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NCT Number: NCT06643832

Modulation of Propofol Injection Pain by Rubbing and Distraction

This prospective randomized controlled study will be conducted to evaluate the effects of rubbing and distraction on the incidence and severity of propofol injection pain and compare them with the standard intravenous lidocaine method.

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Key information

Conditions

Propofol Injection Distraction Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rubbing Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

About this study

Propofol has become one of the most common anesthetic agents used for sedation, induction, and maintenance of anesthesia because of its unique pharmacological properties. Pain during bolus injection is a major drawback with an incidence as high as 80%-90% in an untreated patient.

One of the most effective factors that alleviate the injection pain involves pretreatment with lidocaine.

Spinal modulation of pain is explained by the melzack gate control theory, it proposed that stimulation of A beta fibers by touch and vibration, modulate the dorsal horn "gate" and therefore the nociceptive input from the periphery could be reduced. (5) Regarding the use of this concept for managing propofol pain, only one study was conducted and revealed that rubbing didn't decrease the incidence but significantly decreased the severity of pain.

Distraction is a method of removing attention; so, it modifies cognitive pain perceptions by altering nociceptive responses and triggering an internal pain-suppressing system. Therefore, it causes a decrease in the activation of areas in the brain (e.g.: thalamus and insula) which contribute significantly to pain perception. we will combine rubbing and distraction, as methods for spinal and supra-spinal pain modulation, to evaluate their effects on propofol injection pain and compare them with the standard intravenous lidocaine method.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of either sex
  • American Society Anesthesiologists physical (ASA) status I-II
  • age between 18-65 years old
  • undergoing elective surgeries under general anesthesia using Propofol for anesthetic induction.

Exclusion criteria

  • Allergy to experimental drugs
  • Abuse of alcohol, analgesia, or sedative antidepressant
  • Difficulty in communication
  • Chronic pain syndromes, thrombophlebitis, neurological disease, and analgesic administration at the time of the study

Treatment and study plan

Rubbing Distraction

Other

gently touching on proximal part of the IV injection site with the palm of the hand extending to the elbow. This will be started 5 seconds before propofol injection (not mixed with any drug) and continued until loss of consciousness. Also, a mobile video with duration of 10 seconds will be used for distraction and will be started 5 seconds before propofol injection so as to be ended at the time of first pain assessment.

Lidocaine (drug)

Drug

lidocaine will be used by mixing it with the propofol before intravenous injection

Saline

Other

intravenous propofol will be given without mixing with any drug (except for 2 ml saline to ensure blindness of the outcome assessor).

Primary outcomes

  1. Incidence of propofol injection pain

    Time frame: Pain will be evaluated every 5 seconds during the propofol injection until loss of concioussness. The highest pain score will be recorded

    Pain will be graded using a four-point scale: 0 = no pain, 1 = mild pain (pain reported only in response to questioning without any behavioral signs), 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign or pain reported spontaneously without questioning), and 3 = severe pain (i.e., strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).

Secondary outcomes

  1. Degree of pain

    Time frame: every 5 seconds during injection and the highest value will be recorded.

    Pain will be graded using a four-point scale: 0 = no pain, 1 = mild pain (pain reported only in response to questioning without any behavioral signs), 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign or pain reported spontaneously without questioning), and 3 = severe pain (i.e., strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears)

  2. Recall of pain

    Time frame: 1 hour after surgery

    Patients who will report pain during propofol injection will be asked if they recalled this pain

  3. adverse effects

    Time frame: 1 hour after surgery

    Like redness or edema will be examined at the site of propofol injection

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Spinal and Supra-spinal Modulation of Propofol Injection Pain by Rubbing and Distraction: A Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Feb 18, 2025

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.

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