NCT06643832

Modulation of Propofol Injection Pain by Rubbing and Distraction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Propofol Injection
• Pain
• Rubbing
• Distraction

Interventions

Type	Name	Description
OTHER	Rubbing Distraction	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.
DRUG	Lidocaine (drug)	lidocaine will be used by mixing it with the propofol before intravenous injection
OTHER	Saline	intravenous propofol will be given without mixing with any drug (except for 2 ml saline to ensure blindness of the outcome assessor).

Timeline

• Start date: 2024-10-16
• Primary completion: 2025-02-17
• Completion: 2025-02-17
• First posted: 2024-10-16
• Last updated: 2025-02-18

Locations

1 site across 1 country: Egypt