (vascular puncture, paresthesia, horner's syndrome, hoarseness, local anesthetic toxicity, pneumothorax) patient satisfaction, surgeon satisfaction and total analgesic amount at the end of the postoperative 12 and 24 hours will be recorded.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date January 10, 2023
Est. primary completion date January 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients undergoing upper extremity elbow and below-elbow surgery in the orthopedics and traumatology operating room Exclusion Criteria: - Patient's refusal - ASA IV, - Pregnancy, - Neuromuscular disease, - Peripheral neuropathy - Bleeding disorders, - Local anesthetic allergy, - Infection in the block area - Operations without using a tourniquet

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Upper extremity surgery
Comparison of 2 different peripheral nerve blocks

Locations

Country Name City State
Turkey Zühal Çavus Istanbul Gaziosmanpasa

Sponsors (1)

Lead Sponsor Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary peripheral block success primary aim of the study is to compare the success rates of supraclavicular and selective truncus blocks in patients scheduled for hand, wrist, forearm, and elbow surgery. Comparison will be made by measuring the first analgesic time after surgery. T1: 12 hours after surgery, T2: 24 hours after surgery
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