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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Arm Injury
• Intervention / Treatment: Procedure: Upper extremity surgery under general anaesthesia; Procedure: Upper extremity surgery under regional anaesthesia

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert G Almasi, PhD.Habil.; Phone Number: +36304294450; Email: almasi.robert@pte.hu
• Study Contact Backup: Name: Erika Pintér, DSC., Prof; Phone Number: +36204338395; Email: erika.pinter@aok.pte.hu

Study Locations

• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7632
      • Recruiting
      • University of Pécs, Medical School
      • Contact: Robert Almasi, PhD. habil; Phone Number: +36304294450; Email: robert.almasi@pte.hu
      • Contact: Lajos Bogar, Prof. DSC; Phone Number: 32420 +3672535832; Email: bogar.lajos@pte.hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Upper extremity surgery under general anaesthesia; Fentanyl 2 mcg/kg iv, propofol 2 mg/kg iv induction, 1MAC sevoflurane maintenance	Procedure: Upper extremity surgery under general anaesthesia; Forearm, wrist and hand surgery after fentanyl and propofol induction of anaesthesia, with sevoflurane maintenance
Active Comparator: Upper extremity surgery under regional anaesthesia; Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Somatostatin concentration in plasma	Plasma concentrations of somatostatin straight after and 6 hours after surgery.	0-6 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endocannabinoid concentrations in plasma	Plasma concentrations of endocannabinoids straight after and 6 hours after surgery.	0-6 hours
Corticosteroid concentrations in plasma	Plasma concentrations of corticosteroids straight after and 6 hours after surgery.	0-6 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity: verbal numeric rate scale	Postoperative pain intensity in a 0-10 point verbal numeric rate scale	0-24 hours

Collaborators and Investigators

• Sponsor: University of Pecs
• Investigators: Study Chair: Robert G Almasi, PhD.Habil., University of Pecs, Medical School, Clinical Centre, Pain Medicine Dept.of Anesth Int Care; Principal Investigator: Zsofia Kriszta, MD., University of Pecs, Medical School, Clinical Centre, Dept.of Anesth Int Care

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Anticipated): November 20, 2021
• Study Completion (Anticipated): January 10, 2022

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 7726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No