## Protocol Section
### Identification Module
**NCT ID:** NCT01291979

**Brief Title:** The Effect of Intravenous Lidocaine on Pain After Tonsillectomy

**Official Title:** Intravenous Lidocaine for Effective Pain Relief After Tonsillectomy: a Prospective, Randomized, Double-blind, Placebo-controlled Study

#### Organization Study ID Info
**ID:** ChungAngUH1
#### Organization
**Class:** OTHER
**Full Name:** Chung-Ang University Hosptial, Chung-Ang University College of Medicine
### Status Module
#### Completion Date
**Date:** 2012-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2011-02-09

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-02-08

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2012-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2011-02

**Status Verified Date:** 2011-02

#### Study First Post Date
**Date:** 2011-02-09
**Type:** ESTIMATED
**Study First Submit Date:** 2011-02-08
**Study First Submit QC Date:** 2011-02-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chung-Ang University Hosptial, Chung-Ang University College of Medicine

#### Responsible Party

**Old Name Title:** Kyung Soo Kim

**Old Organization:** Chung-Ang University Hospital

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing tonsillectomy.

A total of 62 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.

Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.

### Conditions Module

**Conditions:**

- Postoperative Pain

**Keywords:**

- Pain

- Preemptive

- Lidocaine

- Intravenous

- Tonsillectomy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 62

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

**Intervention Names:**

- Drug: Intravenous lidocaine injection

**Label:** Intravenous lidocaine injection group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patients in Group C (placebo control group) received normal saline intravenous injection

**Intervention Names:**

- Drug: Intravenous normal saline injection

**Label:** Placebo control group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intravenous lidocaine injection group

**Description:** Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

**Name:** Intravenous lidocaine injection

**Other Names:**

- IV lidocaine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo control group

**Description:** The patients in Group C (placebo control group) received normal saline intravenous injection

**Name:** Intravenous normal saline injection

**Other Names:**

- IV saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

To check the severity of pain VAS will be measured at post op 4hour.

**Measure:** Visual analogue scale 4hour

**Time Frame:** post op 4hour

#### Secondary Outcomes

**Description:** Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

To check the severity of pain VAS will be measured at post op 12 hour.

**Measure:** visual analogue scale 12 hour

**Time Frame:** Post op 12 hour

**Description:** Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

To check the severity of pain VAS will be measured at post op 12 hour.

**Measure:** visual analogue scale 24hour

**Time Frame:** Post op 12 hour

**Description:** Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

To check the severity of pain VAS will be measured at post op 48 hour.

**Measure:** Visual analogue scale 48hour

**Time Frame:** Post Op 48hour

**Description:** The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 4hour will be measured.

**Measure:** Opioid consumption 4hour

**Time Frame:** Post Op 4hour

**Description:** The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from 12 hour to post op 24 hour will be measured.

**Measure:** Opioid consumption 24hour

**Time Frame:** Post op 24 hour

**Description:** The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 4hour to post op 12 hour will be measured.

**Measure:** Opioid consumption 12 hour

**Time Frame:** Post Op 12 hour

**Description:** The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 24 hour to post op 48 hour will be measured

**Measure:** Opioid consumption 48hour

**Time Frame:** Post Op 48 hour

**Description:** The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 4 hour will be measured.

**Measure:** FPB 4 hour

**Time Frame:** Post Op 4 hour

**Description:** The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) from post op 4 hour to post op 12 hour will be measured.

**Measure:** FPB 12 hour

**Time Frame:** post op 12 hour

**Description:** The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 12 hour to post op 24 hour will be measured.

**Measure:** FPB 24 hour

**Time Frame:** Post Op 24 hour

**Description:** The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 24 hour to post op 48 hour will be measured.

**Measure:** FPB 48 hour

**Time Frame:** Post Op 48 hour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Tonsillectomy

Exclusion Criteria:

* mental change
* allergy to local anesthetics

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** roman00@naver.com

**Name:** Hyun Kang, Ph.D.

**Phone:** 82-2-6299-2571

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** ksdeok@cau.ac.kr

- **Name:** SeongDeok Kim, M.D. & Ph.D.

- **Phone:** +82-2-6299-2571

- **Role:** CONTACT

***Contact 2:***

- **Name:** Hyun Kang, Ph.D.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Kyung Soo Kim, Ph.D.

- **Role:** SUB_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** ChungAng University

**Zip:** 156-755

#### Overall Officials

**Official 1:**

**Affiliation:** Chung-Ang University Hosptial, Chung-Ang University College of Medicine

**Name:** Hyun Kang, Ph.D.

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Chung-Ang University Hosptial, Chung-Ang University College of Medicine

**Name:** KyungSoo Kim, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Postoperative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000061567

- Term: Voltage-Gated Sodium Channel Blockers

- ID: D000026941

- Term: Sodium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11014

- Name: Lidocaine

- Relevance: HIGH

- As Found: Solution

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M23177

- Name: Sodium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M30025

- Name: Diuretics, Potassium Sparing

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008012

- Term: Lidocaine

### Misc Info Module

- Version Holder: 2024-05-24
