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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04921891
Other study ID # 2014-86
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2014
Est. completion date October 30, 2014

Study information

Verified date June 2021
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries, provides additional advantages such as reduction in opioid consumption by providing analgesic effect in the postoperative period as welll. The success of peripheral nerve blocks is usually assessed by subjective feedback from the patient, and patient cooperation is needed. The aim of this study is to assess whether the perfusion index level, which can be measured noninvasively, can be a predictor of the infraclavicular block success.


Description:

Thirty patients who were operated on for carpal tunnel syndrome under infraclavicular brachial plexus block were included in our study. After the procedure, at 10-minute intervals, the sensory block was assessed by a pinprick test, and the motor block was assessed by the ability to flex the hand and the forearm. In addition, PI and skin temperature were measured 0-10-20-30 minutes after the block and at postoperative 2, 4, and 6 hours. 30 minutes after the measurements, the surgical procedure was allowed to begin in patients with successful block.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 30, 2014
Est. primary completion date April 15, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Ages of 18-75 - Patients who will diagnose with carpal tunnel syndrome by electroneuromyography (ENMG), and will undergo unilateral surgery under elective conditions - ASA I-II-III patients Exclusion Criteria: - Patients who will refuse this method - Neurological deficits, - Diabetes mellitus, - Local anesthetic allergy, - Morbidly obese, - Peripheral vascular disease, coronary artery disease, or coagulopathy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Infraclavicular nerve block
The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.
Without nerve block
The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.

Locations

Country Name City State
Turkey Bakirkoy Dr. Sadi Konuk Research and Training Hospital Istanbul Bakirkoy

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of whether perfusion index is a reliable and objective method to indicate block success Perfusion index was measured up to 6 hours after the procedure. 6 hours postprocedurly
Secondary Determining of a cut-off value for PI and PI ratio for a successful block. There may be changes in the cut-off value depending on the applied plexus area, local anesthesia, volume and concentration of LA and the applied assistive technique (ultrasound or nerve stimulator). For both this reason and due to the high variability in the PI values, the PI ratio was calculated to predict block success. Up to 6 hours after the procedure
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