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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hand Injuries With Intravenous Regional Anesthesia
• Intervention / Treatment: Drug: Group one ( lidocaine or control LE ) Early deflation; Drug: Group two ( lidocaine , ketorolac LKE ) Early deflation; Drug: Group three ( lidocaine or control LL ) Late deflation; Drug: Group four ( lidocaine , ketorolac LKL ) Late deflation

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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; Other Names: Group one ( xyloxaine or control LE ) Early deflation
Active Comparator: 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.	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; Other Names: Group two ( xylocaine , Toradol LKE ) Early deflation
Active Comparator: 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.	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 .; Other Names: Group three ( xylocaine or control LL ) Late deflation
Active Comparator: 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.	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 .; Other Names: Group four ( xylocaine , toradol LKL ) Late deflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	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 .	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 .	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	6 months

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Director: Ahmed E Elsaeed, Head of Anesthesiology & intensive care unit department

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: November 14, 2021
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ketorolac; Ketorolac Tromethamine
• Other Study ID Numbers: Soh-Med-21-11-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Early versus Late deflation of Distal tourniquet in Intravenous Regional Anesthesia With and without Ketorolac in Hand & Forearm surgery
• IPD Sharing Time Frame: 6 months
• IPD Sharing Access Criteria: Early versus Late deflation of Distal tourniquet in Intravenous Regional Anesthesia With and without Ketorolac in Hand & Forearm surgery
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No