Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04040738 |
Other study ID # |
7726 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 5, 2019 |
Est. completion date |
January 10, 2022 |
Study information
Verified date |
November 2021 |
Source |
University of Pecs |
Contact |
Robert G Almasi, PhD.Habil. |
Phone |
+36304294450 |
Email |
almasi.robert[@]pte.hu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The application of RA can decrease the central sensitization and chronic pain after trauma
surgery. The plasma concentrations of somatostatin and fatty acid amides were not studied up
to this time in this kind of settings, so investigators believe that this is the first work
that shows how upper extremity nerve blockade changes the plasma concentration of
somatostatin and fatty acid amides in upper limb surgery in trauma patients.
Description:
Total of 100 American Society of Anesthesiologist (ASA) I-III, adult patients scheduled to
elective or emergency trauma surgery of hand/forearm or shoulder are planned to be randomly
allocated to general anaesthesia (GA) or ultrasound-guided (UG) brachial plexus block (BPB)
group, in this randomized-prospective study after approval by the University Research Ethics
Board, Pécs University Medical School, Hungary. All of the patients will receive detailed
information about the planned BPB or GA techniques and surgeries, then written informed
consents will be obtained. Study participants are planned to be assigned randomly into 4
groups (Shoulder GA; Shoulder RA; Hand/forearm GA; Hand/forearm RA).
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.