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

NCT05234619 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-02-10

No results posted yet for this study

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.

Conditions

  • Hand Injuries With Intravenous Regional Anesthesia

Interventions

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

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

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 .

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 .

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • Ahmed E Elsaeed · Head of Anesthesiology & intensive care unit department

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234619 on ClinicalTrials.gov