Effects of Pretreatment with Different Doses of Lidocaine on Injection Pain

NCT06865300 | Completed DMC

• 1 other identifier: Mücahit
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

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.

Conditions

Rocuronium Adverse Reaction; Lidocaine Adverse Reaction

Keywords

rocuronium; lidocaine

Outcome Measures

Primary Outcomes (1)

• Visual analog score after the injection

  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.

  From enrollment to the end of injection at 5 minutes.

Secondary Outcomes (4)

• Changes on heart rate

  Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.

• 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.

• Changes on oxygen saturation

  Hemodynamic parameters were recorded 5 minutes intervals.

• Adverse effects

  Adverse effects of the drug were observed during 5 minutes after the injection.

Study Arms (3)

Injection of serum physiologic that contains no drug.

PLACEBO COMPARATOR

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

Drug: serum physiologic

40 mg lidocain group

EXPERIMENTAL

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.

Drug: Lidocain 40 mg

1 mg/kg lidocain group

EXPERIMENTAL

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.

Drug: lidocain 1 mg/kg

Interventions

Lidocain 40 mg DRUG

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

Also known as: Lidocain, 40 mg lidocain

40 mg lidocain group

lidocain 1 mg/kg DRUG

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

Also known as: lidocain, 1 mg/kg lidocain

1 mg/kg lidocain group

serum physiologic DRUG

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

Also known as: izotonic fluid

Injection of serum physiologic that contains no drug.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged between 18 and 65 with ASA I and II

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead

Study Sites (2)

Giresun University

Giresun, Turkey, Turkey (Türkiye)

Location

Giresun Training and Research Hospital

Giresun, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 18008122 BACKGROUND

• 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.

  PMID: 12594153 BACKGROUND

• 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.

  PMID: 26422874 BACKGROUND

• 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.

  PMID: 15781511 BACKGROUND

• 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.

  PMID: 10740559 BACKGROUND

Study Officials

• Azime Bulut

  Giresun University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in the Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: March 7, 2025
• Study Start: July 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)