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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07285980
Acronym
BBLP
Enrollment
180
Registered
2025-12-16
Start date
2025-03-01
Completion date
2025-07-31
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Propofol Injection Pain

Keywords

propofol, lidocaine, Bier block, Intravenous regional anesthesia, Anesthesia, intravenous, Pain, injection

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.

Interventions

DRUGpropofol

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

DRUGLidocaine - Propofol Mixture

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

DRUGLidocaine - Bier Block

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

Sponsors

Asma Ladib
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Both the participant and the investigator assessing pain were blinded to group allocation. The propofol syringes were prepared by an anesthesiologist not involved in data collection.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of pain during propofol injectionImmediate (within 30 seconds after propofol injection)Proportion of patients with any pain (score ≥1 on 4-point verbal rating scale).

Secondary

MeasureTime frameDescription
Severity of pain during propofol injectionImmediate (during propofol injection)Pain intensity on a 4-point verbal rating scale (0-3).
Change in mean arterial pressure after propofol injection1 minute after propofol injectionDifference in mean arterial pressure between baseline and 1 minute after propofol injection.
Change in heart rate after propofol injection1 minute after propofol injectionDifference in heart rate between baseline and 1 minute after propofol injection.
Local adverse effects at the injection siteWithin 10 minutes after propofol injectionPresence of erythema, edema, or venous irritation.

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026