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

Postoperative Pain Clinical Trial

— DBBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498923
• Other study ID #: LNMY-FPGE- ANESTHESIOLOGY-DBBA
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: April 5, 2022

Study information

• Verified date: April 2022
• Source: Lviv National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 5, 2022
• Est. primary completion date: April 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing upper or lower extremity orthopedic surgery

Exclusion Criteria:

• diabetes mellitus;

• diseases of the peripheral nerv system

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bupivacaine, dexamethasone, epinephrine
Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg

Locations

Country	Name	City	State
Ukraine	Rivne Oblast State Hospital	Rivne	Rivne Region

Sponsors (1)

Lead Sponsor	Collaborator
Lviv National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of 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.	6th, 12th, 24th and 36th hours after blockade
Secondary	The amount of narcotic anesthetic used in the postoperative period		48 hour after surgery

External Links

•   ORCID