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Completed

NCT Number: NCT07285980

Comparison of Bier Block and Lidocaine-Propofol Mixture for Prevention of Propofol Injection Pain

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternity and Neonatology Center of Monastir

Monastir, Monastir Governorate, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Propofol

Drug

Intravenous anesthetic used for induction of anesthesia at a dose of 2 mg/kg.

Other names: Diprivan

Lidocaine - Propofol Mixture

Drug

40 mg lidocaine mixed directly with propofol prior to intravenous injection to reduce injection pain.

Other names: Xylocaine-Propofol mixture

Lidocaine - Bier Block

Drug

40 mg lidocaine injected intravenously under venous occlusion for 2 minutes before propofol administration.

Other names: Intravenous regional anesthesia with lidocaine

Primary outcomes

  1. 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).

Secondary outcomes

  1. Severity of pain during propofol injection

    Time frame: Immediate (during propofol injection)

    Pain intensity on a 4-point verbal rating scale (0-3).

  2. Change in mean arterial pressure after propofol injection

    Time frame: 1 minute after propofol injection

    Difference in mean arterial pressure between baseline and 1 minute after propofol injection.

  3. Change in heart rate after propofol injection

    Time frame: 1 minute after propofol injection

    Difference in heart rate between baseline and 1 minute after propofol injection.

  4. Local adverse effects at the injection site

    Time frame: Within 10 minutes after propofol injection

    Presence of erythema, edema, or venous irritation.

Sponsors and collaborators

Lead sponsor

Asma Ladib

Other

Registry information

Official study title

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

Acronym: BBLP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2025
Registry last updated
Dec 26, 2025

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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