Modulation of Propofol Injection Pain by Rubbing and Distraction

Tanta University

Status: Completed

Conditions: Rubbing; Distraction; Pain; Propofol Injection

Treatments: Other: Rubbing Distraction; Drug: Lidocaine (drug); Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06643832

36264PR878/9/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 3 patient groups, including a placebo group

Rubbing Distraction group

Experimental group

Description:

rubbing and gently touching on proximal part of the intravenous 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.

Treatment:

Other: Rubbing Distraction

Lidocaine group

Active Comparator group

Description:

patients will receive intravenous propofol mixed with 2ml of lidocaine 2% (40mg) before injection.

Treatment:

Drug: Lidocaine (drug)

Saline group

Placebo Comparator group

Description:

patients will receive intravenous propofol not mixed with any drug (except for 2 ml of saline to ensure blindness of the outcome assessor).

Treatment:

Other: Saline