Comparison of Bier Block and a Lidocaine-Propofol Mixture for the Prevention of Propofol Injection Pain: A Randomized, Double-Blind Clinical Trial

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.