Early Versus Late Deflation of Distal Tourniquet in IVRA With and Without Ketorolac in Hand & Forearm Surgery

NCT ID: NCT05234619

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-06-01

Brief 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. 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.

Conditions

Hand Injuries With Intravenous Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group one ( lidocaine or control LE ) Early deflation

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.

Group Type: ACTIVE_COMPARATOR

Group one ( lidocaine or control LE ) Early deflation

Intervention Type: DRUG

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 deflation

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.

Group Type: ACTIVE_COMPARATOR

Group two ( lidocaine , ketorolac LKE ) Early deflation

Intervention Type: DRUG

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 deflation

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.

Group Type: ACTIVE_COMPARATOR

Group three ( lidocaine or control LL ) Late deflation

Intervention Type: DRUG

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 deflation

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.

Group Type: ACTIVE_COMPARATOR

Group four ( lidocaine , ketorolac LKL ) Late deflation

Intervention Type: DRUG

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 .

Interventions

Group one ( lidocaine 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

Intervention Type: DRUG

Group two ( lidocaine , ketorolac 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

Intervention Type: DRUG

Group three ( lidocaine 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 .

Intervention Type: DRUG

Group four ( lidocaine , ketorolac 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 .

Intervention Type: DRUG

Other Intervention Names

Group one ( xyloxaine or control LE ) Early deflation; Group two ( xylocaine , Toradol LKE ) Early deflation; Group three ( xylocaine or control LL ) Late deflation; Group four ( xylocaine , toradol LKL ) Late deflation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Salah Ismail

resident doctor at anesthesiology& intensive care unit and pain managment department sohag university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed E Elsaeed

Role: STUDY_DIRECTOR

Head of Anesthesiology & intensive care unit department

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

References

Rosen MA. Anesthesiology: bupivacaine toxicity. West J Med. 1986 May;144(5):598-9. No abstract available.

Reference Type: BACKGROUND

PMID: 18749978 (View on PubMed)

Guay 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.

Reference Type: BACKGROUND

PMID: 20122591 (View on PubMed)

Zahavi 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.

Reference Type: BACKGROUND

PMID: 24591833 (View on PubMed)

Other Identifiers

Soh-Med-21-11-01

Identifier Type: -

Identifier Source: org_study_id