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Plasma Concentration of Somatostatin and Endocannabinoids After GA and RA in Upper Extremity Trauma Surgery

Comparative Measurement of the Concentration of Blood Somatostatin and Fatty Amid Acids in Upper Extremity Trauma Surgery Under General and Regional Anesthesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04040738
Acronym
SECsGRUES
Enrollment
100
Registered
2019-08-01
Start date
2019-11-05
Completion date
2022-01-10
Last updated
2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arm Injury, Postoperative Pain

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.

Interventions

PROCEDUREUpper extremity surgery under general anaesthesia

Forearm, wrist and hand surgery after fentanyl and propofol induction of anaesthesia, with sevoflurane maintenance

PROCEDUREUpper 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

Sponsors

University of Pecs
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The labour analyst, the investigator, the statistician is unaware of group allocation.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Somatostatin concentration in plasma0-6 hours after surgeryPlasma concentrations of somatostatin straight after and 6 hours after surgery.

Secondary

MeasureTime frameDescription
Endocannabinoid concentrations in plasma0-6 hoursPlasma concentrations of endocannabinoids straight after and 6 hours after surgery.
Corticosteroid concentrations in plasma0-6 hoursPlasma concentrations of corticosteroids straight after and 6 hours after surgery.

Other

MeasureTime frameDescription
Postoperative pain intensity: verbal numeric rate scale0-24 hoursPostoperative pain intensity in a 0-10 point verbal numeric rate scale

Countries

Hungary

Contacts

Primary ContactRobert G Almasi, PhD.Habil.
almasi.robert@pte.hu+36304294450
Backup ContactErika Pintér, DSC., Prof
erika.pinter@aok.pte.hu+36204338395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026