Postoperative PainSECsGRUESNCT04040738
Plasma Concentration of Somatostatin and Endocannabinoids After GA and RA in Upper Extremity Trauma Surgery
A study testing Upper extremity surgery under general anaesthesia and Upper extremity surgery under regional anaesthesia in people with Postoperative Pain and Arm Injury, run by University of Pecs at 1 site in Hungary.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain, Arm Injury
- What is being tested?
- Upper extremity surgery under general anaesthesia and Upper extremity surgery under regional anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 5 Nov 2019to 10 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- upper extremity fracture
- surgery of hand/forearm or upper arm
- unpremedicated patients
- scheduled for elective or emergency trauma
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
University of Pécs, Medical School
Pécs, Baranya, 7632
Robert Almasi, PhD. habil, +36304294450, robert.almasi@pte.hu
Lajos Bogar, Prof. DSC, +3672535832 ext. 32420, bogar.lajos@pte.hu
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain, Arm Injury
- Being tested
- Upper extremity surgery under general anaesthesia, Upper extremity surgery under regional anaesthesia
- Medical subject headings
- Pain, Postoperative, Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper extremity surgery under general anaesthesiaProcedure or surgery
Forearm, wrist and hand surgery after fentanyl and propofol induction of anaesthesia, with sevoflurane maintenance
Upper extremity surgery under regional anaesthesiaProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Upper extremity surgery under general anaesthesia | Active comparator | Fentanyl 2 mcg/kg iv, propofol 2 mg/kg iv induction, 1MAC sevoflurane maintenance Receives: Procedure: Upper extremity surgery under general anaesthesia |
| Upper extremity surgery under regional anaesthesia | Active comparator | Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution Receives: Procedure: Upper extremity surgery under regional anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatostatin concentration in plasma
Plasma concentrations of somatostatin straight after and 6 hours after surgery.
Measured: 0-6 hours after surgery
Secondary outcomes (2)
Endocannabinoid concentrations in plasma
Plasma concentrations of endocannabinoids straight after and 6 hours after surgery.
Measured: 0-6 hours
Corticosteroid concentrations in plasma
Plasma concentrations of corticosteroids straight after and 6 hours after surgery.
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start5 Nov 2019
- Primary completion20 Nov 2021 (estimated)
- Study completion10 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert G Almasi, PhD.Habil., Study chair, University of Pecs, Medical School, Clinical Centre, Pain Medicine Dept.of Anesth Int CareZsofia Kriszta, MD., Principal investigator, University of Pecs, Medical School, Clinical Centre, Dept.of Anesth Int Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040738
- Sponsor's protocol ID
- 7726
- Acronym
- SECsGRUES
- Status last verified
- Nov 2021
- First submitted
- 5 Jun 2019
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Measurement of the Concentration of Blood Somatostatin and Fatty Amid Acids in Upper Extremity Trauma Surgery Under General and Regional Anesthesia
- ClinicalTrials.gov ID
- NCT04040738
- Acronym / sponsor ID
- SECsGRUES / 7726
- Conditions
- Postoperative Pain, Arm Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 20 Nov 2021 (estimated)
- Study completion
- 10 Jan 2022 (estimated)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Upper extremity surgery under general anaesthesia | Active comparator | Procedure: Upper extremity surgery under general anaesthesiaFentanyl 2 mcg/kg iv, propofol 2 mg/kg iv induction, 1MAC sevoflurane maintenance |
| Upper extremity surgery under regional anaesthesia | Active comparator | Procedure: Upper extremity surgery under regional anaesthesiaBupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- upper extremity fracture
- surgery of hand/forearm or upper arm
- unpremedicated patients
- scheduled for elective or emergency trauma
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper extremity surgery under general anaesthesiaForearm, wrist and hand surgery after fentanyl and propofol induction of anaesthesia, with sevoflurane maintenance | Procedure or surgery | Upper extremity surgery under general anaesthesia |
| Upper extremity surgery under regional anaesthesiaForearm, 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 | Procedure or surgery | Upper extremity surgery under regional anaesthesia |
Primary outcome
Somatostatin concentration in plasma
Time frame: 0-6 hours after surgery
Plasma concentrations of somatostatin straight after and 6 hours after surgery.
2 secondary outcomes
Endocannabinoid concentrations in plasma
Time frame: 0-6 hours
Corticosteroid concentrations in plasma
Time frame: 0-6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert G Almasi, PhD.Habil. study chair
University of Pecs, Medical School, Clinical Centre, Pain Medicine Dept.of Anesth Int Care
Zsofia Kriszta, MD. principal investigator
University of Pecs, Medical School, Clinical Centre, Dept.of Anesth Int Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper extremity surgery under general anaesthesia and Upper extremity surgery under regional anaesthesia in people with Postoperative Pain and Arm Injury, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert G Almasi, PhD.Habil. (+36304294450, almasi.robert@pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatostatin concentration in plasma (time frame: 0-6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.