Propofol InjectionNCT06643832
Modulation of Propofol Injection Pain by Rubbing and Distraction
A study testing Rubbing Distraction, Lidocaine (drug) and Saline in people with Propofol Injection and Pain, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Propofol Injection, Pain, Rubbing
- What is being tested?
- Rubbing Distraction, Lidocaine (drug) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Oct 2024to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Rubbing Distraction, Lidocaine (drug), Saline
- Keywords
- Pain, Modulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubbing DistractionOther
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 (drug)Drug
lidocaine will be used by mixing it with the propofol before intravenous injection
SalineOther
intravenous propofol will be given without mixing with any drug (except for 2 ml saline to ensure blindness of the outcome assessor).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Rubbing Distraction |
| Lidocaine group | Active comparator | patients will receive intravenous propofol mixed with 2ml of lidocaine 2% (40mg) before injection. Receives: 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). Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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)
Measured: 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
Measured: 1 hour after surgery
adverse effects
Like redness or edema will be examined at the site of propofol injection
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start16 Oct 2024
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol InjectionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643832
- Sponsor's protocol ID
- 36264PR878/9/24
- Status last verified
- Sep 2024
- First submitted
- 14 Oct 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal and Supra-spinal Modulation of Propofol Injection Pain by Rubbing and Distraction: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06643832
- Acronym / sponsor ID
- 36264PR878/9/24
- Conditions
- Propofol Injection, Pain, Rubbing, Distraction
- Keywords
- Pain, Modulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rubbing Distraction group | Experimental | Other: Rubbing Distractionrubbing 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. |
| Lidocaine group | Active comparator | Drug: Lidocaine (drug)patients will receive intravenous propofol mixed with 2ml of lidocaine 2% (40mg) before injection. |
| Saline group | Placebo comparator | Other: Salinepatients will receive intravenous propofol not mixed with any drug (except for 2 ml of saline to ensure blindness of the outcome assessor). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rubbing Distractiongently 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. | Other | Rubbing Distraction group |
| Lidocaine (drug)lidocaine will be used by mixing it with the propofol before intravenous injection | Drug | Lidocaine group |
| Salineintravenous propofol will be given without mixing with any drug (except for 2 ml saline to ensure blindness of the outcome assessor). | Other | Saline group |
Primary outcome
Incidence of propofol injection pain
Time frame: Pain will be evaluated every 5 seconds during the propofol injection until loss of concioussness. The highest pain score will be recorded
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).
3 secondary outcomes
Degree of pain
Time frame: every 5 seconds during injection and the highest value will be recorded.
Recall of pain
Time frame: 1 hour after surgery
adverse effects
Time frame: 1 hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author
Related trials for Propofol Injection
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A Novel Two-Step Dosing Induction Strategy (The Propofol Challenge Test) to Minimize Propofol Injection Pain
Any Patient Under General Anesthesia With Propofol Induction
Not yet recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
Healthy Volunteers
Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rubbing Distraction, Lidocaine (drug) and Saline in people with Propofol Injection and Pain, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of propofol injection pain (time frame: Pain will be evaluated every 5 seconds during the propofol injection until loss of concioussness. The highest pain score will be recorded). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.