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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Distraction; Propofol Injection; Rubbing
• Intervention / Treatment: Other: Rubbing Distraction; Drug: Lidocaine (drug); Other: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31527
      • Tanta University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Lidocaine group; patients will receive intravenous propofol mixed with 2ml of lidocaine 2% (40mg) before injection.	Drug: Lidocaine (drug); lidocaine will be used by mixing it with the propofol before intravenous injection
Placebo Comparator: 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).	Other: Saline; intravenous propofol will be given without mixing with any drug (except for 2 ml saline to ensure blindness of the outcome assessor).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of propofol injection pain	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).	Pain will be evaluated every 5 seconds during the propofol injection until loss of concioussness. The highest pain score will be recorded

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	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)	every 5 seconds during injection and the highest value will be recorded.
Recall of pain	Patients who will report pain during propofol injection will be asked if they recalled this pain	1 hour after surgery
adverse effects	Like redness or edema will be examined at the site of propofol injection	1 hour after surgery

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Actual): February 17, 2025
• Study Completion (Actual): February 17, 2025

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pain, Modulation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: 36264PR878/9/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the corresponding author
• IPD Sharing Time Frame: After completion of the study
• IPD Sharing Access Criteria: The data will be available upon reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No