## Protocol Section
### Identification Module
**NCT ID:** NCT05171179

**Brief Title:** The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery

**Official Title:** A Prospective, Randomized Controlled Trial Investigating Pecs Blocks Types I and II as a Method for Administering the Non-Opioid Anesthetic Exparel in Order to Mitigate Postoperative Narcotic Usage, Pain, Nausea, and Hospital Stay in Patients Undergoing Implant-Based Tissue Expander Breast Reconstruction Surgery

#### Organization Study ID Info
**ID:** STU00214187
#### Organization
**Class:** OTHER
**Full Name:** Northwestern University
### Status Module
#### Completion Date
**Date:** 2024-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-09

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-10-22

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2021-12-28
**Type:** ACTUAL
**Study First Submit Date:** 2021-11-04
**Study First Submit QC Date:** 2021-12-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Pacira Pharmaceuticals, Inc

#### Lead Sponsor

**Class:** OTHER

**Name:** Northwestern University

#### Responsible Party

**Investigator Affiliation:** Northwestern University

**Investigator Full Name:** Robert Galiano

**Investigator Title:** Associate Professor of Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. The hypothesis is that this analgesic delivery method will significantly reduce negative outcomes such as post-operative pain, opioid use, and nausea while increasing positive outcomes such as post-operative physical activity.

**Detailed Description:** The research team will be investigating the use of a novel type of local drug administration as well as assessing whether a non-opioid based drug will result in more positive pain outcomes while reducing reliance on narcotics (opioid-based drugs) following surgery.

The drug administration tool, called the Pecs blocks types I and II, utilizes ultrasound to help guide anesthetic injection for local anesthesia. This has been an effective way to deliver local anesthetic during breast surgeries. Meanwhile, a non-opioid analgesic drug (similar to an anesthetic, meaning it is used during surgery to reduce pain) called Exparel has been shown to reduce post-operative use of narcotics, length of stay in hospitals, and pain compared to the current standards in breast reconstruction surgery. Exparel is approved by the FDA for use in surgical sites during breast reconstruction surgery. Exparel has shown to reduce pain and post-surgical nausea and vomiting in breast reconstruction patients. However, the combination of Exparel with Pecs blocks has not been examined in breast reconstruction surgery, and the research team suspects that breast reconstruction patients who are administered Exparel with Pecs blocks will experience less pain, increased mobility, and less nausea following surgery. Furthermore, the researchers hope to show that this non-opioid based drug successfully reduces the necessity to use narcotics following surgery. Narcotics are highly addictive and can lead to dependency following surgery.

The reason the project has three different groups in this study is to show if each group has different outcomes. First, the project hopes to see a difference between the Pecs blocks and normal anesthesia delivery. Then, researchers hope to see a difference between the two Pecs blocks group where the use of Exparel will result in less narcotic use, pain, nausea, and increase mobility.

### Conditions Module

**Conditions:**

- Mammaplasty

**Keywords:**

- breast reconstruction

- mammaplasty

- analgesic

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 1. Group 1 (Control): Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol)
2. Group 2: Use of Pecs block types I and II with bupivacaine as local anesthetic
3. Group 3: Use of Pecs block types I and II with mixture of bupivacaine and Exparel\* (\*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel and in ability to use lidocaine infusion with injection of Exparel)

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Patient will be randomized into one of the three trial arms. Randomization process will involve 90 envelopes, 30 of which will contain assignment to the study arm with Exparel blocks, 30 which will contain assignment to bupivacaine blocks, and 30 which will contain assignment to lidocaine infusion (the control arm). The PI's attending nurse will randomly distribute an envelope to the study team between V1 and V2. V2, the day of surgery, will be the only visit where the patient would potentially have contact with the treatments. The patient will not be aware of what treatment they receive until after their 2-week follow-up.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol)

**Intervention Names:**

- Procedure: Breast Reconstruction (Mammaplasty)

- Drug: Lidocaine

**Label:** Intravenous lidocaine

**Type:** OTHER

#### Arm Group 2

**Description:** Use of Pecs block types I and II with bupivacaine as local anesthetic

**Intervention Names:**

- Procedure: Breast Reconstruction (Mammaplasty)

- Device: Pecs blocks

- Drug: Bupivacaine

**Label:** Blocks+Bupivacaine

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Use of Pecs block types I and II with mixture of bupivacaine and Exparel\* (\*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel and in ability to use lidocaine infusion with injection of Exparel)

**Intervention Names:**

- Procedure: Breast Reconstruction (Mammaplasty)

- Device: Pecs blocks

- Drug: Exparel

- Drug: Bupivacaine

**Label:** Blocks+Bupivacaine+Exparel

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Blocks+Bupivacaine

- Blocks+Bupivacaine+Exparel

- Intravenous lidocaine

**Description:** Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander

**Name:** Breast Reconstruction (Mammaplasty)

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Blocks+Bupivacaine

- Blocks+Bupivacaine+Exparel

**Description:** Pectoral nerve (Pecs) blocks I and II function by blocking the pectoral, intercostal, intercostobrachial nerves, and/or long thoracic nerve. These are used primarily for breast surgeries and are gaining momentum as simple administers of local analgesics. Pecs blocks utilize ultrasound to guide injection of local analgesic. It is less invasive and more accurate than most current modes of analgesia administration.

**Name:** Pecs blocks

**Other Names:**

- Pecs blocks I and II

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- Blocks+Bupivacaine+Exparel

**Description:** Exparel is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam® drug delivery system) containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of Exparel, bupivacaine is released from the multivesicular liposomes over a period of time.

**Name:** Exparel

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Blocks+Bupivacaine

- Blocks+Bupivacaine+Exparel

**Description:** This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in arms 2 and 3.

**Name:** Bupivacaine

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Intravenous lidocaine

**Description:** This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in arm 1.

**Name:** Lidocaine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** • Investigate amount of post-operative opioid consumption post operatively

**Measure:** Opioid consumption

**Time Frame:** 2 weeks post op

#### Secondary Outcomes

**Description:** • Assess Post-Operative Nausea scores among the three arms using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten, where ten is the most nausea experienced

**Measure:** Nausea

**Time Frame:** 2 weeks post op

**Description:** • Assess post-operative mobility using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten where ten is the most immobile

**Measure:** Mobility

**Time Frame:** 2 weeks post op

**Description:** • Assess the pain patients experience throughout their recovery period using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten where ten is the highest pain

**Measure:** Pain Outcomes

**Time Frame:** 2 weeks post op

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Subjects greater than 18 years of age.
2. Subject who are undergoing implant-based, tissue expander breast reconstruction surgery.

Exclusion Criteria:

1. Subjects undergoing flap breast reconstruction.
2. Subjects who are undergoing direct-to-implant surgery.
3. Subjects who have previously undergone radiation therapy.
4. Medical or psychiatric condition that may increase the risk associated with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
5. Subjects who are pregnant at the date of surgery.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** robert.galiano@nm.org

**Name:** Robert Galiano, MD

**Phone:** 3126956022

**Role:** CONTACT

**Contact 2:**

**Email:** peter.ullrich@nm.org

**Name:** Peter Ullrich

**Phone:** 3129267037

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** robert.galiano@nm.org

- **Name:** Robert Galiano, MD

- **Phone:** 312-695-6022

- **Role:** CONTACT

***Contact 2:***

- **Email:** peter.ullrich@nm.org

- **Name:** Peter Ullrich

- **Phone:** 3129267037

- **Role:** CONTACT

***Contact 3:***

- **Name:** Mahesh Vaidyanathan, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Robert Galiano, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Northwestern Memorial Hospital

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60611

#### Overall Officials

**Official 1:**

**Affiliation:** 3126956022

**Name:** Robert Galiano, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12273

- Name: Nausea

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### 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: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M11014

- Name: Lidocaine

- Relevance: HIGH

- As Found: Solution

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M5315

- Name: Bupivacaine

- Relevance: HIGH

- As Found: Following

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- 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

- ID: D000002045

- Term: Bupivacaine

### Misc Info Module

- Version Holder: 2024-05-24
