Hand Injuries With Intravenous Regional AnesthesiaNCT05234619
Early Versus Late Deflation of Distal Tourniquet in IVRA With and Without Ketorolac in Hand & Forearm Surgery
A study testing Group two ( lidocaine , ketorolac LKE ) Early deflation and Group four ( lidocaine , ketorolac LKL ) Late deflation in people with Hand Injuries With Intravenous Regional Anesthesia, run by Sohag University at 1 site in Egypt.
Trial summary
Bier block , or intravenous regional anesthesia (IVRA), is a method of anesthesia for upper extremity surgeries. IVRA was first described by August Bier in 1908, and after a period of latency, it began to gain widespread use after Holmes reemphasized its use in 1963. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries With Intravenous Regional Anesthesia
- What is being tested?
- Group two ( lidocaine , ketorolac LKE ) Early deflation and Group four ( lidocaine , ketorolac LKL ) Late deflation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jun 2022
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A normal healthy patient or A patient with mild systemic disease
- Aged between 20 and 70 years
- Male or female
- Schedueled for hand or forearm surgery
Who cannot join
- Severe Raynaud's Disease (intermittent arteriolar vasospasm of the distal limbs after cold or emotional stimuli).
- Sickle Cell Disease (IVRA is relatively contraindicated, unless meticulous exsanguination of the limb takes place prior to cuff inflation).
- Crush injury to the limb, IVRA may provoke further tissue damage secondary to hypoxia.
- Patients should be fasting, as there may be a possibility of conversion to a general anaesthetic, alternatively the patient may require sedation in addition to IVRA to improve co-operation.
- Psychic, uncooperative patients.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Late Deflation of Distal Tourniquet in Intravenous Regional Anesthesia With and Without Ketorolac in Hand & Forearm Surgery
Bier block , or intravenous regional anesthesia (IVRA), is a method of anesthesia for upper extremity surgeries. IVRA was first described by August Bier in 1908, and after a period of latency, it began to gain widespread use after Holmes reemphasized its use in 1963. Bier blocks are technically easy to perform, and the rates for successful anesthesia approach 98%. Furthermore, when compared with brachial plexus blocks for outpatient hand and upper extremity surgery, IVRA may realize lower costs and faster postanesthesia recovery.
Although a reliable source of anesthesia, IVRA has been associated with some disadvantages. Some patients cannot tolerate the tourniquet-mediated arm pain, and there are also reports of neurologic injury and compartment syndrome caused by the tourniquet. Perhaps the most serious complications associated with IVRA relate to the potential systemic toxicity of the local anesthetics used. If the local anesthetic gains access to a patient's systemic circulation, the central nervous system (CNS) and cardiovascular system can be affected. The CNS is usually affected first, with symptoms including dizziness, tinnitus, perioral paresthesia, and seizures. Anesthetic-induced toxicity of the cardiovascular system may manifest as hypotension, bradycardia, arrhythmias, or cardiac arrest.
Historically, the tourniquet used in IVRA is left inflated for a minimum of 20 minutes. Theoretically, this allows time for the local anesthetic to bind to the tissues and, consequently, prevent a large bolus of drug from entering the systemic circulation. However, this tourniquet time appears to be arbitrary, and no safe time interval between anesthetic drug injection and tourniquet deflation has been established.
Read the detailed description
This is a prospective Cohort , controlled , single-blinded , randomized study will be carried out at the department of Anesthesia of Sohag University hospital .
This study will be conducted on 80 trauma patients who will be present for both elective and emergency Hand and Forearm surgery ..
The patients will be allocated to one of four groups :
Early deflation occurs after 20 minutes of induction of IVRA Late deflation occurs after 40 - 60 minutes of induction of IVRA
- Group one ( lidocaine or control LE ) Early deflation
- Group two ( lidocaine , ketorolac LKE) Early deflation
- Group three ( lidocaine Or control LL ) Late deflation
- Group four ( lidocaine , ketorolac LKL ) Late deflation
After establishing noninvasive arterial blood pressure, ECG, peripheral oxygen saturation monitoring, two venous cannulae will be inserted: one in a vein in the dorsum of operative hand and the other in the opposite hand for crystalloid infusion.
The opposite arm will be elevated for 2 minutes, and using an Esmarch bandage, the venous capacitance of the arm will be emptied. Then, a double-pneumatic tourniquet will be applied. The proximal tourniquet will be inflated to a pressure of 250 mmHg and circulatory isolation of the arm will be confirmed by inspection, lack of radial pulse and failure of pulse oximetry tracing of ipsilateral index finger then Esmarch bandage will be released.
- Being tested
- Group one ( lidocaine or control LE ) Early deflation, Group two ( lidocaine , ketorolac LKE ) Early deflation, Group three ( lidocaine or control LL ) Late deflation, Group four ( lidocaine , ketorolac LKL ) Late deflation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group one ( lidocaine or control LE ) Early deflationDrug
Also called Group one ( xyloxaine or control LE ) Early deflation
This will be conducted on 20 trauma patients group one who will be present for both elective and emergency Hand and Forearm surgery After establishing noninvasive arterial blood pressure, ECG, peripheral oxygen saturation monitoring, two venous cannulae will be inserted: one in a vein in the dorsum of operative hand and the other in the opposite hand for crystalloid infusion.
The opposite arm will be elevated for 2 minutes, and using an Esmarch bandage, the venous capacitance of the arm will be emptied. Then, a double-pneumatic tourniquet will be applied. The proximal tourniquet will be inflated to a pressure of 250 mmHg and circulatory isolation of the arm will be confirmed by inspection, lack of radial pulse and failure of pulse oximetry tracing of ipsilateral index finger then Esmarch bandage will be released then induction of lidocaine for intravenous regional anesthesia ( Bier block ) and Early deflation of distal tourniquet occurs after 20 minutes of IVRA induction
Group two ( lidocaine , ketorolac LKE ) Early deflationDrug
Also called Group two ( xylocaine , Toradol LKE ) Early deflation
As the first intervention this will be conducted on group two but ketorolac will be combined with lidocaine in intravenous regional anesthesia
Group three ( lidocaine or control LL ) Late deflationDrug
Also called Group three ( xylocaine or control LL ) Late deflation
As the first intervention this will be conducted on group three but late deflation of distal tourniquet in intravenous regional anesthesia after 40 minutes of induction of lidocaine for IVRA .
Group four ( lidocaine , ketorolac LKL ) Late deflationDrug
Also called Group four ( xylocaine , toradol LKL ) Late deflation
As the first intervention this will be conducted on group four but late deflation of distal tourniquet in intravenous regional anesthesia after 40 minutes of induction of lidocaine and ketorolac for IVRA .
| Study group | Role | What they receive |
|---|---|---|
| Group one ( lidocaine or control LE ) Early deflation | Active comparator | Patients in group one (lidocaine or control group LE = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) then distal tourniquet deflation occurs after 20 minutes. Receives: Drug: Group one ( lidocaine or control LE ) Early deflation |
| Group two ( lidocaine , ketorolac LKE) Early deflation | Active comparator | Patients in group two (lidocaine ketorolac LKE = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) plus ketorolac 0.5mg/kg (maximum 30mg) then distal tourniquet deflation occurs after 20 minutes. Receives: Drug: Group two ( lidocaine , ketorolac LKE ) Early deflation |
| Group three ( lidocaine Or control LL ) Late deflation | Active comparator | Patients in group three (lidocaine or control group LL = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) then distal tourniquet deflation occurs after 40 minutes. Receives: Drug: Group three ( lidocaine or control LL ) Late deflation |
| Group four ( lidocaine , ketorolac LKL ) Late deflation | Active comparator | Patients in group four (lidocaine ketorolac LKL = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) plus ketorolac 0.5mg/kg (maximum 30mg) then distal tourniquet deflation occurs after 40 minutes. Receives: Drug: Group four ( lidocaine , ketorolac LKL ) Late deflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of intravenous regional anesthesia assessed by visual analogue scale
Assessment of lidocaine as anesthetic in IVRA on 40 participants on the quality of the sensorial and motor block .
Measured: 6 months
Duration of intravenous regional anesthesia
Assessment of lidocaine as anesthetic in IVRA on 40 participants on the duration of the sensorial and motor block .
Measured: 6 months
Efficacy of intravenous regional anesthesia as regard tolerance of tourniquet pain .
Assessment of lidocaine as anesthetic in IVRA on 40 participants as regard tourniquet pain during hand and forearm surgery .
Measured: 6 months
Secondary outcomes (1)
Role of keterolac as adjuvant to lidocaine in intravenous regional anesthesia as intraoperative & postoperative analgesic
Assessment of ketorolac as analgesic to lidocaine for intravenous regional anesthesia ( IVRA ) in 40 participants as regard intraoperative and postoperative analgesa during hand and forearm surgery .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jan 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hand Injuries With Intravenous Regional AnesthesiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Salah Ismail, Sohag University
- Investigators
- Ahmed E Elsaeed, Study director, Head of Anesthesiology & intensive care unit department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234619
- Sponsor's protocol ID
- Soh-Med-21-11-01
- Status last verified
- Feb 2022
- First submitted
- 14 Nov 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Early versus Late deflation of Distal tourniquet in Intravenous Regional Anesthesia With and without Ketorolac in Hand \& Forearm surgery
Publications
Rosen MA. Anesthesiology: bupivacaine toxicity. West J Med. 1986 May;144(5):598-9. No abstract available.
PubMed 18749978Guay J. Adverse events associated with intravenous regional anesthesia (Bier block): a systematic review of complications. J Clin Anesth. 2009 Dec;21(8):585-94. doi: 10.1016/j.jclinane.2009.01.015.
PubMed 20122591Zahavi GS, Dannon P. Comparison of anesthetics in electroconvulsive therapy: an effective treatment with the use of propofol, etomidate, and thiopental. Neuropsychiatr Dis Treat. 2014 Feb 20;10:383-9. doi: 10.2147/NDT.S58330. eCollection 2014.
PubMed 24591833
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Deflation of Distal Tourniquet in Intravenous Regional Anesthesia With and Without Ketorolac in Hand & Forearm Surgery
- ClinicalTrials.gov ID
- NCT05234619
- Acronym / sponsor ID
- Soh-Med-21-11-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 10 Feb 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.
Bier block , or intravenous regional anesthesia (IVRA), is a method of anesthesia for upper extremity surgeries. IVRA was first described by August Bier in 1908, and after a period of latency, it began to gain widespread use after Holmes reemphasized its use in 1963. Bier blocks are technically easy to perform, and the rates for successful anesthesia approach 98%. Furthermore, when compared with brachial plexus blocks for outpatient hand and upper extremity surgery, IVRA may realize lower costs and faster postanesthesia recovery.
Although a reliable source of anesthesia, IVRA has been associated with some disadvantages. Some patients cannot tolerate the tourniquet-mediated arm pain, and there are also reports of neurologic injury and compartment syndrome caused by the tourniquet. Perhaps the most serious complications associated with IVRA relate to the potential systemic toxicity of the local anesthetics used. If the local anesthetic gains access to a patient's systemic circulation, the central nervous system (CNS) and cardiovascular system can be affected. The CNS is usually affected first, with symptoms including dizziness, tinnitus, perioral paresthesia, and seizures. Anesthetic-induced toxicity of the cardiovascular system may manifest as hypotension, bradycardia, arrhythmias, or cardiac arrest.
Historically, the tourniquet used in IVRA is left inflated for a minimum of 20 minutes. Theoretically, this allows time for the local anesthetic to bind to the tissues and, consequently, prevent a large bolus of drug from entering the systemic circulation. However, this tourniquet time appears to be arbitrary, and no safe time interval between anesthetic drug injection and tourniquet deflation has been established.
Detailed description
This is a prospective Cohort , controlled , single-blinded , randomized study will be carried out at the department of Anesthesia of Sohag University hospital .
This study will be conducted on 80 trauma patients who will be present for both elective and emergency Hand and Forearm surgery ..
The patients will be allocated to one of four groups :
Early deflation occurs after 20 minutes of induction of IVRA Late deflation occurs after 40 - 60 minutes of induction of IVRA
- Group one ( lidocaine or control LE ) Early deflation
- Group two ( lidocaine , ketorolac LKE) Early deflation
- Group three ( lidocaine Or control LL ) Late deflation
- Group four ( lidocaine , ketorolac LKL ) Late deflation
After establishing noninvasive arterial blood pressure, ECG, peripheral oxygen saturation monitoring, two venous cannulae will be inserted: one in a vein in the dorsum of operative hand and the other in the opposite hand for crystalloid infusion.
The opposite arm will be elevated for 2 minutes, and using an Esmarch bandage, the venous capacitance of the arm will be emptied. Then, a double-pneumatic tourniquet will be applied. The proximal tourniquet will be inflated to a pressure of 250 mmHg and circulatory isolation of the arm will be confirmed by inspection, lack of radial pulse and failure of pulse oximetry tracing of ipsilateral index finger then Esmarch bandage will be released.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group one ( lidocaine or control LE ) Early deflation | Active comparator | Drug: Group one ( lidocaine or control LE ) Early deflationPatients in group one (lidocaine or control group LE = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) then distal tourniquet deflation occurs after 20 minutes. |
| Group two ( lidocaine , ketorolac LKE) Early deflation | Active comparator | Drug: Group two ( lidocaine , ketorolac LKE ) Early deflationPatients in group two (lidocaine ketorolac LKE = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) plus ketorolac 0.5mg/kg (maximum 30mg) then distal tourniquet deflation occurs after 20 minutes. |
| Group three ( lidocaine Or control LL ) Late deflation | Active comparator | Drug: Group three ( lidocaine or control LL ) Late deflationPatients in group three (lidocaine or control group LL = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) then distal tourniquet deflation occurs after 40 minutes. |
| Group four ( lidocaine , ketorolac LKL ) Late deflation | Active comparator | Drug: Group four ( lidocaine , ketorolac LKL ) Late deflationPatients in group four (lidocaine ketorolac LKL = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) plus ketorolac 0.5mg/kg (maximum 30mg) then distal tourniquet deflation occurs after 40 minutes. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A normal healthy patient or A patient with mild systemic disease
- Aged between 20 and 70 years
- Male or female
- Schedueled for hand or forearm surgery
Key exclusion criteria (6 listed)
- Severe Raynaud's Disease (intermittent arteriolar vasospasm of the distal limbs after cold or emotional stimuli).
- Sickle Cell Disease (IVRA is relatively contraindicated, unless meticulous exsanguination of the limb takes place prior to cuff inflation).
- Crush injury to the limb, IVRA may provoke further tissue damage secondary to hypoxia.
- Patients should be fasting, as there may be a possibility of conversion to a general anaesthetic, alternatively the patient may require sedation in addition to IVRA to improve co-operation.
- Psychic, uncooperative patients.
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 |
|---|---|---|
| Group one ( lidocaine or control LE ) Early deflationAlso: Group one ( xyloxaine or control LE ) Early deflationThis will be conducted on 20 trauma patients group one who will be present for both elective and emergency Hand and Forearm surgery After establishing noninvasive arterial blood pressure, ECG, peripheral oxygen saturation monitoring, two venous cannulae will be inserted: one in a vein in the dorsum of operative hand and the other in the opposite hand for crystalloid infusion. The opposite arm will be elevated for 2 minutes, and using an Esmarch bandage, the venous capacitance of the arm will be emptied. Then, a double-pneumatic tourniquet will be applied. The proximal tourniquet will be inflated to a pressure of 250 mmHg and circulatory isolation of the arm will be confirmed by inspection, lack of radial pulse and failure of pulse oximetry tracing of ipsilateral index finger then Esmarch bandage will be released then induction of lidocaine for intravenous regional anesthesia ( Bier block ) and Early deflation of distal tourniquet occurs after 20 minutes of IVRA induction | Drug | Group one ( lidocaine or control LE ) Early deflation |
| Group two ( lidocaine , ketorolac LKE ) Early deflationAlso: Group two ( xylocaine , Toradol LKE ) Early deflationAs the first intervention this will be conducted on group two but ketorolac will be combined with lidocaine in intravenous regional anesthesia | Drug | Group two ( lidocaine , ketorolac LKE) Early deflation |
| Group three ( lidocaine or control LL ) Late deflationAlso: Group three ( xylocaine or control LL ) Late deflationAs the first intervention this will be conducted on group three but late deflation of distal tourniquet in intravenous regional anesthesia after 40 minutes of induction of lidocaine for IVRA . | Drug | Group three ( lidocaine Or control LL ) Late deflation |
| Group four ( lidocaine , ketorolac LKL ) Late deflationAlso: Group four ( xylocaine , toradol LKL ) Late deflationAs the first intervention this will be conducted on group four but late deflation of distal tourniquet in intravenous regional anesthesia after 40 minutes of induction of lidocaine and ketorolac for IVRA . | Drug | Group four ( lidocaine , ketorolac LKL ) Late deflation |
Primary outcome
Efficiency of intravenous regional anesthesia assessed by visual analogue scale
Time frame: 6 months
Assessment of lidocaine as anesthetic in IVRA on 40 participants on the quality of the sensorial and motor block .
Duration of intravenous regional anesthesia
Time frame: 6 months
Assessment of lidocaine as anesthetic in IVRA on 40 participants on the duration of the sensorial and motor block .
Efficacy of intravenous regional anesthesia as regard tolerance of tourniquet pain .
Time frame: 6 months
Assessment of lidocaine as anesthetic in IVRA on 40 participants as regard tourniquet pain during hand and forearm surgery .
1 secondary outcome
Role of keterolac as adjuvant to lidocaine in intravenous regional anesthesia as intraoperative & postoperative analgesic
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Background: PubMed 18749978Rosen MA. Anesthesiology: bupivacaine toxicity. West J Med. 1986 May;144(5):598-9. No abstract available.
- Background: PubMed 20122591Guay J. Adverse events associated with intravenous regional anesthesia (Bier block): a systematic review of complications. J Clin Anesth. 2009 Dec;21(8):585-94. doi: 10.1016/j.jclinane.2009.01.015.
- Background: PubMed 24591833Zahavi GS, Dannon P. Comparison of anesthetics in electroconvulsive therapy: an effective treatment with the use of propofol, etomidate, and thiopental. Neuropsychiatr Dis Treat. 2014 Feb 20;10:383-9. doi: 10.2147/NDT.S58330. eCollection 2014.
- Individual participant dataSharing planned: Yes. Early versus Late deflation of Distal tourniquet in Intravenous Regional Anesthesia With and without Ketorolac in Hand \& Forearm 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.
Ahmed E Elsaeed study director
Head of Anesthesiology & intensive care unit department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group two ( lidocaine , ketorolac LKE ) Early deflation and Group four ( lidocaine , ketorolac LKL ) Late deflation in people with Hand Injuries With Intravenous Regional Anesthesia, run by Sohag 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 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: status not confirmed, as of the sponsor's last update on 10 Feb 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 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?
Efficiency of intravenous regional anesthesia assessed by visual analogue scale (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT05234619, which also lists 3 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 10 Feb 2022.