ClinicalTrials.gg
CompletedNCT03485625Updated Jul 24, 2020

Adjuncts to IVRA, a Comparison Between Ketorolac and Paracetamol

A Phase 3 interventional study of Lidocaine and Ketorolac in Postoperative Pain, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 17 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-07-24.

Sponsored by Assiut University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
17 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 68 studies testing ketorolac in Pain, Postoperative — 9 open to participants now, 9 under way, 3 of them phase 3. Ketorolac · Pain, Postoperative.

Enrollment
42nd of 68
60 · median 77
Started
2018
with 2 others
Phase 3
14 of 68
2 open now
Registered
33rd of 68
by date
Lead sponsor
2 of 68
Assiut University

Among the 68 studies testing ketorolac in Pain, Postoperative, this one is the 42nd largest by enrollment, is one of 3 that started in 2018, is one of 14 in phase 3, and was the 33rd registered.

By phase

68 studies; the count open now beside each. This study's row is marked.

Phase 425 · 3 open
Phase 3this study14 · 2 open
No phase12 · 1 open
Phase 28 · 0 open
Phase 16 · 1 open
Phase 2/32 · 1 open
Phase 1/21 · 1 open

By the year they started

First in 2000; this study’s year is marked. 3 started in 2018.

Size and results

Median enrollment 77 across the 68 interventional studies. Of the 47 that completed or were terminated, 20 (43%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 68 studies testing ketorolac in Pain, Postoperative, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Postoperative Pain

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04

Who can participate

Ages eligible
17 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Lidocaine

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

    Drug: Lidocaine

  • Experimental
    Lidocaine+ Ketorolac

    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

  • Experimental
    Lidocaine+Paracetamol

    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

  • 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.

  • 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. The time to first analgesic request.

    The time from tourniquet release until first patient request for analgesic

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

07

Study locations

1 site
  • Omar Ali
    Assiut, 71515, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03485625
Lead sponsor
Assiut University
Responsible party
Omar Rabiee Ali (Resident doctor at the department of anaesthesiology and ICU, Assiut University) — Principal investigator
First posted
Apr 2, 2018
Start date
Mar 21, 2018
Primary completion
Apr 28, 2019
Completion
Aug 20, 2019
Last update
Jul 24, 2020

Study contacts

Khaled Abdel-Baki Abdel-Rahman, Lecturer of anaesthesia
study chair · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Ketorolac · Acetaminophen

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