PremixedNCT06570096
Premixed vs Sequential Injections of Lidocaine and Bupivacaine for Supraclavicular Brachial Plexus Block in Patients Undergoing Arteriovenous Fistula Creation
A study testing Lidocaine 2% then bupivacaine 0.5% and Lidocaine 2% and bupivacaine 0.5% in people with Premixed and Sequential, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare premixed and sequential injections of lidocaine and bupivacaine for supraclavicular brachial plexus block in patients undergoing arteriovenous fistula creation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Premixed, Sequential, Lidocaine
- What is being tested?
- Lidocaine 2% then bupivacaine 0.5% and Lidocaine 2% and bupivacaine 0.5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Aug 2024to 16 Mar 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status III.
- Undergoing arteriovenous Fistula creation.
Who cannot join
- Allergy to local anesthetics.
- Body mass index (BMI) ≥ 35 kg/m2.
- Preoperative neurological deficit.
- Neuromuscular disorder.
- Psychiatric disorder.
- Coagulation disorder.
Show all 9Show fewer
- Congestive heart failure.
- Pregnancy.
- Infection at the site of block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Premixed Versus Sequential Injections of Lidocaine and Bupivacaine for Supraclavicular Brachial Plexus Block in Patients Undergoing Arteriovenous Fistula Creation: A Randomized Clinical Trial
This study aims to compare premixed and sequential injections of lidocaine and bupivacaine for supraclavicular brachial plexus block in patients undergoing arteriovenous fistula creation.
Read the detailed description
Hemodialysis is the common treatment for end-stage renal disease (ESRD) condition which improves quality of life and survival rate for this group of patients. Arteriovenous fistula (AVF) creation is the vascular access technique that provides long-term vascular access for hemodialysis patients.
Ultrasound-guided supraclavicular brachial plexus block (SCBPB) is a widely accepted and effective technique for AVF creation procedures. It provides analgesia, sympathetic blockade, optimal surgical conditions, and adequate duration of postoperative block that prevents arterial spasm and graft thrombosis. It offers higher blood flow in the radial artery and arteriovenous fistula than is achieved with infiltration anesthesia.
Lipid-soluble local anesthetics (LA) such as ropivacaine and bupivacaine are generally more potent and have a significantly longer duration of action as well as a more prolonged onset of action compared to intermediate-potency drugs such as lignocaine, mepivacaine, and prilocaine. A combination of two LAs is often used in regional blocks to utilize the different clinical properties of the drugs to achieve a faster onset and longer block duration.
- Conditions
- Premixed, Sequential, Lidocaine, Bupivacaine, Supraclavicular Brachial Plexus Block, Arteriovenous Fistula
- Being tested
- Lidocaine 2% then bupivacaine 0.5%, Lidocaine 2% and bupivacaine 0.5%
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% then bupivacaine 0.5%Drug
Patients will receive 10 ml of lidocaine 2% then 10 ml of bupivacaine 0.5% with a delay of 120s between injections.
Lidocaine 2% and bupivacaine 0.5%Drug
Patients will receive 20 ml of freshly prepared mixtures of 10 ml of lidocaine 2% and 10 ml of bupivacaine 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| Sequential Injections group | Experimental | Patients will receive 10 ml of lidocaine 2% then 10 ml of bupivacaine 0.5% with a delay of 120s between injections. Receives: Drug: Lidocaine 2% then bupivacaine 0.5% |
| Premixed Injections group | Active comparator | Patients will receive 20 ml of freshly prepared mixtures of 10 ml of lidocaine 2% and 10 ml of bupivacaine 0.5% Receives: Drug: Lidocaine 2% and bupivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with a complete four-nerve sensory block
Percentage of participants with a complete four-nerve sensory block at 10 minutes will be recorded.
Measured: With in 10 minutes intraoperatively
Secondary outcomes (6)
Time of onset of sensory block
Time of onset of sensory block is defined as time interval between end of local anesthetics injection and complete loss of sensation to pin prick in all four nerve distribution areas, and the duration of sensory block is defined as the time interval between onset of sensory block and reappearance of pinprick sensation in all four nerve distribution areas.
Measured: Intraoperatively
Time of onset of motor block
Time of onset of motor block is defined as the time interval between the completion of local anesthetics injection and the inability of patient to move the elbow, wrist and fingers of the operating limb.
Measured: Intraoperatively
Degree of pain
Degree of pain will be recorded using numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). It will be assessed every 2 hours for 6 hours then every 4 hours for 24 hours postoperatively.
Measured: 24 hours postoperatively
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated) will be recorded.
Measured: 24 hours postoperatively
Degree of patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as local anesthetics systemic toxicity, PONV, hypotension, pneumothorax, or any other complication will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start24 Aug 2024
- Primary completion16 Mar 2025
- Study completion16 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PremixedStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570096
- Sponsor's protocol ID
- 36264PR746/7/2024
- Status last verified
- Apr 2025
- First submitted
- 22 Aug 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premixed Versus Sequential Injections of Lidocaine and Bupivacaine for Supraclavicular Brachial Plexus Block in Patients Undergoing Arteriovenous Fistula Creation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06570096
- Acronym / sponsor ID
- 36264PR746/7/2024
- Conditions
- Premixed, Sequential, Lidocaine, Bupivacaine, Supraclavicular Brachial Plexus Block, Arteriovenous Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 16 Mar 2025 (actual)
- First posted
- 26 Aug 2024 (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.
This study aims to compare premixed and sequential injections of lidocaine and bupivacaine for supraclavicular brachial plexus block in patients undergoing arteriovenous fistula creation.
Detailed description
Hemodialysis is the common treatment for end-stage renal disease (ESRD) condition which improves quality of life and survival rate for this group of patients. Arteriovenous fistula (AVF) creation is the vascular access technique that provides long-term vascular access for hemodialysis patients.
Ultrasound-guided supraclavicular brachial plexus block (SCBPB) is a widely accepted and effective technique for AVF creation procedures. It provides analgesia, sympathetic blockade, optimal surgical conditions, and adequate duration of postoperative block that prevents arterial spasm and graft thrombosis. It offers higher blood flow in the radial artery and arteriovenous fistula than is achieved with infiltration anesthesia.
Lipid-soluble local anesthetics (LA) such as ropivacaine and bupivacaine are generally more potent and have a significantly longer duration of action as well as a more prolonged onset of action compared to intermediate-potency drugs such as lignocaine, mepivacaine, and prilocaine. A combination of two LAs is often used in regional blocks to utilize the different clinical properties of the drugs to achieve a faster onset and longer block duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential Injections group | Experimental | Drug: Lidocaine 2% then bupivacaine 0.5%Patients will receive 10 ml of lidocaine 2% then 10 ml of bupivacaine 0.5% with a delay of 120s between injections. |
| Premixed Injections group | Active comparator | Drug: Lidocaine 2% and bupivacaine 0.5%Patients will receive 20 ml of freshly prepared mixtures of 10 ml of lidocaine 2% and 10 ml of bupivacaine 0.5% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status III.
- Undergoing arteriovenous Fistula creation.
Key exclusion criteria (9 listed)
- Allergy to local anesthetics.
- Body mass index (BMI) ≥ 35 kg/m2.
- Preoperative neurological deficit.
- Neuromuscular disorder.
- Psychiatric disorder.
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 |
|---|---|---|
| Lidocaine 2% then bupivacaine 0.5%Patients will receive 10 ml of lidocaine 2% then 10 ml of bupivacaine 0.5% with a delay of 120s between injections. | Drug | Sequential Injections group |
| Lidocaine 2% and bupivacaine 0.5%Patients will receive 20 ml of freshly prepared mixtures of 10 ml of lidocaine 2% and 10 ml of bupivacaine 0.5%. | Drug | Premixed Injections group |
Primary outcome
Percentage of participants with a complete four-nerve sensory block
Time frame: With in 10 minutes intraoperatively
Percentage of participants with a complete four-nerve sensory block at 10 minutes will be recorded.
6 secondary outcomes
Time of onset of sensory block
Time frame: Intraoperatively
Time of onset of motor block
Time frame: Intraoperatively
Degree of pain
Time frame: 24 hours postoperatively
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
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 8 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Premixed
Active, not recruitingPhase 3
Clinical and Radiographic Evaluation of Three Biomimetic Materials in Pulp Therapy of Immature Young Permanent Teeth "A Randomized Controlled Clinical Trial"
Pulpotomy of Young Permanent Molars
Active, not recruitingObservational study
Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) in Pulpotomies Primary Teeth
Pulpotomies on Primary Molars
Enrolling by invitationPhase 4
A Study Comparing Degu Insulin Liraglutide Injection With Premixed Insulin on the Prognosis of Diabetes Mellitus
Type 2 Diabetic Patients
Recruiting
Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication Versus Formocresol
Vital, Pulpotomy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 2% then bupivacaine 0.5% and Lidocaine 2% and bupivacaine 0.5% in people with Premixed and Sequential, run by Tanta University at 1 site in Egypt.
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 4 inclusion and 9 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 8 Apr 2025. 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 Egypt. 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?
Percentage of participants with a complete four-nerve sensory block (time frame: With in 10 minutes intraoperatively). 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 8 Apr 2025.