Comparing Femoral Nerve Catheters to Single Shot Femoral Nerve Blocks for Total Knee Replacement Surgery

NCT02106481 | Completed DMC

• 1 other identifier: 14-1-M-255
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two methods of pain control used during total knee joint replacement surgery. The pain medication that will be used for this study is not experimental. The investigators will compare the single shot femoral nerve block (SSFNB) and Femoral Nerve Block (FNB) plus continuous femoral nerve catheter (CFNC) to determine which method gives patients better pain control, increasing the capability to participate in physical therapy and decreasing the consumption of other pain medication. With either the single shot or the catheter the local numbing medication called ropivacaine will be used.

Conditions

Knee Osteoarthritis

Keywords

TKA; TKR; Knee OA; pain management; Femoral Nerve Catheter; Single Shot Femoral Nerve Blocks

Outcome Measures

Primary Outcomes (1)

• Pain

  Pain Analog Scale- 0-10 were 10 is the worst possible pain and 0 is no pain at all.

  48 hours post operatively

Other Outcomes (5)

• Restfulness of sleep

  8 AM post op day 1

• Nausea and Vomiting

  8 AM post op day 1

• Distance Walked

  8 AM post op day 1, 48 hours post op, 3 months post op

Study Arms (2)

Femoral Nerve Catheters

ACTIVE COMPARATOR

Patients will receive a Single Shot Femoral Nerve Block along with a conventional continuous femoral nerve catheter

Drug: Femoral Nerve Catheters; Drug: Single Shot Femoral Nerve Blocks

Single Shot Femoral Nerve Blocks

ACTIVE COMPARATOR

Patients will receive a Single Shot Femoral Nerve Block and a sham catheter post op.

Drug: Single Shot Femoral Nerve Blocks

Interventions

Femoral Nerve Catheters DRUG

Catheter will be bolused with 0.5 % ropivacaine around the femoral nerve and occlusive dressing applied over the catheter. Patients with CFNB will receive ropivacaine 0.2% infusion (the infusion rate will be dependent on the clinical judgement of the anaesthesiologist)

Also known as: 0.5% ropivacaine bolus followed by 0.2% infusion

Femoral Nerve Catheters

Single Shot Femoral Nerve Blocks DRUG

The group with SSFNB will receive a femoral nerve block before the surgery in the pre-operative area guided by a nerve stimulator and ultrasound. A bolus of 0.5 % ropivacaine will be injected around the femoral nerve.

Also known as: 0.5% ropivacaine

Femoral Nerve Catheters; Single Shot Femoral Nerve Blocks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18-80 years old)
• Scheduled to undergo primary unilateral TKA with Parapatellar approach
• Patient agrees to participate in the study
• Effective femoral nerve block
• No contraindication for spinal or regional anesthesia

You may not qualify if:

• History of opioid dependence or current chronic analgesic therapy (daily use \>4 weeks
• Allergy to study medications
• Known hepatic or renal insufficiency/disease
• Peripheral neuropathy
• Morbid obesity (BMI \>40 kg/m2)
• Unable to comply with study protocol
• Pregnancy
• Incarceration

Sponsors & Collaborators

• Eastern Maine Medical Center: lead

Study Sites (1)

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Varun Dixit, MD

  Eastern Maine Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

US (1)