Modulation of Propofol Injection Pain by Rubbing and Distraction

NCT ID: NCT06643832

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-16
• Study Completion Date: 2025-02-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Rubbing Distraction group

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.

Group Type: EXPERIMENTAL

Rubbing Distraction

Intervention Type: 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 group

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

Group Type: ACTIVE_COMPARATOR

Lidocaine (drug)

Intervention Type: DRUG

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

Saline group

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Lidocaine (drug)

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

Intervention Type: DRUG

Saline

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Osama Rehab

Lecturer of anesthesiology, surgical Intensive care and pain medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospitals

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

36264PR878/9/24

Identifier Type: -

Identifier Source: org_study_id