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NCT Number: NCT04498923

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

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.

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Key information

Conditions

Postoperative Pain Agnosia Anesthesia Anesthesia, Local Fracture of the Lower Limb (Except Hip), Initial Encounter Fractures of the Upper Limb Intraoperative Hypertension Intraoperative Hypotension Local Anesthetic Systemic Toxicity Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pain Pain Syndrome Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Peripheral Neuropathy Postoperative Complications Signs and Symptoms Somatoform Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rivne Oblast State Hospital

Rivne, Rivne Oblast, 33000, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing upper or lower extremity orthopedic surgery

Exclusion criteria

  • diabetes mellitus;
  • diseases of the peripheral nerv system

Treatment and study plan

Bupivacaine, dexamethasone, epinephrine

Drug

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

Primary outcomes

  1. The duration of blockade

    Time frame: 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 outcomes

  1. The amount of narcotic anesthetic used in the postoperative period

    Time frame: 48 hour after surgery

Sponsors and collaborators

Lead sponsor

Lviv National Medical University

Other

Registry information

Official study title

Duration of Blockade of Peripheral Nerves With Low Concentrated Bupivacaine Solution Depending of the Adjuvants

Acronym: DBBA

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2020
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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