Plasma Concentration of Somatostatin and Endocannabinoids After GA and RA in Upper Extremity Trauma Surgery
NCT ID: NCT04040738
Last Updated: 2021-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-11-05
2022-01-10
Brief Summary
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Detailed Description
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Standardized UG Axillary-supraclavicular (AX-SC) approach to the BP is planned to be performed under sterile conditions, or standardized GA with propofol IV, fentanyl IV, and 1 MAC (minimal alveolar concentration) sevoflurane, by experienced anesthesiologists.
Blood samples will be taken at 0-time point (straight before the administration of BP injection or the induction of GA) and straight after the surgery. The collected serum samples are stored at -70 °C for a maximum of two weeks prior to analysis. Qualitative and quantitative determination of endocannabinoids and corticosteroids is performed by supercritical fluid chromatography coupled with tandem mass spectrometry after salting-out assisted liquid-liquid microextraction. For somatostatin measurement, the samples are immediately supplemented with aprotinin (20µl/ml blood sample; Gordox 10 KIU/ml (Kallikrein Inhibitor Unit/ml), Richter Gedeon Budapest, Hungary) and transported for centrifugation on ice. The pellet is discarded, and the plasma is stored at -80⁰C until further processing. The somatostatin concentration of the plasma sample is determined with both ELISA (CEA592Hu, Cloud-Clone Corp., Wuhan, PRC) and radioimmunoassay. The results are collected and analyzed.
Demographic data, vital parameters, and verbal numeric rate of pain intensity are collected prior to and after surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Upper extremity surgery under general anaesthesia
Fentanyl 2 mcg/kg iv, propofol 2 mg/kg iv induction, 1MAC sevoflurane maintenance
Upper extremity surgery under general anaesthesia
Forearm, wrist and hand surgery after fentanyl and propofol induction of anaesthesia, with sevoflurane maintenance
Upper extremity surgery under regional anaesthesia
Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution
Upper extremity surgery under regional anaesthesia
Forearm, wrist and hand surgery under brachial plexus block with 0.4 ml/kg of 0.33% bupivacaine solution Other Names: Marcaine 5 mg/ml Astra Zeneca OGYI-T 6496/14
Interventions
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Upper extremity surgery under general anaesthesia
Forearm, wrist and hand surgery after fentanyl and propofol induction of anaesthesia, with sevoflurane maintenance
Upper extremity surgery under regional anaesthesia
Forearm, wrist and hand surgery under brachial plexus block with 0.4 ml/kg of 0.33% bupivacaine solution Other Names: Marcaine 5 mg/ml Astra Zeneca OGYI-T 6496/14
Eligibility Criteria
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Inclusion Criteria
* surgery of hand/forearm or upper arm
* unpremedicated patients
* scheduled for elective or emergency trauma
Exclusion Criteria
* the patient refused to participate
* preexisting chronic pain condition
* daily analgesic or sedative or steroid consumption
* sedative or analgesic premedication
* pre-existing neuro-endocrine disorders
* antecedent cancer
* advanced liver or kidney disease.
18 Years
70 Years
ALL
No
Sponsors
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University of Pecs
OTHER
Responsible Party
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Principal Investigators
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Robert G Almasi, PhD.Habil.
Role: STUDY_CHAIR
University of Pecs, Medical School, Clinical Centre, Pain Medicine Dept.of Anesth Int Care
Zsofia Kriszta, MD.
Role: PRINCIPAL_INVESTIGATOR
University of Pecs, Medical School, Clinical Centre, Dept.of Anesth Int Care
Locations
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University of Pécs, Medical School
Pécs, Baranya, Hungary
Countries
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Central Contacts
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Facility Contacts
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Robert Almasi, PhD. habil
Role: primary
Lajos Bogar, Prof. DSC
Role: backup
Other Identifiers
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7726
Identifier Type: -
Identifier Source: org_study_id