## Protocol Section
### Identification Module
**NCT ID:** NCT02607579

**Brief Title:** Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty

**Official Title:** A Randomized, Blinded Study to Compare Exparel and Ropivacaine for Pain Relief Following Total Knee Arthroplasty

#### Organization Study ID Info
**ID:** 14-045
#### Organization
**Class:** OTHER
**Full Name:** Monmouth Medical Center
### Status Module
#### Completion Date
**Date:** 2017-07

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2017-04-27

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-26

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2016-06

**Type:** ACTUAL

#### Start Date
**Date:** 2015-01

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2015-11-18
**Type:** ESTIMATED
**Study First Submit Date:** 2015-07-27
**Study First Submit QC Date:** 2015-11-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Monmouth Medical Center

#### Responsible Party

**Investigator Affiliation:** Monmouth Medical Center

**Investigator Full Name:** Ryan Plyler

**Investigator Title:** Orthopaedic Surgeon/ Researcher

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**Brief Summary:** The purpose of this prospective study is to examine the effect of two local anesthetics used in adductor canal blocks, with relation to pain, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay. The two agents are bupivacaine and ropivacaine. The purpose of this trial is to examine the effect of these drugs being used in adductor canal blocks for pain relief, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay.

**Detailed Description:** Total knee arthroplasty (TKA) is associated with intense early postoperative pain. Effective pain management following total knee arthroplasty is imperative to facilitate early ambulation, mobilization and rehabilitation. The postoperative pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. To manage postoperative pain effectively, multimodal analgesia including acetaminophen, Toradol, Solu-Medrol, opioids and local anesthetics are used. Periarticular infiltration performed intra-operatively combined with ultrasound guided adductor-canal peripheral nerve blocks are effective in reducing pain following a TKA without causing quadriceps motor block which can impede mobilization. There are no published trials that the investigators could find to date, comparing adductor canal block with a single dose Exparel and adductor canal block with standard ropivacaine.

A liposome is a manufactured spherical lipid vesicle that can be used to slowly release a drug thereby extending its duration of action. Exparel is such a compound that slowly releases bupivacaine. Local anesthetics block the conduction of all excitable tissue in a dose related fashion. The first tissues that are affected are nerves, which make these drugs of choice in neural block. Their local adverse effects include neurovascular manifestations are prolonged numbness, tingling, feeling of "pins and needles" or strange sensations. These effects are reversed with time. There are no additional potential risks or adverse effects due to the procedures or drugs being administered. The procedure is well established and the local anesthetics have a history of long term use in humans.

### Conditions Module

**Conditions:**

- Knee Osteoarthritis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This group is given an adductor canal block with Ropivacaine which is the previous gold standard medication.

**Intervention Names:**

- Drug: Ropivacaine

**Label:** Ropivacaine

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** This group is given an adductor canal block with Exparel which is believed to last longer and provide a better pain relief post-operatively.

**Intervention Names:**

- Drug: Exparel

**Label:** Exparel

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exparel

**Name:** Exparel

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Ropivacaine

**Name:** Ropivacaine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The investigators will monitor patient pain scores every 6 hours during the hospital stay based on the Defense and Veterans Pain Rating Scale (DVPRS).

**Measure:** Pain relief

**Time Frame:** Hospital course (approximately 2-3 days)

#### Secondary Outcomes

**Description:** The investigators will compare the length of stay between the two groups.

**Measure:** Length of stay

**Time Frame:** Hospital course (approximately 2-3 days)

**Description:** The investigators will compare the range of motion between the two groups during the participants' hospital course as measured by the physical therapists on a daily basis.

**Measure:** Post-Operative Range of Motion

**Time Frame:** Hospital course (approximately 2-3 days)

**Description:** The investigators will compare the distance walked between the two groups during the participants' hospital course as measured by the physical therapists on a daily basis.

**Measure:** Post-Operative Distance Walked

**Time Frame:** Hospital course (approximately 2-3 days)

**Description:** The investigators will monitor the amount of medication taken by participants during the hospital stay.

**Measure:** Amount of Narcotics required

**Time Frame:** Hospital course (approximately 2-3 days)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18 and up undergoing a total knee replacement with single surgeon. American Society of Anesthesiologists Physical Status Classification Scale (ASA) 1-3.

Exclusion Criteria:

* Allergy to local anesthestic, pre-existing peripheral neuropathy, revision surgery

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Long Branch

**Country:** United States

**Facility:** Monmouth Medical Center

**State:** New Jersey

**Zip:** 07740

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Knee Osteoarthritis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### 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

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1700

- Name: Ropivacaine

- Relevance: HIGH

- As Found: Eye

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077212

- Term: Ropivacaine

### Misc Info Module

- Version Holder: 2024-05-24
