Effects of Pretreatment with Different Doses of Lidocaine on Injection Pain

NCT ID: NCT06865300

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Rocuronium Adverse Reaction Lidocaine Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Injection of serum physiologic that contains no drug.

We injected serum physiologic that contains no drug before injection of rocuronium and recorded pain score.

Group Type PLACEBO_COMPARATOR

serum physiologic

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Lidocain 40 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

lidocain 1 mg/kg

Intervention Type DRUG

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

Interventions

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Lidocain 40 mg

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

Intervention Type DRUG

lidocain 1 mg/kg

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

Intervention Type DRUG

serum physiologic

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

Intervention Type DRUG

Other Intervention Names

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Lidocain 40 mg lidocain lidocain 1 mg/kg lidocain izotonic fluid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Giresun University

OTHER

Sponsor Role lead

Responsible Party

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Azime Bulut

Associate Professor in the Department of Anesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Azime Bulut

Role: STUDY_DIRECTOR

Giresun University

Locations

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Giresun University

Giresun, Turkey, Turkey (Türkiye)

Site Status

Giresun Training and Research Hospital

Giresun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 18008122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12594153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26422874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15781511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10740559 (View on PubMed)

Other Identifiers

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Mücahit

Identifier Type: -

Identifier Source: org_study_id

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