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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04498923
Acronym
DBBA
Enrollment
68
Registered
2020-08-05
Start date
2018-01-01
Completion date
2022-04-05
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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, Pain Syndrome, Peripheral Neuropathy, Postoperative Pain

Keywords

Regional anesthesia, Pain management, Local anesthetic, Electromyography

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.

Interventions

DRUGBupivacaine, dexamethasone, epinephrine

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

Sponsors

Lviv National Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients undergoing upper or lower extremity orthopedic surgery

Exclusion criteria

* diabetes mellitus; * diseases of the peripheral nerv system

Design outcomes

Primary

MeasureTime frameDescription
The duration of blockade6th, 12th, 24th and 36th hours after blockadeThe 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

MeasureTime frame
The amount of narcotic anesthetic used in the postoperative period48 hour after surgery

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026