Clinical trial NCT04040738: Plasma Concentration of Somatostatin and Endocannabinoids After GA and RA in Upper Extremity Trauma Surgery
Official title: Comparative Measurement of the Concentration of Blood Somatostatin and Fatty Amid Acids in Upper Extremity Trauma Surgery Under General and Regional Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Arm Injury
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants n=25 in the S-GA, n=25 in the S-RA, n=25 in the H-GA, and n=25 in the H-RA Groups.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* upper extremity fracture
* surgery of hand/forearm or upper arm
* unpremedicated patients
* scheduled for elective or emergency trauma

Exclusion Criteria:

* psycho-mental conditions interfering with consent or assessment
* 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.

Primary outcomes:
measure: Somatostatin concentration in plasma
timeFrame: 0-6 hours after surgery
Secondary outcomes:
measure: Endocannabinoid concentrations in plasma
timeFrame: 0-6 hours
measure: Corticosteroid concentrations in plasma
timeFrame: 0-6 hours
Other outcomes:
measure: Postoperative pain intensity: verbal numeric rate scale
timeFrame: 0-24 hours
Locations:
city: Pécs
country: Hungary
facility: University of Pécs, Medical School
state: Baranya
Study officials:
affiliation: University of Pecs, Medical School, Clinical Centre, Pain Medicine Dept.of Anesth Int Care
name: Robert G Almasi, PhD.Habil.
role: STUDY_CHAIR
affiliation: University of Pecs, Medical School, Clinical Centre, Dept.of Anesth Int Care
name: Zsofia Kriszta, MD.
role: PRINCIPAL_INVESTIGATOR
References: