Adjuncts to IVRA, a Comparison Between Ketorolac and Paracetamol

Assiut University

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: paracetamol; Drug: Ketorolac; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03485625

Bier's block

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 17 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Lidocaine

Experimental group

Description:

Patients in group C will receive 3 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.

Treatment:

Drug: Lidocaine

Lidocaine+ Ketorolac

Experimental group

Description:

Patients in group K receive 3 mg/kg of lidocaine 2% + 20 mg ketorolac diluted with saline to a total volume of 40 ml.

Treatment:

Drug: Ketorolac

Drug: Lidocaine

Lidocaine+Paracetamol

Experimental group

Description:

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.

Treatment:

Drug: paracetamol

Drug: Lidocaine