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

Completed

• Conditions: Pain Syndrome; Peripheral Neuropathy; Fracture of the Lower Limb (Except Hip), Initial Encounter; Intraoperative Hypotension; Intraoperative Hypertension; Anesthesia, Local; Local Anesthetic Systemic Toxicity; Postoperative Pain; Fractures of the Upper Limb; Anesthesia
• Interventions: Drug: Bupivacaine, dexamethasone, epinephrine

• Registration Number: NCT04498923
• Lead Sponsor: Lviv National Medical University

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-08-02
• Study First Posted: 2020-08-05
• Status Verified: 2022-04
• Primary Completion: 2022-04-05
• Study Completion: 2022-04-05
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• All patients undergoing upper or lower extremity orthopedic surgery

Exclusion Criteria

• diabetes mellitus;
• diseases of the peripheral nerv system

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bupivacaine with dexamethasone	Bupivacaine, dexamethasone, 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 was injected for one plexus or peripheral nerve.
Bupivacaine with dexamethasone and epinephrine	Bupivacaine, dexamethasone, 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.

Primary Outcome Measures

Name	Time	Method
The duration of blockade	6th, 12th, 24th and 36th hours after blockade	The duration of the blockade was estimated by puncturing the skin with a needle every hour. In addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
The amount of narcotic anesthetic used in the postoperative period	48 hour after surgery

Trial Locations

Locations (1)

Rivne Oblast State Hospital; 🇺🇦 Rivne, Rivne Region, Ukraine