Intravenous Anesthetic Agent OverdoseNCT06448845
A Comparative Study Between Arm Intravenous Regional Anesthesia Versus Forearm Intravenous Regional Anesthesia in Patients Undergoing Hand and Wrist Surgery
A study testing Arm intravenous regional anesthesia and Forearm IVRA block in people with Intravenous Anesthetic Agent Overdose and Hand Injury Wrist, run by Ain Shams University at 1 site in Egypt.
Trial summary
The technique of intravenous regional analgesia using a tourniquet consisting of two cuffs over the upper arm is a well-known procedure, With the tourniquet being conventionally placed over the upper arm, a relatively high dose of local anaesthetic drug is required and occasionally systemic toxic reactions have… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Intravenous Anesthetic Agent Overdose, Hand Injury Wrist
- What is being tested?
- Arm intravenous regional anesthesia and Forearm IVRA block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of American Society of Anesthesiologists (ASA) physical status I to II.
- Both sexes.
- ≥ 21 to 65 years.
- scheduled for elective hand and wrist surgeries.
Who cannot join
- American society of Anesthesiologists (ASA) physical status ≥3 or BMI ≥40
- Patients will do bilateral hand surgery
- Local site infection.
- Allergy to local anesthetics.
- Patient refusal
- Patients with pre-existing myopathy or neuropathy on the operating limb.
- Patients with significant cognitive dysfunction.
- Chronic analgesic abuser patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Arm Intravenous Regional Anesthesia Versus Forearm Intravenous Regional Anesthesia in Patients Undergoing Hand and Wrist Surgery. A Randomized Comparative Prospective Clinical Study
The technique of intravenous regional analgesia using a tourniquet consisting of two cuffs over the upper arm is a well-known procedure, With the tourniquet being conventionally placed over the upper arm, a relatively high dose of local anaesthetic drug is required and occasionally systemic toxic reactions have occurred.
The purpose of the present study is to establish the efficacy of the technique of intravenous regional analgesia with a forearm tourniquet using reduced doses of lidocaine.
Read the detailed description
Several ways of anesthesia can be used to perform hand surgery, being general anesthesia, intravenous regional anesthesia as well as locoregional anesthesia. Locoregional anesthesia and intravenous regional anesthesia are often performed since patients can be discharged from the hospital more rapidly. A conventional Biers block is performed using a tourniquet on the upper arm to create a bloodless field and to contain the anesthetics within the surgical area.
A mini-Biers block in which the tourniquet is placed on the forearm, has been shown to be a safe and effective way of anesthesia to perform hand and wrist surgery. By using this type of anesthesia, the dose of the anesthetic can be reduced compared to a conventional Bier's block which reduces the risk of systemic toxicity reactions.
Intravenous regional anesthesia (IVRA) or Bier's Block is a simple and effective but underused anesthetic technique for hand and wrist surgery, This technique, introduced by Dr.August Bier in1908, provides complete anesthesia as well as a bloodless field during surgery.
Traditionally, an upper arm tourniquet has been used to sequester the local anesthetic and to create a bloodless Surgical field. Major complications after IVRA with an upper arm tourniquet are rare but are mostly related to local anesthetic systemic toxicity after release of the tourniquet.
Use of a forearm tourniquet has been introduced in 1978 and comes with the big advantage of lower (non-toxic) local anesthetic dosage requirement to produce a good quality of analgesia.
Consequently, there is no minimal tourniquet inflation time after forearm IVRA. In addition ,it has been postulated that sensory onset time after forearm IVRA may be shorter than after upper arm IVRA. With these two features forearm IVRA may be the ideal anesthetic technique for short surgery of hand and wrist.
- Being tested
- Arm intravenous regional anesthesia, Forearm IVRA block
- Keywords
- Forearm Tourniquet, Intravenous Regional Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm intravenous regional anesthesiaProcedure or surgery
Also called Bier's Block
After placement of the upper arm and forearm tourniquets and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the arm tourniquet cuff is inflated to a pressure of 250 mmHg. The double arm cuff pneumatic pressure tourniquet is placed immediately above the elbow crease and on the top of a circumferentially placed cotton cast padding before inflation. Subsequently, tourniquet failure is ruled out by observing the absence of distal circulation and 40 ml 0.5% lidocaine is slowly injected through the intravenous cannula on the dorsum of the hand. The tourniquet remained inflated for 60 minutes from injection of lidocaine to reduce the risk of local anesthetic systemic toxicity (LAST)
Forearm IVRA blockProcedure or surgery
Also called Mini Bier's Block
After placement of the forearm double tourniquet and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the forearm tourniquet cuff is inflated to a pressure of 250 mmHg. The forearm tourniquet will be placed 5 cm distal to the medial epicondyle of the humerus and on the top of a circumferentially placed cotton cast. Subsequently, tourniquet failure is ruled out by observing the distal circulation and 25 ml 0.5% lidocaine is slowly injected through the intravenous cannula on the dorsum of the hand.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Arm IVRA) 70 patients | Active comparator | After placement of the upper arm and forearm tourniquets and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the arm tourniquet cuff is inflated to a pressure of 250 mmHg. The double arm cuff pneumatic pressure tourniquet is placed immediately above the elbow crease and on the top of a circumferentially placed cotton cast padding before inflation. Receives: Procedure: Arm intravenous regional anesthesia |
| Group F (Forearm IVRA) 70 patients | Active comparator | After placement of the forearm double tourniquet and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the forearm tourniquet cuff is inflated to a pressure of 250 mmHg. The forearm tourniquet will be placed 5 cm distal to the medial epicondyle of the humerus and on the top of a circumferentially placed cotton cast. Receives: Procedure: Forearm IVRA block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of this study is to compare the analgesic effectivity of the arm intravenous regional anesthesia versus the forearm intravenous regional anesthesia.
the analgesic effectivity of these techniques (graded as "complete" or "incomplete") and divide the effectivity in 4 grades. Grade 1 and grade 2 will be considered "complete" blockade, while grade 3 and grade 4 will be considered "incomplete" blockade. Grade 1: complete motor and sensory blockade. Grade 2: partial motor blockade but no pain. Grade 3: partial motor blockade with mild pain requiring rescue local or opioid analgesia. Grade 4: incomplete motor and sensory blockade requiring sedation/conversion to general anesthesia.
Measured: surgery duration which is around 1.5 hour
Secondary outcomes (7)
Tourniquet time
Total time the tourniquet is inflated
Measured: From start of inflation until deflation of the tourniquet during surgery time which may last up to 90 minutes.
Onset time of analgesia
Measured: At injection of the local anaesthetic until complete blockade of the sensory nerves during surgery
Tourniquet tolerance time
Time required for the tourniquet to cause a painful sensation
Measured: From start of inflation until deflation of the tourniquet during surgery
Satisfaction with surgical conditions (bloodless field)
Satisfaction with surgical conditions (bloodless field): assessed by the surgeon with a 5-point scale. This scale is ranged (1, 2, 3, 4, 5) in which 1 stands for "completely dissatisfied" and 5 for "completely satisfied".
Measured: At the start of the surgical procedure
Intraoperative pain score
Intraoperative pain score
Measured: Every 5 minutes up to 1.5 hours during the surgical procedure
General satisfaction of the patient
General satisfaction of the patient with the anesthesia technique (measured via a 7-point Likert scale, with 1 being completely dissatisfied and 7 being completely satisfied)
Measured: Assessed on day 1 post surgery
Postoperative pain score: Numeric Rating Scale(NRS)
Postoperative pain score
Measured: Patients will be observed and data recording will be done every 2 hours for the first 24 hours for postoperative pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous Anesthetic Agent OverdoseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448845
- Sponsor's protocol ID
- FMASU MD 148/2023
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Arm Intravenous Regional Anesthesia Versus Forearm Intravenous Regional Anesthesia in Patients Undergoing Hand and Wrist Surgery. A Randomized Comparative Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06448845
- Acronym / sponsor ID
- FMASU MD 148/2023
- Keywords
- Forearm Tourniquet, Intravenous Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 7 Jun 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.
The technique of intravenous regional analgesia using a tourniquet consisting of two cuffs over the upper arm is a well-known procedure, With the tourniquet being conventionally placed over the upper arm, a relatively high dose of local anaesthetic drug is required and occasionally systemic toxic reactions have occurred.
The purpose of the present study is to establish the efficacy of the technique of intravenous regional analgesia with a forearm tourniquet using reduced doses of lidocaine.
Detailed description
Several ways of anesthesia can be used to perform hand surgery, being general anesthesia, intravenous regional anesthesia as well as locoregional anesthesia. Locoregional anesthesia and intravenous regional anesthesia are often performed since patients can be discharged from the hospital more rapidly. A conventional Biers block is performed using a tourniquet on the upper arm to create a bloodless field and to contain the anesthetics within the surgical area.
A mini-Biers block in which the tourniquet is placed on the forearm, has been shown to be a safe and effective way of anesthesia to perform hand and wrist surgery. By using this type of anesthesia, the dose of the anesthetic can be reduced compared to a conventional Bier's block which reduces the risk of systemic toxicity reactions.
Intravenous regional anesthesia (IVRA) or Bier's Block is a simple and effective but underused anesthetic technique for hand and wrist surgery, This technique, introduced by Dr.August Bier in1908, provides complete anesthesia as well as a bloodless field during surgery.
Traditionally, an upper arm tourniquet has been used to sequester the local anesthetic and to create a bloodless Surgical field. Major complications after IVRA with an upper arm tourniquet are rare but are mostly related to local anesthetic systemic toxicity after release of the tourniquet.
Use of a forearm tourniquet has been introduced in 1978 and comes with the big advantage of lower (non-toxic) local anesthetic dosage requirement to produce a good quality of analgesia.
Consequently, there is no minimal tourniquet inflation time after forearm IVRA. In addition ,it has been postulated that sensory onset time after forearm IVRA may be shorter than after upper arm IVRA. With these two features forearm IVRA may be the ideal anesthetic technique for short surgery of hand and wrist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Arm IVRA) 70 patients | Active comparator | Procedure: Arm intravenous regional anesthesiaAfter placement of the upper arm and forearm tourniquets and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the arm tourniquet cuff is inflated to a pressure of 250 mmHg. The double arm cuff pneumatic pressure tourniquet is placed immediately above the elbow crease and on the top of a circumferentially placed cotton cast padding before inflation. |
| Group F (Forearm IVRA) 70 patients | Active comparator | Procedure: Forearm IVRA blockAfter placement of the forearm double tourniquet and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the forearm tourniquet cuff is inflated to a pressure of 250 mmHg. The forearm tourniquet will be placed 5 cm distal to the medial epicondyle of the humerus and on the top of a circumferentially placed cotton cast. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of American Society of Anesthesiologists (ASA) physical status I to II.
- Both sexes.
- ≥ 21 to 65 years.
- scheduled for elective hand and wrist surgeries.
Key exclusion criteria (8 listed)
- American society of Anesthesiologists (ASA) physical status ≥3 or BMI ≥40
- Patients will do bilateral hand surgery
- Local site infection.
- Allergy to local anesthetics.
- Patient refusal
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 |
|---|---|---|
| Arm intravenous regional anesthesiaAlso: Bier's BlockAfter placement of the upper arm and forearm tourniquets and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the arm tourniquet cuff is inflated to a pressure of 250 mmHg. The double arm cuff pneumatic pressure tourniquet is placed immediately above the elbow crease and on the top of a circumferentially placed cotton cast padding before inflation. Subsequently, tourniquet failure is ruled out by observing the absence of distal circulation and 40 ml 0.5% lidocaine is slowly injected through the intravenous cannula on the dorsum of the hand. The tourniquet remained inflated for 60 minutes from injection of lidocaine to reduce the risk of local anesthetic systemic toxicity (LAST) | Procedure or surgery | Group A (Arm IVRA) 70 patients |
| Forearm IVRA blockAlso: Mini Bier's BlockAfter placement of the forearm double tourniquet and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the forearm tourniquet cuff is inflated to a pressure of 250 mmHg. The forearm tourniquet will be placed 5 cm distal to the medial epicondyle of the humerus and on the top of a circumferentially placed cotton cast. Subsequently, tourniquet failure is ruled out by observing the distal circulation and 25 ml 0.5% lidocaine is slowly injected through the intravenous cannula on the dorsum of the hand. | Procedure or surgery | Group F (Forearm IVRA) 70 patients |
Primary outcome
The primary aim of this study is to compare the analgesic effectivity of the arm intravenous regional anesthesia versus the forearm intravenous regional anesthesia.
Time frame: surgery duration which is around 1.5 hour
the analgesic effectivity of these techniques (graded as "complete" or "incomplete") and divide the effectivity in 4 grades. Grade 1 and grade 2 will be considered "complete" blockade, while grade 3 and grade 4 will be considered "incomplete" blockade. Grade 1: complete motor and sensory blockade. Grade 2: partial motor blockade but no pain. Grade 3: partial motor blockade with mild pain requiring rescue local or opioid analgesia. Grade 4: incomplete motor and sensory blockade requiring sedation/conversion to general anesthesia.
7 secondary outcomes
Tourniquet time
Time frame: From start of inflation until deflation of the tourniquet during surgery time which may last up to 90 minutes.
Onset time of analgesia
Time frame: At injection of the local anaesthetic until complete blockade of the sensory nerves during surgery
Tourniquet tolerance time
Time frame: From start of inflation until deflation of the tourniquet during surgery
Satisfaction with surgical conditions (bloodless field)
Time frame: At the start of the surgical procedure
Intraoperative pain score
Time frame: Every 5 minutes up to 1.5 hours during the surgical procedure
General satisfaction of the patient
Time frame: Assessed on day 1 post surgery
Postoperative pain score: Numeric Rating Scale(NRS)
Time frame: Patients will be observed and data recording will be done every 2 hours for the first 24 hours for postoperative pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
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 Arm intravenous regional anesthesia and Forearm IVRA block in people with Intravenous Anesthetic Agent Overdose and Hand Injury Wrist, run by Ain Shams 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 8 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: status not confirmed, as of the sponsor's last update on 7 Jun 2024. 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?
Results are not available in the source record.
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 primary aim of this study is to compare the analgesic effectivity of the arm intravenous regional anesthesia versus the forearm intravenous regional anesthesia. (time frame: surgery duration which is around 1.5 hour). 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 7 Jun 2024.