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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 10, 2022
Est. primary completion date November 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Hungary University of Pécs, Medical School Pécs Baranya

Sponsors (1)

Lead Sponsor Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Other Postoperative pain intensity: verbal numeric rate scale Postoperative pain intensity in a 0-10 point verbal numeric rate scale 0-24 hours
Primary Somatostatin concentration in plasma Plasma concentrations of somatostatin straight after and 6 hours after surgery. 0-6 hours after surgery
Secondary Endocannabinoid concentrations in plasma Plasma concentrations of endocannabinoids straight after and 6 hours after surgery. 0-6 hours
Secondary Corticosteroid concentrations in plasma Plasma concentrations of corticosteroids straight after and 6 hours after surgery. 0-6 hours
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