Effects of Pretreatment with Different Doses of Lidocaine on Injection Pain

Not Applicable

Completed

• Conditions: Rocuronium Adverse Reaction; Lidocaine Adverse Reaction
• Interventions: Drug: serum physiologic; Drug: Lidocain 40 mg; Drug: lidocain 1 mg/kg

• Registration Number: NCT06865300
• Lead Sponsor: Giresun University

Brief Summary

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.

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 Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31
• Study First Submitted: 2025-02-09
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection of serum physiologic that contains no drug.	serum physiologic	We injected serum physiologic that contains no drug before injection of rocuronium and recorded pain score.
40 mg lidocain group	Lidocain 40 mg	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.
1 mg/kg lidocain group	lidocain 1 mg/kg	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.

Primary Outcome Measures

Name	Time	Method
Visual analog score after the injection	From enrollment to the end of injection at 5 minutes.	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.

Secondary Outcome Measures

Name	Time	Method
Changes on heart rate	Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.	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.
Changes on noninvasive blood pressure	Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.	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.
Changes on oxygen saturation	Hemodynamic parameters were recorded 5 minutes intervals.	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.
Adverse effects	Adverse effects of the drug were observed during 5 minutes after the injection.	After the injection of the drug we observed any side effect such as metallic taste, erythema, swelling, itching, allergic reaction.

Trial Locations

Locations (2)

Giresun Training and Research Hospital; 🇹🇷 Giresun, Turkey

Giresun University; 🇹🇷 Giresun, Turkey