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

NCT07285980 | Completed

• 1 other identifier: BBLP2024
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Propofol Injection Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of pain during propofol injection

  Proportion of patients with any pain (score ≥1 on 4-point verbal rating scale).

  Immediate (within 30 seconds after propofol injection)

Secondary Outcomes (4)

• Severity of pain during propofol injection

  Immediate (during propofol injection)

• Change in mean arterial pressure after propofol injection

  1 minute after propofol injection

• Change in heart rate after propofol injection

  1 minute after propofol injection

• Local adverse effects at the injection site

  Within 10 minutes after propofol injection

Study Arms (3)

Control Group - Propofol alone

ACTIVE COMPARATOR

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.

Drug: propofol

Lidocaine-Propofol Mixture Group

EXPERIMENTAL

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.

Drug: Lidocaine - Propofol Mixture

Bier Block Group - Intravenous Lidocaine under Venous Occlusion

EXPERIMENTAL

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.

Drug: Lidocaine - Bier Block

Interventions

propofol DRUG

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

Also known as: Diprivan

Control Group - Propofol alone

Lidocaine - Propofol Mixture DRUG

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

Also known as: Xylocaine-Propofol mixture

Lidocaine-Propofol Mixture Group

Lidocaine - Bier Block DRUG

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

Also known as: Intravenous regional anesthesia with lidocaine

Bier Block Group - Intravenous Lidocaine under Venous Occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asma Ladib: lead

Study Sites (1)

Maternity and Neonatology Center of Monastir

Monastir, Monastir Governorate, 5000, Tunisia

Location

MeSH Terms

Conditions

Pain

Interventions

Propofol; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Asma Ladib, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Critical Care

Model Details: Three-arm parallel, randomized, double-blind clinical trial comparing the preventive efficacy of Bier block and lidocaine-propofol mixture on propofol injection pain.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 16, 2025
• Study Start: March 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication, for 5 years
• Access Criteria: Researchers with sound proposals may request anonymized data from Dr Asma Ladib for academic, non-commercial use

Locations

TU (1)