Propofol Injection PainBBLPNCT07285980
Comparison of Bier Block and Lidocaine-Propofol Mixture for Prevention of Propofol Injection Pain
A study testing propofol, Lidocaine - Propofol Mixture and Lidocaine - Bier Block in people with Propofol Injection Pain, run by Asma Ladib at 1 site in Tunisia.
Trial summary
The goal of this clinical trial was to evaluate methods to prevent pain on intravenous administration of propofol during induction of anesthesia. Propofol frequently causes a burning or painful sensation when injected into a peripheral vein. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Propofol Injection Pain
- What is being tested?
- propofol, Lidocaine - Propofol Mixture and Lidocaine - Bier Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2025to 31 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older
- American Society of Anesthesiologists (ASA) physical status I to III
- Scheduled for elective surgery under general anesthesia requiring intravenous induction with propofol
Who cannot join
- Patient refusal
- Known hypersensitivity to local anesthetics or propofol
- Pre-existing vascular disease
- Infection at the intended injection site
- Chronic use of analgesics or anxiolytics
- Inability to understand the pain assessment scale
- History of drug abuse
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Maternity and Neonatology Center of Monastir
Monastir, Monastir Governorate, 5000
About this study
Official title: Comparison of Bier Block and a Lidocaine-Propofol Mixture for the Prevention of Propofol Injection Pain: A Randomized, Double-Blind Clinical Trial
The goal of this clinical trial was to evaluate methods to prevent pain on intravenous administration of propofol during induction of anesthesia. Propofol frequently causes a burning or painful sensation when injected into a peripheral vein.
This randomized study compared three approaches in adult patients scheduled for elective surgery: propofol alone (control), propofol with 40 mg lidocaine mixed directly, and a brief intravenous lidocaine under venous occlusion (Bier block) using 40 mg for 2 minutes before propofol.
The primary outcome was the incidence of pain on propofol injection measured with a 4-point verbal rating scale (0 = no pain to 3 = severe pain). Secondary outcomes included pain intensity, peri-induction hemodynamic parameters, and local injection-site adverse effects.
Read the detailed description
Study Design and Setting This study was designed as a prospective, single-center, randomized, double-blind, parallel-group clinical trial conducted at the Maternity and Neonatology Center of Monastir (Tunisia). The trial was carried out between March 2025 and July 2025 in accordance with institutional standards for general anesthesia.
Study Procedures Upon arrival in the operating room, standard monitoring was applied, including non-invasive blood pressure, electrocardiography, and pulse oximetry. A peripheral intravenous catheter was inserted in a vein of the upper limb used for propofol administration. No analgesic or sedative premedication was administered prior to induction.
Patients were allocated to one of three study groups according to a predefined randomization sequence. All study drugs were administered through the same intravenous access under standardized conditions.
In the control group, propofol was administered intravenously without lidocaine pretreatment. In the lidocaine-propofol mixture group, lidocaine was added directly to the propofol syringe immediately before injection. In the Bier block group, lidocaine was administered intravenously under venous occlusion using a tourniquet applied proximally for a short, predefined duration, followed by release of the tourniquet and intravenous administration of propofol.
Randomization and Blinding Randomization was performed using a block randomization method. Study syringes were prepared by an anesthesiologist not involved in patient management or outcome assessment. Patients, anesthesia providers, investigators, and outcome assessors remained blinded to group allocation throughout the study.
Data Collection and Monitoring Pain during propofol injection was assessed immediately at the time of administration by an independent observer using a standardized verbal rating scale. Hemodynamic parameters were recorded at predefined time points during induction of anesthesia. Patients were monitored for local adverse effects at the injection site following propofol administration.
Ethical Considerations The study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval was obtained prior to study initiation, and written informed consent was obtained from all participants before enrollment.
- Conditions
- Propofol Injection Pain
- Being tested
- propofol, Lidocaine - Propofol Mixture, Lidocaine - Bier Block
- Keywords
- propofol, lidocaine, Bier block, Intravenous regional anesthesia, Anesthesia, intravenous, Pain, injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called Diprivan
Intravenous anesthetic used for induction of anesthesia at a dose of 2 mg/kg.
Lidocaine - Propofol MixtureDrug
Also called Xylocaine-Propofol mixture
40 mg lidocaine mixed directly with propofol prior to intravenous injection to reduce injection pain.
Lidocaine - Bier BlockDrug
Also called Intravenous regional anesthesia with lidocaine
40 mg lidocaine injected intravenously under venous occlusion for 2 minutes before propofol administration.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - Propofol alone | Active comparator | Patients in this control arm received intravenous propofol at a dose of 2 mg/kg without any lidocaine pretreatment. Pain during propofol injection was evaluated, and results were used as the reference comparator for the two active investigational interventions. Receives: Drug: propofol |
| Lidocaine-Propofol Mixture Group | Experimental | Patients in this experimental arm received a mixture prepared by adding 40 mg of lidocaine directly into the propofol syringe immediately before intravenous administration. The total dose of propofol administered was 2 mg/kg. This intervention was evaluated relative to the control arm for its ability to reduce injection-related discomfort. Receives: Drug: Lidocaine - Propofol Mixture |
| Bier Block Group - Intravenous Lidocaine under Venous Occlusion | Experimental | Patients in this experimental arm received 40 mg of intravenous lidocaine administered under venous occlusion using a Bier block technique for approximately 2 minutes. After release of the tourniquet, propofol was administered intravenously at a dose of 2 mg/kg. This intervention was evaluated for its ability to reduce discomfort associated with propofol injection. Receives: Drug: Lidocaine - Bier Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pain during propofol injection
Proportion of patients with any pain (score ≥1 on 4-point verbal rating scale).
Measured: Immediate (within 30 seconds after propofol injection)
Secondary outcomes (4)
Severity of pain during propofol injection
Pain intensity on a 4-point verbal rating scale (0-3).
Measured: Immediate (during propofol injection)
Change in mean arterial pressure after propofol injection
Difference in mean arterial pressure between baseline and 1 minute after propofol injection.
Measured: 1 minute after propofol injection
Change in heart rate after propofol injection
Difference in heart rate between baseline and 1 minute after propofol injection.
Measured: 1 minute after propofol injection
Local adverse effects at the injection site
Presence of erythema, edema, or venous irritation.
Measured: Within 10 minutes after propofol injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Mar 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol Injection PainStudies of the same condition, open and under way.
- 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
- Model description
- Three-arm parallel, randomized, double-blind clinical trial comparing the preventive efficacy of Bier block and lidocaine-propofol mixture on propofol injection pain.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asma Ladib
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asma Ladib, University of Monastir
- Investigators
- Asma Ladib, MD, Principal investigator, Maternity and Neonatology Center of Monastir, Dept of Anesthesiology and Critical Care B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285980
- Sponsor's protocol ID
- BBLP2024
- Acronym
- BBLP
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (de-identified) that underlie the results reported in this article will be made available upon reasonable request to the principal investigator (Dr Asma Ladib, asmaladib@yahoo.com) after publication, for researchers who provide a methodologically sound proposal. Data will be available in an anonymized format for academic and non-commercial use.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bier Block and a Lidocaine-Propofol Mixture for the Prevention of Propofol Injection Pain: A Randomized, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07285980
- Acronym / sponsor ID
- BBLP / BBLP2024
- Conditions
- Propofol Injection Pain
- Keywords
- propofol, lidocaine, Bier block, Intravenous regional anesthesia, Anesthesia, intravenous, Pain, injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Asma LadibUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 16 Dec 2025 (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.
The goal of this clinical trial was to evaluate methods to prevent pain on intravenous administration of propofol during induction of anesthesia. Propofol frequently causes a burning or painful sensation when injected into a peripheral vein.
This randomized study compared three approaches in adult patients scheduled for elective surgery: propofol alone (control), propofol with 40 mg lidocaine mixed directly, and a brief intravenous lidocaine under venous occlusion (Bier block) using 40 mg for 2 minutes before propofol.
The primary outcome was the incidence of pain on propofol injection measured with a 4-point verbal rating scale (0 = no pain to 3 = severe pain). Secondary outcomes included pain intensity, peri-induction hemodynamic parameters, and local injection-site adverse effects.
Detailed description
Study Design and Setting This study was designed as a prospective, single-center, randomized, double-blind, parallel-group clinical trial conducted at the Maternity and Neonatology Center of Monastir (Tunisia). The trial was carried out between March 2025 and July 2025 in accordance with institutional standards for general anesthesia.
Study Procedures Upon arrival in the operating room, standard monitoring was applied, including non-invasive blood pressure, electrocardiography, and pulse oximetry. A peripheral intravenous catheter was inserted in a vein of the upper limb used for propofol administration. No analgesic or sedative premedication was administered prior to induction.
Patients were allocated to one of three study groups according to a predefined randomization sequence. All study drugs were administered through the same intravenous access under standardized conditions.
In the control group, propofol was administered intravenously without lidocaine pretreatment. In the lidocaine-propofol mixture group, lidocaine was added directly to the propofol syringe immediately before injection. In the Bier block group, lidocaine was administered intravenously under venous occlusion using a tourniquet applied proximally for a short, predefined duration, followed by release of the tourniquet and intravenous administration of propofol.
Randomization and Blinding Randomization was performed using a block randomization method. Study syringes were prepared by an anesthesiologist not involved in patient management or outcome assessment. Patients, anesthesia providers, investigators, and outcome assessors remained blinded to group allocation throughout the study.
Data Collection and Monitoring Pain during propofol injection was assessed immediately at the time of administration by an independent observer using a standardized verbal rating scale. Hemodynamic parameters were recorded at predefined time points during induction of anesthesia. Patients were monitored for local adverse effects at the injection site following propofol administration.
Ethical Considerations The study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval was obtained prior to study initiation, and written informed consent was obtained from all participants before enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel, randomized, double-blind clinical trial comparing the preventive efficacy of Bier block and lidocaine-propofol mixture on propofol injection pain.
| Arm | Type | Receives |
|---|---|---|
| Control Group - Propofol alone | Active comparator | Drug: propofolPatients in this control arm received intravenous propofol at a dose of 2 mg/kg without any lidocaine pretreatment. Pain during propofol injection was evaluated, and results were used as the reference comparator for the two active investigational interventions. |
| Lidocaine-Propofol Mixture Group | Experimental | Drug: Lidocaine - Propofol MixturePatients in this experimental arm received a mixture prepared by adding 40 mg of lidocaine directly into the propofol syringe immediately before intravenous administration. The total dose of propofol administered was 2 mg/kg. This intervention was evaluated relative to the control arm for its ability to reduce injection-related discomfort. |
| Bier Block Group - Intravenous Lidocaine under Venous Occlusion | Experimental | Drug: Lidocaine - Bier BlockPatients in this experimental arm received 40 mg of intravenous lidocaine administered under venous occlusion using a Bier block technique for approximately 2 minutes. After release of the tourniquet, propofol was administered intravenously at a dose of 2 mg/kg. This intervention was evaluated for its ability to reduce discomfort associated with propofol injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 years or older
- American Society of Anesthesiologists (ASA) physical status I to III
- Scheduled for elective surgery under general anesthesia requiring intravenous induction with propofol
Key exclusion criteria (7 listed)
- Patient refusal
- Known hypersensitivity to local anesthetics or propofol
- Pre-existing vascular disease
- Infection at the intended injection site
- Chronic use of analgesics or anxiolytics
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 |
|---|---|---|
| propofolAlso: DiprivanIntravenous anesthetic used for induction of anesthesia at a dose of 2 mg/kg. | Drug | Control Group - Propofol alone |
| Lidocaine - Propofol MixtureAlso: Xylocaine-Propofol mixture40 mg lidocaine mixed directly with propofol prior to intravenous injection to reduce injection pain. | Drug | Lidocaine-Propofol Mixture Group |
| Lidocaine - Bier BlockAlso: Intravenous regional anesthesia with lidocaine40 mg lidocaine injected intravenously under venous occlusion for 2 minutes before propofol administration. | Drug | Bier Block Group - Intravenous Lidocaine under Venous Occlusion |
Primary outcome
Incidence of pain during propofol injection
Time frame: Immediate (within 30 seconds after propofol injection)
Proportion of patients with any pain (score ≥1 on 4-point verbal rating scale).
4 secondary outcomes
Severity of pain during propofol injection
Time frame: Immediate (during propofol injection)
Change in mean arterial pressure after propofol injection
Time frame: 1 minute after propofol injection
Change in heart rate after propofol injection
Time frame: 1 minute after propofol injection
Local adverse effects at the injection site
Time frame: Within 10 minutes after propofol injection
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 26 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (de-identified) that underlie the results reported in this article will be made available upon reasonable request to the principal investigator (Dr Asma Ladib, asmaladib@yahoo.com) after publication, for researchers who provide a methodologically sound proposal. Data will be available in an anonymized format for academic and non-commercial use.
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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.
Asma Ladib, MD principal investigator
Maternity and Neonatology Center of Monastir, Dept of Anesthesiology and Critical Care B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol, Lidocaine - Propofol Mixture and Lidocaine - Bier Block in people with Propofol Injection Pain, run by Asma Ladib at 1 site in Tunisia.
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 3 inclusion and 7 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 26 Dec 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 Tunisia. 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. 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 pain during propofol injection (time frame: Immediate (within 30 seconds after propofol injection)). 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 26 Dec 2025.