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Adjuncts to IVRA, a Comparison Between Ketorolac and Paracetamol

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Lidocaine
Ketorolac
paracetamol
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

17 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Omar Ali

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Lidocaine

Lidocaine+ Ketorolac

Lidocaine+Paracetamol

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

The time to first analgesic request.
The time from tourniquet release until first patient request for analgesic

Secondary Outcome Measures

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
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.

Full Information

First Posted
March 21, 2018
Last Updated
July 22, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03485625
Brief Title
Adjuncts to IVRA, a Comparison Between Ketorolac and Paracetamol
Official Title
Adjuncts to Intravenous Regional Anaesthesia, a Comparison Between Ketorolac and Paracetamol
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
April 28, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Patients in group C will receive 3 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.
Arm Title
Lidocaine+ Ketorolac
Arm Type
Experimental
Arm 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.
Arm Title
Lidocaine+Paracetamol
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Description
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 Outcome Measure Information:
Title
The time to first analgesic request.
Description
The time from tourniquet release until first patient request for analgesic
Time Frame
1 year
Secondary Outcome Measure Information:
Title
sensory block
Description
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
Time Frame
1 year
Title
motor block
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Abdel-Baki Abdel-Rahman, Lecturer of anaesthesia
Organizational Affiliation
Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Omar Ali
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Adjuncts to IVRA, a Comparison Between Ketorolac and Paracetamol

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