Postoperative PainDBBANCT04498923
Duration of Blockade of Peripheral Nerves With Bupivacaine Depending of the Adjuvants
An observational study of Postoperative Pain and Peripheral Neuropathy, run by Lviv National Medical University at 1 site in Ukraine.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Postoperative Pain, Peripheral Neuropathy, Fractures of the Upper Limb
- What is being tested?
- Bupivacaine, dexamethasone, epinephrine
- How many people
- 68 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Jan 2018to 5 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing orthopedic surgery on the upper and lower extremities in the Regional Center of Orthopedics, Traumatology and Vertebrology of Rivne Oblast State Hospital
Who may be able to join
- All patients undergoing upper or lower extremity orthopedic surgery
Who cannot join
- diabetes mellitus;
- diseases of the peripheral nerv system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration of Blockade of Peripheral Nerves With Low Concentrated Bupivacaine Solution 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.
Read the 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
- Being tested
- Bupivacaine, dexamethasone, epinephrine
- Keywords
- Regional anesthesia, Pain management, Local anesthetic, Electromyography
- Medical subject headings
- Pain, Postoperative, Peripheral Nervous System Diseases, Somatoform Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine, dexamethasone, epinephrineDrug
Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bupivacaine, dexamethasone, epinephrine | |
| 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. Receives: Drug: Bupivacaine, dexamethasone, epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6th, 12th, 24th and 36th hours after blockade
Secondary outcomes (1)
The amount of narcotic anesthetic used in the postoperative period
Measured: 48 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jan 2018
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lviv National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maksym Barsa, Lviv National Medical University
- Investigators
- Maksym Barsa, Principal investigator, Сlinical resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498923
- Sponsor's protocol ID
- LNMY-FPGE- ANESTHESIOLOGY-DBBA
- Acronym
- DBBA
- Status last verified
- Apr 2022
- First submitted
- 29 Jul 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Blockade of Peripheral Nerves With Low Concentrated Bupivacaine Solution Depending of the Adjuvants
- ClinicalTrials.gov ID
- NCT04498923
- Acronym / sponsor ID
- DBBA / LNMY-FPGE- ANESTHESIOLOGY-DBBA
- Conditions
- Postoperative Pain, Peripheral Neuropathy, Fractures of the Upper Limb, Fracture of the Lower Limb (Except Hip), Initial Encounter, Intraoperative Hypotension, Intraoperative Hypertension
- Keywords
- Regional anesthesia, Pain management, Local anesthetic, Electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Lviv National Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine with dexamethasone | – | Drug: Bupivacaine, dexamethasone, epinephrineUltrasound 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 | – | Drug: Bupivacaine, dexamethasone, epinephrineUltrasound 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing orthopedic surgery on the upper and lower extremities in the Regional Center of Orthopedics, Traumatology and Vertebrology of Rivne Oblast State Hospital
Key inclusion criteria (1 listed)
- All patients undergoing upper or lower extremity orthopedic surgery
Key exclusion criteria (2 listed)
- diabetes mellitus;
- diseases of the peripheral nerv system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine, dexamethasone, epinephrineBupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg | Drug | Bupivacaine with dexamethasone, Bupivacaine with dexamethasone and epinephrine |
Primary outcome
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.
1 secondary outcome
The amount of narcotic anesthetic used in the postoperative period
Time frame: 48 hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- ORCIDLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maksym Barsa principal investigator
Сlinical resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Peripheral Neuropathy, run by Lviv National Medical University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of blockade (time frame: 6th, 12th, 24th and 36th hours after blockade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022; AzTrials last refreshed its copy on 26 Oct 2026.