Skip to main content
OpenTrials
Completed

NCT Number: NCT03485625

Adjuncts to IVRA, a Comparison Between Ketorolac and Paracetamol

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

17 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Omar Ali

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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.

Ketorolac

Drug

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.

Paracetamol

Drug

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.

Primary outcomes

  1. The time to first analgesic request.

    Time frame: 1 year

    The time from tourniquet release until first patient request for analgesic

Secondary outcomes

  1. sensory block

    Time frame: 1 year

    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

  2. motor block

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2018
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.