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

NCT04040738 | Unknown

• 1 other identifier: 7726
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Arm Injury

Outcome Measures

Primary Outcomes (1)

• Somatostatin concentration in plasma

  Plasma concentrations of somatostatin straight after and 6 hours after surgery.

  0-6 hours after surgery

Secondary Outcomes (2)

• Endocannabinoid concentrations in plasma

  0-6 hours

• Corticosteroid concentrations in plasma

  0-6 hours

Other Outcomes (1)

• Postoperative pain intensity: verbal numeric rate scale

  0-24 hours

Study Arms (2)

Upper extremity surgery under general anaesthesia

ACTIVE COMPARATOR

Fentanyl 2 mcg/kg iv, propofol 2 mg/kg iv induction, 1MAC sevoflurane maintenance

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

Procedure: Upper extremity surgery under regional anaesthesia

Interventions

Upper extremity surgery under general anaesthesia PROCEDURE

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

Upper extremity surgery under general anaesthesia

Upper extremity surgery under regional anaesthesia PROCEDURE

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

Upper extremity surgery under regional anaesthesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• upper extremity fracture
• surgery of hand/forearm or upper arm
• unpremedicated patients
• scheduled for elective or emergency trauma

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

University of Pécs, Medical School

Pécs, Baranya, 7632, Hungary

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Arm Injuries

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Wounds and Injuries

Study Officials

• Robert G Almasi, PhD.Habil.

  University of Pecs, Medical School, Clinical Centre, Pain Medicine Dept.of Anesth Int Care

  STUDY CHAIR

• Zsofia Kriszta, MD.

  University of Pecs, Medical School, Clinical Centre, Dept.of Anesth Int Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert G Almasi, PhD.Habil.

CONTACT

+36304294450; almasi.robert@pte.hu

Erika Pintér, DSC., Prof

CONTACT

+36204338395; erika.pinter@aok.pte.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The labour analyst, the investigator, the statistician is unaware of group allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: August 1, 2019
• Study Start: November 5, 2019
• Primary Completion: November 20, 2021
• Study Completion: January 10, 2022
• Last Updated: November 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)