Bier BlockNCT05342870
A Sequential Allocation Study to Determine the ED50 of Dexmetedomidine as an Adjuvant to Lidocaine Intravenous Regional Anesthesia
A study testing Dexmedetomidine in people with Bier Block and Dexmedetomidine, run by American University of Beirut Medical Center.
Trial summary
Intravenous Regional Anesthesia (IVRA) is an easy and reliable anesthetic technique for hand and forearm surgery. Its use is however limited by the presence of tourniquet pain during the surgery and the absence of postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bier Block, Dexmedetomidine, Tourniquet Pain
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Aug 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 to 70 years of age, ASA physical status I-II, undergoing unilateral hand or forearm surgery (that require 30 minutes or more) under IVRA.
Who cannot join
- •Patients with Raynaud's disease, sickle cell anemia, heart block, allergy to any of the anesthetic drugs used, patients on α-adrenergic agonists, ASA III or IV, emergency surgery and pregnant patients., Weight greater than 100Kg.
About this study
Intravenous Regional Anesthesia (IVRA) is an easy and reliable anesthetic technique for hand and forearm surgery. Its use is however limited by the presence of tourniquet pain during the surgery and the absence of postoperative analgesia. Many adjuvants to local anesthetics have been studied in order to overcome these shortcomings, including α2 adrenergic agonists. Clonidine has been shown to be efficacious when used with IVRA at a dose of 1µg/kg. Dexmetedomidine (DEX) is a recent more selective α2 adrenergic agonist that has been used successfully during IVRA at a dose of 0.5µg/kg. However when comparing potency ratios of Clonidine and DEX (8 to 1), the investigators hypothesize that a lower DEX dose would provide patients with adequate anesthesia.
We will determine the population average dose of DEX (ED50) that provides 50 minutes of tolerance to the tourniquet during a Lidocaine IVRA by a sequential Dixon up-down allocation study.
Read more
Eligible patients will be enrolled after obtaining informed consent. Patients will receive a standardized IVRA with Lidocaine and DEX adjuvant following a sequential allocation scheme. The first patient will receive a dose of 0.5 µg/kg of DEX. The dose will be then adjusted in 0.1 µg/kg increments for the following patients dependent on the success of the previous patients block. If a patient experiences tourniquet pain prior to 50 minutes after inflation of the distal tourniquet the next patient will receive a higher dose, if he does not experience pain prior to 50 minutes after inflation of the distal tourniquet the dose for the following patient will be decreased.
Recruitment will continue until 6 independent crossovers are observed with a minimum of 20 patients. The mean and the standard deviation of the ED50 of DEX will be calculated using the modified up-down method.
This study will help determine the ED50 of DEX used as an adjuvant in IVRA. Based on the potency ratios of Clonidine vs. DEX, the investigators hypothesize that the dose of DEX needed to achieve 50 minutes of pain free tourniquet time will be closer to 0.125 µg/kg rather than 0.5 µg/kg, a 75% reduction in the dose studied.
- Conditions
- Bier Block, Dexmedetomidine, Tourniquet Pain, Carpal Tunnel, Tendon Release, Tendn Transfer
- Being tested
- Dexmedetomidine
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Following a sequential allocation scheme, the dexmedetomidine dose for each patient was determined by the Dixon up-and-down method. The dexmedetomidine dose for the first patient was 0.5 µg/kg. The dose was then adjusted in 0.1 µg/kg increments for the following patients depending on the success of the previous patient's block. If a patient experienced tourniquet pain prior to T0 + 50 minutes the next patient received a higher dose. If a patient did not experience pain at T0 + 50 minutes of tourniquet time the dose for the following patient was decreased. Identical syringes containing the solution mix were prepared by the principal investigator and handed to the blinded anesthesiologist in the room. Stopping rules were set at 6 independent crossovers in the same direction (no pain to pain or pain to no pain), with a minimum number of 20 patients
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median effective dose of dexmedetomidine
The dexmedetomidine dose for the first patient was 0.5 µg/kg, the minimum tourniquet time chosen for our study was 50 minutes. The dose was then adjusted in 0.1 µg/kg increments for the following patients depending on the success of the previous patient's block. If a patient experienced tourniquet pain prior to T0 + 50 minutes the next patient received a higher dose. If a patient did not experience pain at T0 + 50 minutes of tourniquet time the dose for the following patient was decreased. Stopping rules were set at 6 independent crossovers in the same direction (no pain to pain or pain to no pain), with a minimum number of 20 patients. The mean and standard deviation of the ED50 of dexmedetomidine were calculated using the modified up-and-down method, which uses the average dexmedetomidine dose of all independent pairs of patients involved a crossover to calculate the ED50
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bier BlockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carine Zeeni, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342870
- Sponsor's protocol ID
- ANES.CZ.01
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are not publicly available because the publicity policy is not yet generated by our institutional review board but are available from the corresponding author on reasonable request.
Publications
Karam C, Al Assadi S, Kanazi G, Zeeni C. A sequential allocation study to determine the ED50 of Dexmedetomidine as an adjuvant to lidocaine intravenous regional anesthesia. BMC Anesthesiol. 2022 May 27;22(1):165. doi: 10.1186/s12871-022-01702-9.
PubMed 35624418
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential Allocation Study to Determine the ED50 of Dexmetedomidine as an Adjuvant to Lidocaine Intravenous Regional Anesthesia
- ClinicalTrials.gov ID
- NCT05342870
- Acronym / sponsor ID
- ANES.CZ.01
- Conditions
- Bier Block, Dexmedetomidine, Tourniquet Pain, Carpal Tunnel, Tendon Release, Tendn Transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Apr 2022 (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.
Intravenous Regional Anesthesia (IVRA) is an easy and reliable anesthetic technique for hand and forearm surgery. Its use is however limited by the presence of tourniquet pain during the surgery and the absence of postoperative analgesia. Many adjuvants to local anesthetics have been studied in order to overcome these shortcomings, including α2 adrenergic agonists. Clonidine has been shown to be efficacious when used with IVRA at a dose of 1µg/kg. Dexmetedomidine (DEX) is a recent more selective α2 adrenergic agonist that has been used successfully during IVRA at a dose of 0.5µg/kg. However when comparing potency ratios of Clonidine and DEX (8 to 1), the investigators hypothesize that a lower DEX dose would provide patients with adequate anesthesia.
We will determine the population average dose of DEX (ED50) that provides 50 minutes of tolerance to the tourniquet during a Lidocaine IVRA by a sequential Dixon up-down allocation study.
Eligible patients will be enrolled after obtaining informed consent. Patients will receive a standardized IVRA with Lidocaine and DEX adjuvant following a sequential allocation scheme. The first patient will receive a dose of 0.5 µg/kg of DEX. The dose will be then adjusted in 0.1 µg/kg increments for the following patients dependent on the success of the previous patients block. If a patient experiences tourniquet pain prior to 50 minutes after inflation of the distal tourniquet the next patient will receive a higher dose, if he does not experience pain prior to 50 minutes after inflation of the distal tourniquet the dose for the following patient will be decreased.
Recruitment will continue until 6 independent crossovers are observed with a minimum of 20 patients. The mean and the standard deviation of the ED50 of DEX will be calculated using the modified up-down method.
This study will help determine the ED50 of DEX used as an adjuvant in IVRA. Based on the potency ratios of Clonidine vs. DEX, the investigators hypothesize that the dose of DEX needed to achieve 50 minutes of pain free tourniquet time will be closer to 0.125 µg/kg rather than 0.5 µg/kg, a 75% reduction in the dose studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 to 70 years of age, ASA physical status I-II, undergoing unilateral hand or forearm surgery (that require 30 minutes or more) under IVRA.
Key exclusion criteria (1 listed)
- •Patients with Raynaud's disease, sickle cell anemia, heart block, allergy to any of the anesthetic drugs used, patients on α-adrenergic agonists, ASA III or IV, emergency surgery and pregnant patients., Weight greater than 100Kg.
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 |
|---|---|---|
| DexmedetomidineFollowing a sequential allocation scheme, the dexmedetomidine dose for each patient was determined by the Dixon up-and-down method. The dexmedetomidine dose for the first patient was 0.5 µg/kg. The dose was then adjusted in 0.1 µg/kg increments for the following patients depending on the success of the previous patient's block. If a patient experienced tourniquet pain prior to T0 + 50 minutes the next patient received a higher dose. If a patient did not experience pain at T0 + 50 minutes of tourniquet time the dose for the following patient was decreased. Identical syringes containing the solution mix were prepared by the principal investigator and handed to the blinded anesthesiologist in the room. Stopping rules were set at 6 independent crossovers in the same direction (no pain to pain or pain to no pain), with a minimum number of 20 patients | Drug | Dexmedetomidine |
Primary outcome
Median effective dose of dexmedetomidine
Time frame: During the procedure
The dexmedetomidine dose for the first patient was 0.5 µg/kg, the minimum tourniquet time chosen for our study was 50 minutes. The dose was then adjusted in 0.1 µg/kg increments for the following patients depending on the success of the previous patient's block. If a patient experienced tourniquet pain prior to T0 + 50 minutes the next patient received a higher dose. If a patient did not experience pain at T0 + 50 minutes of tourniquet time the dose for the following patient was decreased. Stopping rules were set at 6 independent crossovers in the same direction (no pain to pain or pain to no pain), with a minimum number of 20 patients. The mean and standard deviation of the ED50 of dexmedetomidine were calculated using the modified up-and-down method, which uses the average dexmedetomidine dose of all independent pairs of patients involved a crossover to calculate the ED50
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 25 Apr 2022.
- Derived from this study: PubMed 35624418Karam C, Al Assadi S, Kanazi G, Zeeni C. A sequential allocation study to determine the ED50 of Dexmedetomidine as an adjuvant to lidocaine intravenous regional anesthesia. BMC Anesthesiol. 2022 May 27;22(1):165. doi: 10.1186/s12871-022-01702-9.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are not publicly available because the publicity policy is not yet generated by our institutional review board but are available from the corresponding author on reasonable request.
Related trials for Bier Block
Not yet recruitingPhase 4
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
Bier Block, Hand Surgery
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.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Bier Block and Dexmedetomidine, run by American University of Beirut Medical Center.
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 1 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 25 Apr 2022. 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.
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?
Median effective dose of dexmedetomidine (time frame: During the procedure). 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 NCT05342870, which also lists 1 linked publication.
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 25 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.