Effects of Pretreatment with Different Doses of Lidocaine on Injection Pain

Effects of Pretreatment with Different Doses of Lidocaine on Injection Pain and Rocuronium-induced Withdrawal Response

One of the medications administered to patients in general anesthesia practice is rocuronium, which causes pain during intravenous administration. It is known that a drug containing lidocaine as the active ingredient can reduce the pain caused by rocuronium in different doses. The effective dose of lidocaine remains a topic of debate. In our study, we aimed to investigate the efficacy of two different doses of lidocaine. No adverse effects are expected from this medication.

Study Overview

• Status: Completed
• Conditions: Lidocaine Adverse Reaction; Rocuronium Adverse Reaction
• Intervention / Treatment: Drug: serum physiologic; Drug: Lidocain 40 mg; Drug: lidocain 1 mg/kg

Detailed Description

The patients were randomly divided into three groups by a simple drawing-lots method: control group (Group C), 40 mg lidocaine group (Group L) and 1 mg/kg lidocaine group (Group L1). All patients were taken to the operating room without premedication and standard monitoring was applied. A 20 G intravenous catheter was inserted on the dorsum of the patients' non-dominant hand, and 100 ml/hour of physiological saline solution was infused over a 5-minute period. After randomization, 5 ml of isotonic solution was administered to the control group, 40 mg of lidocaine to the L group, and 1 mg kg-1 of lidocaine intravenously to the L1 group. Patients were administered 0.06 mg/kg of rocuronium, and they were asked, "Do you feel any pain or discomfort in your arm?" The pain intensity expressed by the patient was evaluated and recorded using the 5-point pain scale. After induction and intubation, the patients' blood pressure, pulse, and saturation values were recorded.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Giresun, Turkey
    • Giresun University
  • Giresun, Turkey
    • Giresun Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients aged between 18 and 65 with ASA I and II

Exclusion Criteria:

• Chronic sedative anxiolytic use
• Those with ASA III and higher
• Patients under 18 and over 65 years of age
• Those with severe COPD, asthma, or reactive airway disease
• Patients with a history of neuropsychiatric or neurological diseases
• Those with infections on the back of the hand
• Pregnant women
• Patients who will undergo rapid induction
• Patients with liver and kidney dysfunction
• Those with a history of thrombophlebitis
• Patients with muscle diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Injection of serum physiologic that contains no drug.; We injected serum physiologic that contains no drug before injection of rocuronium and recorded pain score.	Drug: serum physiologic; We injected serum physiologic before rocuronium injection. Then we recorded pain score by using visual analog scale.; Other Names: izotonic fluid
Experimental: 40 mg lidocain group; We injected 40 mg lidocain for the prevention of injection pain caused by rocuronium. We injected 0.06 mg/kg rocurunium and recorded pain by using visual analog scale.	Drug: Lidocain 40 mg; We injected 40 mg lidocain before rocuronium injection. Then we recorded pain score by using visual analog scale.; Other Names: Lidocain; 40 mg lidocain
Experimental: 1 mg/kg lidocain group; We injected 1 mg/kg lidocain for the prevention of injection pain caused by rocuronium. We injected 0.06 mg/kg rocurunium and recorded pain score by using visual analog scale.	Drug: lidocain 1 mg/kg; We injected 1 mg/kg lidocain before rocuronium injection. Then we recorded pain score by using visual analog scale.; Other Names: lidocain; 1 mg/kg lidocain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog score after the injection	We described Visual analog scale to the patient before the day of surgery. On the visual analog scale, a score of 10 is the worst pain in life, while a score of 0 is no pain. The patient is asked to give a score to his pain caused by rocuronium injection and the score is recorded.	From enrollment to the end of injection at 5 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on heart rate	All patients who will receive general anesthesia are routinely monitored with electrocardiogram, noninvazive blood pressure and oxygen saturation. We recorded heart rate as beat per minute before and after the injections during 20 minutes.	Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.
Changes on noninvasive blood pressure	All patients who will receive general anesthesia are routinely monitored with electrocardiogram, noninvazive blood pressure and oxygen saturation. We recorded noninvasive blood pressure as mmHg before and after the injections during 20 minutes.	Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.
Changes on oxygen saturation	All patients who will receive general anesthesia are routinely monitored with electrocardiogram, noninvazive blood pressure and oxygen saturation. We recorded oxygen saturation as percentage before and after the injections during 20 minutes.	Hemodynamic parameters were recorded 5 minutes intervals.
Adverse effects	After the injection of the drug we observed any side effect such as metallic taste, erythema, swelling, itching, allergic reaction.	Adverse effects of the drug were observed during 5 minutes after the injection.

Collaborators and Investigators

• Sponsor: Giresun University
• Investigators: Study Director: Azime Bulut, Giresun University

Publications and helpful links

General Publications

• Singh M, Chauhan H, Rath GP, Prabhakar H, Bithal PK, Dash HH. Effect of narcotic pretreatment on pain after rocuronium injection: a randomized, double-blind controlled comparison with lidocaine. J Anesth. 2007;21(4):510-2. doi: 10.1007/s00540-007-0560-8. Epub 2007 Nov 1.
• Chiarella AB, Jolly DT, Huston CM, Clanachan AS. Comparison of four strategies to reduce the pain associated with intravenous administration of rocuronium. Br J Anaesth. 2003 Mar;90(3):377-9. doi: 10.1093/bja/aeg054.
• Ergil J, Kavak Akelma F, Ozkan D, Bumin Aydin G, Gurel A, Akinci M. Effects of pretreatment with esmolol and lidocaine on injection pain and rocuronium-induced withdrawal response. Turk J Med Sci. 2015;45(4):959-63. doi: 10.3906/sag-1311-79.
• Ahmad N, Choy CY, Aris EA, Balan S. Preventing the withdrawal response associated with rocuronium injection: a comparison of fentanyl with lidocaine. Anesth Analg. 2005 Apr;100(4):987-990. doi: 10.1213/01.ANE.0000147790.76114.3A.
• Cheong KF, Wong WH. Pain on injection of rocuronium: influence of two doses of lidocaine pretreatment. Br J Anaesth. 2000 Jan;84(1):106-7. doi: 10.1093/oxfordjournals.bja.a013364.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 9, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: lidocaine; rocuronium
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: Mücahit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No