Adjuncts to IVRA, a Comparison Between Ketorolac and Paracetamol

Study Overview
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Brief Summary
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The study was planned to compare the effect of ketorolac 20 mg to 300 mg of paracetamol when added to lidocaine 3 mg/kg for Intravenous regional anaesthesia.

Detailed Description
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All patients were premedicated 15 minutes before the surgical procedure with I.V. 0.06mg/kg of midazolam. In the operating room, patients were monitored for non invasive blood pressure (NIBP), oxygen saturation (Spo2) and pulse rate (PR). Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers. The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist. During surgery if patient reported pain during operation (VAS 4 or greater) inj. fentanyl 1 μg/kg was given and total amount used was recorded. Postoperatively patients were questioned for pain and if VAS > 4, 75 mg intramuscular diclofenac was given.Total amount used was recorded.

Official Title
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Adjuncts to Intravenous Regional Anaesthesia, a Comparison Between Ketorolac and Paracetamol

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Ketorolac
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anaesthesiologists (ASA) physical status I or II, who will be scheduled for surgery of the hand or the forearm were included in this study after informed consent Exclusion Criteria: Severe Raynaud's Disease Sickle Cell Disease Crush injury to the limb A history of allergic reaction to lidocaine Liver disease or kidney disease Significant cardiovascular disease Highly nervous and uncooperative patients Patient with history of opioid dependence Drug or alcohol abuse Psychiatric disorder Neurological diseases

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Patients in group C will receive 3 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml. | Drug: Lidocaine<br>* Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist.<br>|
| Experimental: Lidocaine+ Ketorolac<br>Patients in group K receive 3 mg/kg of lidocaine 2% + 20 mg ketorolac diluted with saline to a total volume of 40 ml. | Drug: Lidocaine<br>* Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist.<br>Drug: Ketorolac<br>* Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist.<br>|
| Experimental: Lidocaine+Paracetamol<br>Patients in group P will receive 3 mg/kg of lidocaine 2% + 300 mg paracetamol diluted with saline to a total volume of 40 ml. | Drug: Lidocaine<br>* Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist.<br>Drug: paracetamol<br>* Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to first analgesic request. | The time from tourniquet release until first patient request for analgesic | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensory block | Onset of sensory block will be assessed by a pin prick performed at 1 minute interval in the dermatomal sensory distribution of the medial and lateral ante brachial cutaneous, ulnar, median and radial nerves. Sensory block onset time will be recorded as time elapsed from injection of drug to sensory block achieved in all dermatomes | 1 year | 
| motor block | Onset of motor block will be assessed by asking the subject to flex and extend his/her wrist and fingers.Complete motor block will be recorded when no voluntary movement will be possible. | 1 year |