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
About this trial
This is an interventional treatment trial for Postoperative Pain
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
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
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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