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Effect of Patient Awareness on Incidence and Severity of Propofol Injection Induced PainPhase 2No acronymNCT05886972

Effect Of Patient Awareness About Possibility Of Occurrence Of Pain During Propofol Injection On The Rate Of Incidence And Severity Of Pain During Injection .

A Phase 2 study testing Awareness about propofol injection induced pain in people with Effect of Patient Awareness on Incidence and Severity of Propofol Injection Induced Pain, run by Beni-Suef University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Propofol is the most common intravenous (IV) anesthetic agent, used for anesthesia induction and maintenance during surgeries due to its rapid onset and short duration. However, the incidence of propofol injection pain occurs in about 20% to 90% of patients that can decrease patient satisfaction and safety . Read more about this study

Who is it for?
Ages 20 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Awareness about propofol injection induced pain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteEgypt
Study dates
1 Jul 2023to 1 Nov 2023
Phase
Phase 2

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 20 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female patients aged 20 to 40 years of The American Society of Anesthesiologists (ASA) I-II , who will be undergoing elective surgery under general anesthesia

Who cannot join

  • patient with mental illness, poor understanding or difficulty in communication or pain assessment .
  • any organ dysfunction, neurological disease, diabetes mellitus .
  • patient with high education level (patient with education level after high secondary school) .
  • patient with Body Mass Index (BMI) < 18 or > 30
  • allergy to the study drugs .
  • history of chronic pain or those taking regular analgesics, anti-inflammatory drugs pre-operatively .
  • history of drug abuse and other contraindication for lidocaine such as severe bradycardia, Wolf-Parkinson-White syndrome, and other tachyarrhythmias .

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mahmoud Hussein Bahr

    Beni-suef, Cairo Governorate, 62521

Other trials in Egypt

About this study

Official title: Effect Of Patient Awareness About Possibility Of Occurrence Of Pain During Propofol Injection On The Rate Of Incidence And Severity Of Pain During Injection ; A Randomized Controlled Study.

Propofol is the most common intravenous (IV) anesthetic agent, used for anesthesia induction and maintenance during surgeries due to its rapid onset and short duration.

However, the incidence of propofol injection pain occurs in about 20% to 90% of patients that can decrease patient satisfaction and safety .

Awareness of patient about propofol injection pain can affect patient anxiety and stress that will be reflected on incidence and severity of occurance of propofol injection pain. In our study the effect of patient awareness on propofol injection pain will be evaluated after adequate using of the pharmacological and non-pharmacological therapy that have been demonstrated to be effective in attenuating injection pain.

Read the detailed description

Propofol is the most common intravenous (IV) anesthetic agent, used for anesthesia induction and maintenance during surgeries due to its rapid onset and short duration .

However, the incidence of propofol injection pain occurs in about 20% to 90% of patients that can decrease patient satisfaction and safety .

The mechanism of propofol injection pain has not been known yet, but many factors are involved that include the intrinsic drug property (e.g. emulsion composition, pH of the formulation, temperature, injection volume and osmolarity) .

As the lipid solvent irritates the venous intima and triggers a local kallikrein kinin cascade by discharging bradykinin and inflammatory factors, and injection pain occurs when peripheral nerve endings are directly exposed to propofol .

Other factors, including the site of injection, speed of injection, vein size, blood buffering, sex and simultaneous use of different drugs, seem to affect the incidence and severity of propofol injection pain .

The incidence and the severity of pain following propofol injection is increased in peripheral site of injection , smaller size of the vessels and slow injection and the pain can be reduced by rapid injection of propofol into the large sized veins as veins of antecubital fossa, however, this is not always practical in clinical practice .

Propofol injection pain is more common and more sever in females than males and the suggested reason of gender difference is due to the mechanical effect that male has a larger venous size than female while another factor suggested is the difference of pain sensitivity observed between the gender.

Low education level also increases the incidence and the severity of propofol injection pain as high education level will help during the patients' preoperative preparations and will reduce preoperative anxiety .

Psychogenic factors such as anxiety, depression, and fear of pain are frequently observed in patients undergoing elective surgery. Among these, preoperative anxiety and pain sensitivity has been the most important factors .

Preoperative anxiety activates the release of neuroendocrine mediators related to stress response and negatively affects anesthetic methods, surgical recovery, and postoperative pain levels .

Awareness of patient about propofol injection pain can affect patient anxiety and stress that will be reflected on incidence and severity of occurance of propofol injection pain. In our study the effect of patient awareness on propofol injection pain will be evaluated after adequate using of the pharmacological and non-pharmacological therapy that have been demonstrated to be effective in attenuating injection pain.

Many approaches have been recommended to decrease propofol injection pain including both pharmacological (e.g. pre-treatment with Paracetamol , lidocaine, magnesium sulfate, ketamine , ondansetron , Granisetron ,and and triglycerides ) .

It is generally approved that lidocaine is an adequate anesthetic that precludes injection pain. However, its adverse cardiovascular and hemodynamic effects and swelling at its injection site require to be further studied .

Being tested
Awareness about propofol injection induced pain
Keywords
Propofol injection induced pain, Patient awareness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Awareness about propofol injection induced painBehavioural

    The aim of the study is to observe the effect of patient awareness about the possibility of occurrence of pain during propofol injection on the rate of incidence and severity of pain during injection as a primary goal as the pain score of propofol injection pain is the main end point of the study .

Study groups in NCT05886972
Study groupRoleWhat they receive
Patients aware about propofol injection induced painActive comparatorPatients who will be informed about the possibility of incidence of propofol injection pain
Receives: Behavioral: Awareness about propofol injection induced pain
Patients not aware about propofol injection induced painActive comparatorPatients will not be informed about the possibility of incidence of propofol injection pain
Receives: Behavioral: Awareness about propofol injection induced pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain assessment

    Pain intensity will be measured by Verbal categorical scoring (VCS) Verbal categorical scoring (VCS) is a 4-point pain scale: 0-no pain, 1-mild pain with no behavioral sign, 2-moderate pain accompanied by a behavioral sign, and 3-severe pain with a strong vocal response accompanied by facial grimacing, arm withdrawal, or crying ( Jeon Y ,2012).

    Measured: During first 10 seconds after receiving first dose of propofol

Secondary outcomes (2)
  1. Age

    Age per years

    Measured: Preoperative visit

  2. Weight

    Weight by kilograms

    Measured: Preoperative visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start1 Jul 2023
  3. Primary completion1 Oct 2023
  4. Study completion1 Nov 2023

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 groups One informed about possibilities of pain with injection Other group not informed
Masking
Single blind
Who is masked
Participant
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05886972
Sponsor's protocol ID
FMBSUREC/02052023/sayem
Acronym
No acronym
Status last verified
Jul 2026
First submitted
24 May 2023
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Not decided yet

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