Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study

NCT01620047 | Completed Results

• 1 other identifier: TGH-007 IRB # Pro00002055
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Major surgery involving the knee is often associated with severe postoperative pain. Postoperative pain control remains a significant contributor to delayed recovery and length of hospital stay. Approaches to minimize postoperative pain after surgery are a matter of major concern due to the need for early mobilization, a crucial factor in good postoperative rehabilitation. Femoral nerve blocks by either continuous infusion or single injection of anesthetics provide an effective method for analgesia while minimizing the need for systemic opioid therapy, reducing the opioid induced side effects, and facilitating early ambulation. Administration of fentanyl has shown to be a highly effective method to control pain after Total Knee Replacement (TKR). The investigators hypothesize that fentanyl infusions will result in greater post-operative strength in the operative knee.

Conditions

Total Knee Replacement; Primary Knee Arthroplasty

Keywords

Regional Anesthesia; Post-operative pain management; Femoral Nerve Block; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Comparison of Postoperative Strength (Extension)

  To assess extension force postoperatively to discern differences in muscle strength retention between continuous femoral nerve sheath catheter administration of fentanyl or Ropivacaine or a continuous IV infusion of fentanyl.

  24 hours post-surgery

Secondary Outcomes (2)

• VAS Scores and Postoperative Supplemental Morphine Consumption

  24 hours post-surgery

• Serum Fentanyl Levels

  24 hours post-surgery

Study Arms (3)

Femoral Nerve Fentanyl

EXPERIMENTAL

Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).

Drug: Fentanyl

Femoral Nerve Ropivacaine

ACTIVE COMPARATOR

Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).

Drug: Ropivacaine

Intravenous Fentanyl with placebo

PLACEBO COMPARATOR

Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).

Drug: Fentanyl

Interventions

Fentanyl DRUG

Fentanyl 3 µg/ml continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU)through a femoral nerve sheath catheter.

Femoral Nerve Fentanyl

Ropivacaine DRUG

Ropivacaine 0.1% delivered through a femoral nerve sheath catheter continuously for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).

Femoral Nerve Ropivacaine

Eligibility Criteria

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

You may qualify if:

• Patients undergoing unilateral primary total knee replacement
• ASA class I-III
• years and older

You may not qualify if:

• Patient refusal
• Pregnancy
• Coagulopathy
• Adverse/allergic reaction to any opioids or local anesthetics
• History of long-term opioid use (greater than 60 days)
• Infection
• Traumatic lower extremity injury

Sponsors & Collaborators

• University of South Florida: lead
• Tampa General Hospital: collaborator

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (2)

• Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.

  PMID: 21394001 BACKGROUND

• Bauer M, Wang L, Onibonoje OK, Parrett C, Sessler DI, Mounir-Soliman L, Zaky S, Krebs V, Buller LT, Donohue MC, Stevens-Lapsley JE, Ilfeld BM. Continuous femoral nerve blocks: decreasing local anesthetic concentration to minimize quadriceps femoris weakness. Anesthesiology. 2012 Mar;116(3):665-72. doi: 10.1097/ALN.0b013e3182475c35.

  PMID: 22293719 BACKGROUND

Related Links

• American Society of Anesthesiology

MeSH Terms

Interventions

Fentanyl; Ropivacaine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Director of Research
• Organization: Gulf-to-Bay Anesthesiology Associates LLC

rkarlnoski@fgtba.com

813-844-4413

Study Officials

• Devanand Mangar, MD

  Florida Gulf-to-Bay Anesthesiology Associates LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 15, 2012
• Study Start: March 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 11, 2013
• Results First Posted: November 11, 2013

Record last verified: 2013-09

Locations

US (1)