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

NCT ID: NCT07285980

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-07-31

Brief 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.

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.

Conditions

Propofol Injection Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Control Group - Propofol alone

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.

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

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

Lidocaine-Propofol Mixture Group

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.

Group Type: EXPERIMENTAL

Lidocaine - Propofol Mixture

Intervention Type: DRUG

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

Bier Block Group - Intravenous Lidocaine under Venous Occlusion

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.

Group Type: EXPERIMENTAL

Lidocaine - Bier Block

Intervention Type: DRUG

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

Interventions

propofol

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

Intervention Type: DRUG

Lidocaine - Propofol Mixture

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

Intervention Type: DRUG

Lidocaine - Bier Block

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

Intervention Type: DRUG

Other Intervention Names

Diprivan; Xylocaine-Propofol mixture; Intravenous regional anesthesia with lidocaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asma Ladib

OTHER

Sponsor Role: lead

Responsible Party

Asma Ladib

Assistant Professor of Anesthesiology and Critical Care

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Asma Ladib, MD

Role: PRINCIPAL_INVESTIGATOR

Maternity and Neonatology Center of Monastir, Dept of Anesthesiology and Critical Care B

Locations

Maternity and Neonatology Center of Monastir

Monastir, Monastir Governorate, Tunisia

Countries

Tunisia

Other Identifiers

BBLP2024

Identifier Type: -

Identifier Source: org_study_id