Duration of Blockade of Peripheral Nerves With Bupivacaine Depending of the Adjuvants

NCT ID: NCT04498923

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-04-05

Brief Summary

The main aim of the investigator's study is to propose combination of local anesthetics and adjuvants that provides both adequate anesthesia during surgery and prolonged post-operative analgesia.

Detailed Description

Peripheral nerve plexuses blocks are performing as a component of analgesia in patients undergoing orthopedic surgery on the upper or lower extremities. Patients are divided into two groups depending on the adjuvant to the local anesthetic: 1st group - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02%; Group 2 - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02% and epinephrine 0.00018%. The duration of the blockade is estimated by puncturing the skin with a needle. The intensity of pain is assessed at 6, 12, 24 and 36 hours after blockade using Visual analog scale (VAS). The amount of narcotic anesthetic used in the postoperative period is also recorded. In addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery.

Conditions

Postoperative Pain; Peripheral Neuropathy; Fractures of the Upper Limb; Fracture of the Lower Limb (Except Hip), Initial Encounter; Intraoperative Hypotension; Intraoperative Hypertension; Pain Syndrome; Anesthesia; Anesthesia, Local; Local Anesthetic Systemic Toxicity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bupivacaine with dexamethasone

Ultrasound guided peripheral nerve block for upper or lower extremity was performed before orthopedic surgery using neurostimulator.

Twenty milliliters solution of bupivacaine 0,375% with dexamethasone was injected for one plexus or peripheral nerve.

Bupivacaine, dexamethasone, epinephrine

Intervention Type: DRUG

Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg

Bupivacaine with dexamethasone and epinephrine

Ultrasound guided peripheral nerve block for upper or lower extremity was performed before orthopedic surgery using neurostimulator.

Twenty milliliters solution of bupivacaine 0,375% with dexamethasone 0,02% and epinephrine 0,00018% was injected for one plexus or peripheral nerve.

Bupivacaine, dexamethasone, epinephrine

Intervention Type: DRUG

Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg

Interventions

Bupivacaine, dexamethasone, epinephrine

Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All patients undergoing upper or lower extremity orthopedic surgery

Exclusion Criteria

• diabetes mellitus;
• diseases of the peripheral nerv system

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lviv National Medical University

OTHER

Sponsor Role: lead

Responsible Party

Maksym Barsa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maksym Barsa

Role: PRINCIPAL_INVESTIGATOR

Сlinical resident

Locations

Rivne Oblast State Hospital

Rivne, Rivne Oblast, Ukraine

Countries

Ukraine

Related Links

https://orcid.org/0000-0002-2578-4935

ORCID

Other Identifiers

LNMY-FPGE- ANESTHESIOLOGY-DBBA

Identifier Type: -

Identifier Source: org_study_id