Clinical trial NCT06643832: Modulation of Propofol Injection Pain by Rubbing and Distraction
Official title: Spinal and Supra-spinal Modulation of Propofol Injection Pain by Rubbing and Distraction: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Propofol Injection
Pain
Rubbing
Distraction
Keywords: Pain, Modulation
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of propofol injection pain
timeFrame: Pain will be evaluated every 5 seconds during the propofol injection until loss of concioussness. The highest pain score will be recorded
Secondary outcomes:
measure: Degree of pain
timeFrame: every 5 seconds during injection and the highest value will be recorded.
measure: Recall of pain
timeFrame: 1 hour after surgery
measure: adverse effects
timeFrame: 1 hour after surgery
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbia
Study officials:
References: