The Effect of Local Anesthetic Techniques on Hemodynamic Response and Postoperative Sore Throat in Double-Lumen Tubes

The Effect of Two Different Local Anesthetic Techniques on Hemodynamic Response and Postoperative Sore Throat in Patients Intubated with Double-Lumen Tubes: a Randomized Controlled Study

This clinical trial aims to determine if different local anesthetic application techniques can reduce postoperative sore throat (POST) and manage hemodynamic responses in adult patients undergoing elective thoracic surgery with double-lumen intubation. The main questions it aims to answer are:

• Does inhaled lidocaine or lidocaine applied to the double-lumen tube reduce the incidence and severity of POST?
• How do these anesthetic techniques impact hemodynamic stability during surgery?

Researchers will compare three groups-those receiving inhaled lidocaine, lidocaine applied to the tube, and a saline control group-to see if these methods differ in effectiveness.

Participants will:

• Undergo standard preoperative assessment and provide informed consent
• Be randomly assigned to receive either inhaled lidocaine, lidocaine applied to the tube, or saline
• Have sore throat scores and hemodynamic data recorded at specific intervals after surgery

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Sore Throat; Intubation, Intratracheal; Lidocaine Spray; Double-lumen Tube
• Intervention / Treatment: Drug: Tracheo-Spray; Drug: Lidocaine Spray on DLT; Drug: Saline (Placebo)

Detailed Description

This clinical trial is designed to evaluate the effects of two local anesthetic techniques on postoperative sore throat (POST) incidence and hemodynamic responses in patients undergoing elective thoracic surgery with double-lumen tube (DLT) intubation. POST is a common and undesirable outcome following general anesthesia with endotracheal intubation, particularly with DLTs due to their size and dual cuffs, which can increase mucosal irritation. Addressing POST effectively could significantly improve patient comfort, satisfaction, and overall quality of postoperative care.

**Study Protocol Overview:**

Patients meeting eligibility criteria (aged over 18, ASA I-III) will be recruited from Health Sciences University Kartal City Hospital and randomly assigned to one of three groups:

1. Group T (Inhaled Lidocaine): Participants will receive 2 ml of 10% lidocaine inhaled via a Tracheo-Spray device before anesthesia induction. This method is expected to coat the mucosal surfaces of the airway, potentially reducing friction and inflammation.
2. Group X (Lidocaine Applied to Tube): Participants will have 10% lidocaine sprayed directly on the distal surface and cuffs of the DLT. This technique aims to provide direct anesthetic coverage on the tube surface, potentially reducing mucosal damage from intubation.
3. Group C (Control): Participants will receive 1 ml of 0.9% saline spray as a placebo.

Data Collection:

The primary outcome measure will be the severity of POST, assessed at 2, 6, 12, and 24 hours postoperatively using a throat pain score (0 to 5 scale). Secondary measures will include hemodynamic parameters (heart rate, systolic and diastolic blood pressures) documented before and after lidocaine application, as well as the incidence of postoperative complications such as hypotension, hypoxemia, hypercapnia, nausea, vomiting, and emergence agitation. Trained investigators will collect data in the operating room, recovery room, and patient wards.

Statistical Analysis:

Data will be analyzed using descriptive and inferential statistics. The Kolmogorov-Smirnov test will assess the normality of data distribution. One-way ANOVA and Bonferroni or Tamhane post-hoc tests will be used for normally distributed variables. For non-parametric variables, the Kruskal-Wallis test and Mann-Whitney U test will be applied. Pearson's chi-square or Fisher's exact test will be used to evaluate qualitative variables, with significance set at p < 0.05.

By comparing different application methods, this study aims to determine an effective approach for reducing POST, which could provide guidance for anesthetic practices in thoracic surgery involving DLTs.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Health Sciences University Kartal City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged over 18 years
• ASA (American Society of Anesthesiologists) scores of 1-3
• Elective thoracic surgery patients

Exclusion Criteria:

• Patients with ASA scores of 4 or above
• Do not consent to participate
• individuals with mental disorders
• patients under 18 years of age
• surgeries exceeding two hours
• those with known allergies to local anesthetic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group T (Inhaled Lidocaine); Participants will receive 2 ml of 10% lidocaine via a Tracheo-Spray device before anesthesia induction.	Drug: Tracheo-Spray; Participants will receive 2 ml of 10% lidocaine delivered via a Tracheo-Spray device to the tracheal mucosa before anesthesia induction.
Experimental: Group X (Lidocaine Applied to the Double-Lumen Tube): Participants will receive 10% lidocaine sprayed directly onto the distal surface and cuffs of the double-lumen tube.	Drug: Lidocaine Spray on DLT; Before intubation, participants will receive 10% lidocaine spray applied to the distal surface and cuffs of the double-lumen tube (DLT).
Sham Comparator: Group C (Control); Participants will receive 1 ml of 0.9% saline as a placebo.	Drug: Saline (Placebo); Before intubation, participants will receive 1 ml of 0.9% saline applied to the distal surface and cuffs of the double-lumen tube (DLT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Sore Throat (POST)	The severity of POST will be assessed at 2, 6, 12, and 24 hours after surgery using a throat pain score, ranging from 0 (no pain) to 5 (worst imaginable pain).	2, 6, 12, and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraperative Hemodynamic Responses	Hypotension: Defined as a decrease of more than 20% in systolic blood pressure from baseline or < 80 mmHg. Hypertension: Defined as an increase of more than 20% in systolic blood pressure from baseline or > 120 mmHg.	Basal measurements and 5 minutes after intubation.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Complications:	Hypotension: Defined as a decrease of more than 20% in systolic blood pressure from baseline or < 80 mmHg. Nausea and Vomiting: Incidence and severity of nausea and vomiting after surgery. Hypoxemia: Defined as SpO2 < 90% or PaO2 < 60 mmHg. Hypercapnia: Defined as PaCO2 > 45 mmHg. Emergence Agitation: The presence and severity of agitation during emergence from anesthesia.	Postoperative 2. 6. 12. and 24. hours

Collaborators and Investigators

• Sponsor: V.K.V. American Hospital, Istanbul

Publications and helpful links

General Publications

• El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
• Tanaka Y, Nakayama T, Nishimori M, Tsujimura Y, Kawaguchi M, Sato Y. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD004081. doi: 10.1002/14651858.CD004081.pub3.
• Chandler M. Tracheal intubation and sore throat: a mechanical explanation. Anaesthesia. 2002 Feb;57(2):155-61. doi: 10.1046/j.1365-2044.2002.02329.x.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Actual): December 6, 2024
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Lidocaine; Sore throat; Lidocaine spray; Double-lumen tube
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: LA&Double-LumenTubes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data that will be shared includes the following: Demographic Information, Postoperative Sore Throat (POST) Scores, Hemodynamic Data, and Intraoperative Complications.

All shared data will be de-identified to protect participant confidentiality, and access will be granted only to researchers who meet the necessary criteria and ethical standards for data use.

IPD Sharing Time Frame

The start date for IPD sharing will be after the completion of the study and the publication of the main study results, approximately June 2025.

End Date for IPD Sharing:

IPD will be available for sharing for a period of 5 years following the publication of the study results, until June 2030.

During this period, researchers who meet the criteria for access will be able to request the de-identified data for secondary analyses.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No