Plasma Concentration of Somatostatin and Endocannabinoids After GA and RA in Upper Extremity Trauma Surgery (SECsGRUES)
Primary Purpose
Postoperative Pain, Arm Injury
Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Upper extremity surgery under general anaesthesia
Upper extremity surgery under regional anaesthesia
Sponsored by
About this trial
This is an interventional basic science trial for Postoperative Pain
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.
Sites / Locations
- University of Pécs, Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Upper extremity surgery under general anaesthesia
Upper extremity surgery under regional anaesthesia
Arm Description
Fentanyl 2 mcg/kg iv, propofol 2 mg/kg iv induction, 1MAC sevoflurane maintenance
Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution
Outcomes
Primary Outcome Measures
Somatostatin concentration in plasma
Plasma concentrations of somatostatin straight after and 6 hours after surgery.
Secondary Outcome Measures
Endocannabinoid concentrations in plasma
Plasma concentrations of endocannabinoids straight after and 6 hours after surgery.
Corticosteroid concentrations in plasma
Plasma concentrations of corticosteroids straight after and 6 hours after surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04040738
Brief Title
Plasma Concentration of Somatostatin and Endocannabinoids After GA and RA in Upper Extremity Trauma Surgery
Acronym
SECsGRUES
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
November 20, 2021 (Anticipated)
Study Completion Date
January 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pecs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Arm Injury
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
The labour analyst, the investigator, the statistician is unaware of group allocation.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Upper extremity surgery under general anaesthesia
Arm Type
Active Comparator
Arm Description
Fentanyl 2 mcg/kg iv, propofol 2 mg/kg iv induction, 1MAC sevoflurane maintenance
Arm Title
Upper extremity surgery under regional anaesthesia
Arm Type
Active Comparator
Arm Description
Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution
Intervention Type
Procedure
Intervention Name(s)
Upper extremity surgery under general anaesthesia
Intervention Description
Forearm, wrist and hand surgery after fentanyl and propofol induction of anaesthesia, with sevoflurane maintenance
Intervention Type
Procedure
Intervention Name(s)
Upper extremity surgery under regional anaesthesia
Intervention Description
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
Primary Outcome Measure Information:
Title
Somatostatin concentration in plasma
Description
Plasma concentrations of somatostatin straight after and 6 hours after surgery.
Time Frame
0-6 hours after surgery
Secondary Outcome Measure Information:
Title
Endocannabinoid concentrations in plasma
Description
Plasma concentrations of endocannabinoids straight after and 6 hours after surgery.
Time Frame
0-6 hours
Title
Corticosteroid concentrations in plasma
Description
Plasma concentrations of corticosteroids straight after and 6 hours after surgery.
Time Frame
0-6 hours
Other Pre-specified Outcome Measures:
Title
Postoperative pain intensity: verbal numeric rate scale
Description
Postoperative pain intensity in a 0-10 point verbal numeric rate scale
Time Frame
0-24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert G Almasi, PhD.Habil.
Phone
+36304294450
Email
almasi.robert@pte.hu
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Pintér, DSC., Prof
Phone
+36204338395
Email
erika.pinter@aok.pte.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Almasi, PhD.Habil.
Organizational Affiliation
University of Pecs, Medical School, Clinical Centre, Pain Medicine Dept.of Anesth Int Care
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zsofia Kriszta, MD.
Organizational Affiliation
University of Pecs, Medical School, Clinical Centre, Dept.of Anesth Int Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pécs, Medical School
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7632
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Almasi, PhD. habil
Phone
+36304294450
Email
robert.almasi@pte.hu
First Name & Middle Initial & Last Name & Degree
Lajos Bogar, Prof. DSC
Phone
+3672535832
Ext
32420
Email
bogar.lajos@pte.hu
12. IPD Sharing Statement
Plan to Share IPD
No
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Plasma Concentration of Somatostatin and Endocannabinoids After GA and RA in Upper Extremity Trauma Surgery
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