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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06865300
Enrollment
210
Registered
2025-03-07
Start date
2023-07-01
Completion date
2023-12-31
Last updated
2025-03-07

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

Conditions

Rocuronium Adverse Reaction, Lidocaine Adverse Reaction

Keywords

rocuronium, lidocaine

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.

Interventions

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

DRUGlidocain 1 mg/kg

We injected 1 mg/kg lidocain before rocuronium injection. Then we recorded pain score by using visual analog scale.

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

Sponsors

Giresun University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analog score after the injectionFrom 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

MeasureTime frameDescription
Changes on heart rateHemodynamic 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 pressureHemodynamic 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 saturationHemodynamic 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 effectsAdverse 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

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