Modulation of Propofol Injection Pain by Rubbing and Distraction

NCT06643832 | Completed

• 1 other identifier: 36264PR878/9/24
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Propofol Injection; Pain; Rubbing; Distraction

Keywords

Pain, Modulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Degree of pain

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

• Recall of pain

  1 hour after surgery

• adverse effects

  1 hour after surgery

Study Arms (3)

Rubbing Distraction group

EXPERIMENTAL

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

Lidocaine group

ACTIVE COMPARATOR

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

Drug: Lidocaine (drug)

Saline group

PLACEBO COMPARATOR

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

Interventions

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.

Rubbing Distraction group

Lidocaine (drug) DRUG

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

Lidocaine group

Saline OTHER

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

Saline group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Pharmaceutical Preparations; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: open label for rubbing distraction group which is the novel approach to be tested in this trial (obviously, participant and pain assessor in the rubbing distraction group can not be blinded). however, lidocaine group and control group patients and their pain assessors are blinded to group assignment. so a final description of (partially blinded study) can be adopted.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesiology, surgical Intensive care and pain medicine

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: October 16, 2024
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: February 18, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study
• Access Criteria: The data will be available upon reasonable request from the corresponding author

Locations

EG (1)