Adjuncts to IVRA, a Comparison Between Ketorolac and Paracetamol

NCT03485625 | Completed Phase 3

• 1 other identifier: Bier's block
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• The time to first analgesic request.

  The time from tourniquet release until first patient request for analgesic

  1 year

Secondary Outcomes (2)

• sensory block

  1 year

• motor block

  1 year

Study Arms (3)

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine

Lidocaine+ Ketorolac

EXPERIMENTAL

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; Drug: Ketorolac

Lidocaine+Paracetamol

EXPERIMENTAL

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; Drug: paracetamol

Interventions

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.

Lidocaine; Lidocaine+ Ketorolac; Lidocaine+Paracetamol

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.

Lidocaine+ Ketorolac

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.

Lidocaine+Paracetamol

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Omar Ali

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Ketorolac; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Khaled Abdel-Baki Abdel-Rahman, Lecturer of anaesthesia

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at the department of anaesthesiology and ICU

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 2, 2018
• Study Start: March 21, 2018
• Primary Completion: April 28, 2019
• Study Completion: August 20, 2019
• Last Updated: July 24, 2020

Record last verified: 2018-03

Locations

EG (1)