Total Knee Arthroplasty Analgesia: Single-shot Femoral Nerve Block or Epidural?

Postoperative Pain Treatment for Total Knee Arthroplasty Clinical Trial

Official title:

Comparison Between Single-shot Femoral Nerve Block and Epidural Techniques for Total Knee Arthroplasty: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164825
• Other study ID #: CHTSA001
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: February 4, 2015
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: June 2014
• Source: Centro Hospitalar do Tâmega e Sousa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Researc
• Study type: Interventional

Clinical Trial Summary

Single-shot femoral nerve block is similar to continuous epidural technique for postoperative analgesia in total knee arthroplasty

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective total knee arthroplasty

Exclusion Criteria:

• Coagulopathy

• Neuropathy

• Morbid obesity

• local anesthetics allergy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Treatment for Total Knee Arthroplasty

Intervention

Drug:
• Ropivacaine perineural injection
Ultrasound guided single-shot femoral nerve block
• morphine and ropivacaine
Continuous epidural analgesic perfusion Epidural perfusion with morphine and ropivacaine.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Tâmega e Sousa	Penafiel

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar do Tâmega e Sousa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score on the numeric pain score	Patients will be evaluated at 48 hours. At these time frame pain score at rest and during movement will be accessed.	48 hours	No
Secondary	Side effects as a measure of safety and tolerability	Side effects of both interventions. Number of patients with side effects like nausea, vomiting, hypotension and pruritus.	48 hours	Yes
Secondary	Rescue analgesic consumption.	Opioid rescue needs in the first 48 hours after surgery.	48 hours	No
Secondary	Patients satisfaction.	Evaluation of patient´s satisfaction with pain control (asking the patient to classify the grade of satisfaction).	48 hours	No