## Protocol Section
### Identification Module
**NCT ID:** NCT01323179

**Brief Title:** Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)

**Official Title:** Acute Pain After Fast-track Total Knee Arthroplasty: Preoperative Opioid Versus Non-opioid

#### Organization Study ID Info
**ID:** 11123111
#### Organization
**Class:** OTHER
**Full Name:** Hvidovre University Hospital
### Status Module
#### Completion Date
**Date:** 2013-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-06-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-06-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-02

**Type:** ACTUAL

#### Start Date
**Date:** 2011-03

**Status Verified Date:** 2013-06

#### Study First Post Date
**Date:** 2011-03-25
**Type:** ESTIMATED
**Study First Submit Date:** 2011-03-24
**Study First Submit QC Date:** 2011-03-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hvidovre University Hospital

#### Responsible Party

**Investigator Affiliation:** Hvidovre University Hospital

**Investigator Full Name:** Troels Haxholdt Lunn

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Observational study evaluating pain response after total knee arthroplasty (TKA) in patients taking strong, weak or no opioids preoperatively.

### Conditions Module

**Conditions:**

- Postoperative Pain

**Keywords:**

- Postoperative pain

- Postoperative opioid requirements

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 140

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients taking strong opioids preoperatively

**Label:** Strong opioids

#### Arm Group 2

**Description:** Patients taking weak opioids preoperatively

**Label:** Weak opioids

#### Arm Group 3

**Description:** Patients not taking opioids preoperatively

**Label:** Opioid native

### Outcomes Module

#### Primary Outcomes

**Description:** Pain during ambulation and at rest

**Measure:** Pain

**Time Frame:** 24 hours

#### Secondary Outcomes

**Description:** Pain during ambulation and at rest

**Measure:** Pain

**Time Frame:** 7 days

**Measure:** Opioid consumption

**Time Frame:** 7 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Patients operated with elective, primary, unilateral total knee arthroplasty (TKA) (taking strong or weak opioid daily for minimum 4 weeks or opioid naive patients)

Exclusion Criteria:

* Bilateral / revision arthroplasty
* Disease affection central or peripheral nerve function
* Alcohol and medical abuse
* Daily use of glucocorticoids
* Malignancy
* BMI \> 40
* Dementia or other cognitive dysfunction
* Treatment of anxiety or depression

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients operated with elective, primary, unilateral total knee artroplasty (TKA).

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** Dep. of Anesthesiology, Hvidovre University Hospital

**State:** Hvidovre

**Zip:** 2650

**Location 2:**

**City:** Hellerup

**Country:** Denmark

**Facility:** Dep. of ortopedic surgery, Gentofte Hospital

**Zip:** 2900

**Location 3:**

**City:** Holstebro

**Country:** Denmark

**Facility:** Dep. of ortopedic surgery, Regionshospitalet Holstebro

**Zip:** 7500

**Location 4:**

**City:** Vejle

**Country:** Denmark

**Facility:** Dep. of ortopedic surgery, Vejle Sygehus

**Zip:** 7100

#### Overall Officials

**Official 1:**

**Affiliation:** Dep. of Anesthesiology, Hvidovre University Hospital

**Name:** Troels H Lunn, MD

**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

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Postoperative Pain

- ID: M29525

- Name: Acute Pain

- Relevance: LOW

- As Found: Unknown

- 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

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
