Bier BlockPhase 4NCT06696586
Comparison Between Effect of Systemic Fentanyl Infusion and Fentanyl Added as An Adjuvant to Lidocaine in Bier Block For Controlling Pain in Patients Undergoing Hand Surgeries
A Phase 4 study testing Fentanyl infusion and Fentanyl Injection in people with Bier Block and Hand Surgery, run by Assiut University.
Trial summary
Injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain. Various techniques of regional anesthesia are frequently used for upper extremity surgery. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Bier Block, Hand Surgery
- What is being tested?
- Fentanyl infusion and Fentanyl Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age from 18 years to 40 years
- Both sex
- Patients of the American Society of Anesthesiologists (ASA) physical Status class I and II
- BMI less than 40
Who cannot join
- • Patients who refuse to participate in study.
- Uncooperative patients.
- Patient with crush injury
- Peripheral vascular, neurological or muscle diseases.
- Coagulation disorders that affect the blood's clotting activities e.g.: Hemophilia.
- History of hypersensitivity to the drugs being evaluated
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Abdelrahman Mostafa Ibrahim Hashim, resident doctor contact
About this study
Injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain.
Various techniques of regional anesthesia are frequently used for upper extremity surgery. Specifically, intravenous regional anesthesia, the Bier block, is an effective anesthetic technique. This technique, developed by Dr August Bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. However, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. Because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome the aim of this study To evaluate the effect of Systemic Fentanyl Infusion compared to addition of Fentanyl as An Adjuvant to Lidocaine in Bier Block for Controlling Pain in Patients Undergoing Hand Surgeries
Read the detailed description
Injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain.
Various techniques of regional anesthesia are frequently used for upper extremity surgery. Specifically, intravenous regional anesthesia, the Bier block, is an effective anesthetic technique. This technique, developed by Dr August Bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. However, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. Because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome
- Conditions
- Bier Block, Hand Surgery
- Being tested
- Fentanyl infusion, Fentanyl Injection
- Keywords
- Systemic Fentanyl Infusion, Fentanyl Added as An Adjuvant to Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl infusionDrug
will received lidocaine with dose 250 mg and fentanyl infusion in dose of 200 µg in rate 10ml /hr using 50ml syringe pump.
Fentanyl InjectionDrug
will receive lidocaine 250 mg in addition to fentanyl injection in dose 100 µg by shots
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | patients will received lidocaine with dose 250 mg and fentanyl infusion in dose of 200 µg in rate 10ml /hr using 50ml syringe pump Receives: Drug: Fentanyl infusion |
| group 2 | Experimental | patients will receive lidocaine 250 mg in addition to fentanyl injection in dose 100 µg by shots Receives: Drug: Fentanyl Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare intraoperative pain between systemic and local fentanyl using VAS score
pain will be assessed using an 11-point (0=no pain and 10=worst pain) VAS scale
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bier BlockStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mostafa Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696586
- Sponsor's protocol ID
- Fentanyl Bier Block
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jung H, Lee KH, Jeong Y, Lee KH, Yoon S, Kim WH, Lee HJ. Effect of Fentanyl-Based Intravenous Patient-Controlled Analgesia with and without Basal Infusion on Postoperative Opioid Consumption and Opioid-Related Side Effects: A Retrospective Cohort Study. J Pain Res. 2020 Nov 24;13:3095-3106. doi: 10.2147/JPR.S281041. eCollection 2020.
PubMed 33262644Glick JL, Christensen T, Park JN, McKenzie M, Green TC, Sherman SG. Stakeholder perspectives on implementing fentanyl drug checking: Results from a multi-site study. Drug Alcohol Depend. 2019 Jan 1;194:527-532. doi: 10.1016/j.drugalcdep.2018.10.017. Epub 2018 Nov 13.
PubMed 30551090Farzam R, Deilami M, Jalili S, Kamali K. Comparison of Anesthesia Results between Wide Awake Local Anesthesia no Tourniquet (WALANT) and Forearm Tourniquet Bier Block in Hand Surgeries: A Randomized Clinical Trial. Arch Bone Jt Surg. 2021 Jan;9(1):116-121. doi: 10.22038/abjs.2020.49526.2487.
PubMed 33778124Badeaux J, Bonanno L, Au H. Effectiveness of ondansetron as an adjunct to lidocaine intravenous regional anesthesia on tourniquet pain and postoperative pain in patients undergoing elective hand surgery: a systematic review protocol. JBI Database System Rev Implement Rep. 2015 Jan;13(1):27-38. doi: 10.11124/jbisrir-2015-1768.
PubMed 26447005
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Effect of Systemic Fentanyl Infusion and Fentanyl Added as An Adjuvant to Lidocaine in Bier Block For Controlling Pain in Patients Undergoing Hand Surgeries
- ClinicalTrials.gov ID
- NCT06696586
- Acronym / sponsor ID
- Fentanyl Bier Block
- Conditions
- Bier Block, Hand Surgery
- Keywords
- Systemic Fentanyl Infusion, Fentanyl Added as An Adjuvant to Lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Nov 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.
Injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain.
Various techniques of regional anesthesia are frequently used for upper extremity surgery. Specifically, intravenous regional anesthesia, the Bier block, is an effective anesthetic technique. This technique, developed by Dr August Bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. However, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. Because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome the aim of this study To evaluate the effect of Systemic Fentanyl Infusion compared to addition of Fentanyl as An Adjuvant to Lidocaine in Bier Block for Controlling Pain in Patients Undergoing Hand Surgeries
Detailed description
Injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain.
Various techniques of regional anesthesia are frequently used for upper extremity surgery. Specifically, intravenous regional anesthesia, the Bier block, is an effective anesthetic technique. This technique, developed by Dr August Bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. However, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. Because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Fentanyl infusionpatients will received lidocaine with dose 250 mg and fentanyl infusion in dose of 200 µg in rate 10ml /hr using 50ml syringe pump |
| group 2 | Experimental | Drug: Fentanyl Injectionpatients will receive lidocaine 250 mg in addition to fentanyl injection in dose 100 µg by shots |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients age from 18 years to 40 years
Key exclusion criteria (6 listed)
- • Patients who refuse to participate in study.
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 |
|---|---|---|
| Fentanyl infusionwill received lidocaine with dose 250 mg and fentanyl infusion in dose of 200 µg in rate 10ml /hr using 50ml syringe pump. | Drug | group 1 |
| Fentanyl Injectionwill receive lidocaine 250 mg in addition to fentanyl injection in dose 100 µg by shots | Drug | group 2 |
Primary outcome
to compare intraoperative pain between systemic and local fentanyl using VAS score
Time frame: baseline
pain will be assessed using an 11-point (0=no pain and 10=worst pain) VAS scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Results publication: PubMed 33262644Jung H, Lee KH, Jeong Y, Lee KH, Yoon S, Kim WH, Lee HJ. Effect of Fentanyl-Based Intravenous Patient-Controlled Analgesia with and without Basal Infusion on Postoperative Opioid Consumption and Opioid-Related Side Effects: A Retrospective Cohort Study. J Pain Res. 2020 Nov 24;13:3095-3106. doi: 10.2147/JPR.S281041. eCollection 2020.
- Results publication: PubMed 30551090Glick JL, Christensen T, Park JN, McKenzie M, Green TC, Sherman SG. Stakeholder perspectives on implementing fentanyl drug checking: Results from a multi-site study. Drug Alcohol Depend. 2019 Jan 1;194:527-532. doi: 10.1016/j.drugalcdep.2018.10.017. Epub 2018 Nov 13.
- Results publication: PubMed 33778124Farzam R, Deilami M, Jalili S, Kamali K. Comparison of Anesthesia Results between Wide Awake Local Anesthesia no Tourniquet (WALANT) and Forearm Tourniquet Bier Block in Hand Surgeries: A Randomized Clinical Trial. Arch Bone Jt Surg. 2021 Jan;9(1):116-121. doi: 10.22038/abjs.2020.49526.2487.
- Results publication: PubMed 26447005Badeaux J, Bonanno L, Au H. Effectiveness of ondansetron as an adjunct to lidocaine intravenous regional anesthesia on tourniquet pain and postoperative pain in patients undergoing elective hand surgery: a systematic review protocol. JBI Database System Rev Implement Rep. 2015 Jan;13(1):27-38. doi: 10.11124/jbisrir-2015-1768.
- Individual participant dataSharing planned: Undecided
Related trials for Bier Block
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Lidocaine vs. Lidocaine With Dexmedetomidine for Intravenous Regional Anesthesia (IVRA) in Upper Limb Surgery
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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.
Abdelrahman Mostafa Ibrahim Hashim, resident doctor contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl infusion and Fentanyl Injection in people with Bier Block and Hand Surgery, run by Assiut University.
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 6 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: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Mostafa Ibrahim Hashim, resident doctor (+201094082185, abdeIrahman.16266096@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare intraoperative pain between systemic and local fentanyl using VAS score (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06696586, which also lists 4 linked publications.
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 18 Apr 2025.