Clinical trial NCT06865300: Effects of Pretreatment with Different Doses of Lidocaine on Injection Pain
Official title: Effects of Pretreatment with Different Doses of Lidocaine on Injection Pain and Rocuronium-induced Withdrawal Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rocuronium Adverse Reaction
Lidocaine Adverse Reaction
Keywords: rocuronium
lidocaine
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analog score after the injection
timeFrame: From enrollment to the end of injection at 5 minutes.
Secondary outcomes:
measure: Changes on heart rate
timeFrame: Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.
measure: Changes on noninvasive blood pressure
timeFrame: Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.
measure: Changes on oxygen saturation
timeFrame: Hemodynamic parameters were recorded 5 minutes intervals.
measure: Adverse effects
timeFrame: Adverse effects of the drug were observed during 5 minutes after the injection.
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun Training and Research Hospital
city: Giresun
country: Turkey
facility: Giresun University
Study officials:
affiliation: Giresun University
name: Azime Bulut
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.