Maternity and Neonatology Center of Monastir
Monastir, Monastir Governorate, 5000, Tunisia
NCT Number: NCT07285980
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Monastir, Monastir Governorate, 5000, Tunisia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous anesthetic used for induction of anesthesia at a dose of 2 mg/kg.
Other names: Diprivan
40 mg lidocaine mixed directly with propofol prior to intravenous injection to reduce injection pain.
Other names: Xylocaine-Propofol mixture
40 mg lidocaine injected intravenously under venous occlusion for 2 minutes before propofol administration.
Other names: Intravenous regional anesthesia with lidocaine
Time frame: Immediate (within 30 seconds after propofol injection)
Proportion of patients with any pain (score ≥1 on 4-point verbal rating scale).
Time frame: Immediate (during propofol injection)
Pain intensity on a 4-point verbal rating scale (0-3).
Time frame: 1 minute after propofol injection
Difference in mean arterial pressure between baseline and 1 minute after propofol injection.
Time frame: 1 minute after propofol injection
Difference in heart rate between baseline and 1 minute after propofol injection.
Time frame: Within 10 minutes after propofol injection
Presence of erythema, edema, or venous irritation.
Asma Ladib
Other
Comparison of Bier Block and a Lidocaine-Propofol Mixture for the Prevention of Propofol Injection Pain: A Randomized, Double-Blind Clinical Trial
Acronym: BBLP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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