## Protocol Section
### Identification Module
**NCT ID:** NCT03843879

**Brief Title:** TAP Blocks vs. IV Lidocaine for Kidney Transplants

**Official Title:** A Comparison of Transversus Abdominis Plane Blocks Versus Continuous Intravenous Lidocaine for Kidney Transplant Surgery

#### Organization Study ID Info
**ID:** IRB18-109
#### Organization
**Class:** OTHER
**Full Name:** Benaroya Research Institute
### Status Module
#### Completion Date
**Date:** 2021-09-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-07-17

**Type:** ACTUAL

**Last Update Submit Date:** 2019-07-15

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-03-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-04-01

**Type:** ACTUAL

**Status Verified Date:** 2019-07

#### Study First Post Date
**Date:** 2019-02-18
**Type:** ACTUAL
**Study First Submit Date:** 2019-02-14
**Study First Submit QC Date:** 2019-02-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Benaroya Research Institute

#### Responsible Party

**Investigator Affiliation:** Benaroya Research Institute

**Investigator Full Name:** Neil Hanson

**Investigator Title:** Anesthesiologist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will compare continuous intravenous lidocaine against single-injection transversus abdominis plane (TAP) block as a modality for postoperative analgesia in kidney transplant surgery.

**Detailed Description:** This study is a non-inferiority trial designed to assess the analgesic efficacy of an intravenous (IV) lidocaine infusion against single-injection transversus abdominis plane (TAP) block in patients undergoing kidney transplant surgery. The investigators propose a study of 124 subjects randomized into two groups. The control group will receive a TAP block. The study group will receive a continuous IV lidocaine infusion. The investigators hypothesize that there will be no statistically significant difference in postoperative opioid consumption between the two groups in the first 24 hours.

### Conditions Module

**Conditions:**

- Postoperative Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 124

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Single-injection transversus abdominis plane block

**Intervention Names:**

- Procedure: Transversus Abdominis Plane Block

**Label:** TAP Block

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Continuous intravenous lidocaine infusion

**Intervention Names:**

- Drug: Intravenous Lidocaine

**Label:** IV Lidocaine

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TAP Block

**Description:** Single-injection transversus abdominis plane block with 30 mL of 0.25% Bupivacaine with 1:400,000 epinephrine

**Name:** Transversus Abdominis Plane Block

**Other Names:**

- TAP Block

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- IV Lidocaine

**Description:** Continuous intravenous lidocaine infusion

**Name:** Intravenous Lidocaine

**Other Names:**

- Continuous intravenous lidocaine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Total opioid utilization

**Measure:** Opioid Consumption

**Time Frame:** 0-24 Hours

#### Secondary Outcomes

**Description:** Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)

**Measure:** Pain Scores

**Time Frame:** 0-48 Hours

**Description:** Total opioid utilization

**Measure:** Opioid Consumption

**Time Frame:** 24-48 Hours

**Description:** Nausea, Vomiting, Pruritis, Respiratory Depression, Constipation

**Measure:** Opioid-Related Adverse Events

**Time Frame:** 0-48 Hours

**Description:** Local Anesthetic Systemic Toxicity

**Measure:** Block/Infusion-Related Adverse Events

**Time Frame:** 0-48 Hours

**Description:** Use of prescribed opioids

**Measure:** Opioid Usage

**Time Frame:** 30 days from discharge

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Kidney transplant recipient
* \>18 years old
* Consent to participate

Exclusion Criteria:

* \<18 years old
* Refusal to participate
* Chronic opioid use
* Seizure disorder
* Allergy to local anesthestics
* Severe hepatic disease

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** neil.hanson@virginiamason.org

**Name:** Neil A Hanson, MD

**Phone:** 206-223-6980

**Role:** CONTACT

**Contact 2:**

**Email:** wyndam.strodtbeck@virginiamason.org

**Name:** Wyndam M Strodtbeck, MD

**Phone:** 206-223-6980

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seattle

**Contacts:**

***Contact 1:***

- **Email:** neil.hanson@virginiamason.org

- **Name:** Neil A Hanson, MD

- **Role:** CONTACT

***Contact 2:***

- **Email:** wyndam.strodtbeck@virginiamason.org

- **Name:** Wyndam M Strodtbeck, MD

- **Role:** CONTACT

**Country:** United States

**Facility:** Virginia Mason Medical Center

**State:** Washington

**Status:** RECRUITING

**Zip:** 98101

#### Overall Officials

**Official 1:**

**Affiliation:** Virginia Mason Medical Center

**Name:** Neil A Hanson, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Hanson NA, Strunk J, Saunders G, Cowan NG, Brandenberger J, Kuhr CS, Oryhan C, Warren DT, Slee AE, Strodtbeck W. Comparison of continuous intravenous lidocaine versus transversus abdominis plane block for kidney transplant surgery: a randomized, non-inferiority trial. Reg Anesth Pain Med. 2021 Nov;46(11):955-959. doi: 10.1136/rapm-2021-102973. Epub 2021 Aug 20.

**PMID:** 34417343

## 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

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M11014

- Name: Lidocaine

- Relevance: HIGH

- As Found: Solution

- ID: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M7992

- Name: Epinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M30371

- Name: Racepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M211043

- Name: Epinephryl borate

- Relevance: LOW

- As Found: Unknown

- 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
