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Completed

NCT Number: NCT06865300

Effects of Pretreatment With Different Doses of Lidocaine on Injection Pain

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.

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Key information

Conditions

Rocuronium Adverse Reaction Lidocaine Adverse Reaction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Giresun University, Giresun, Turkey, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocain 40 mg

Drug

We injected 40 mg lidocain before rocuronium injection. Then we recorded pain score by using visual analog scale.

Other names: Lidocain, 40 mg lidocain

lidocain 1 mg/kg

Drug

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

serum physiologic

Drug

We injected serum physiologic before rocuronium injection. Then we recorded pain score by using visual analog scale.

Other names: izotonic fluid

Primary outcomes

  1. Visual analog score after the injection

    Time frame: 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 outcomes

  1. Changes on heart rate

    Time frame: 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.

  2. Changes on noninvasive blood pressure

    Time frame: 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.

  3. Changes on oxygen saturation

    Time frame: 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.

  4. Adverse effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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