Total Knee ReplacementNCT01620047
Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study
A study testing Fentanyl and Ropivacaine in people with Total Knee Replacement and Primary Knee Arthroplasty, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement, Primary Knee Arthroplasty
- What is being tested?
- Fentanyl and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral primary total knee replacement
- ASA class I-III
- 18 years and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
All subjects scheduled to receive a unilateral, primary total knee replacement were evaluated for eligibility in the preoperative anesthesia center. Adults, older than 18 years of age, ASA I-III were included in the study. Subjects who were either pregnant, on anticoagulant therapy, allergic to opioids, local anesthetics, chronic pain patients, history of traumatic lower extremity injury, or had a body mass index of greater than 35 kg/m2 were excluded from the study.
- Conditions
- Total Knee Replacement, Primary Knee Arthroplasty
- Being tested
- Fentanyl, Ropivacaine
- Keywords
- Regional Anesthesia, Post-operative pain management, Femoral Nerve Block, Total Knee Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
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.
RopivacaineDrug
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).
FentanylDrug
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 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post-surgery
Secondary outcomes (2)
VAS Scores and Postoperative Supplemental Morphine Consumption
Secondary Objective
- To determine the amount of required supplemental analgesia during the postoperative period.
- To determine postoperative analgesia using a Visual Analog Scale (VAS) 0 - 10 centimeter line.
Measured: 24 hours post-surgery
Serum Fentanyl Levels
To identify a difference in serum fentanyl levels among the groups.
Measured: 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Tampa General Hospital
- Responsible party
- Principal investigator, Enrico Camporesi, University of South Florida
- Investigators
- Devanand Mangar, MD, Principal investigator, Florida Gulf-to-Bay Anesthesiology Associates LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620047
- Sponsor's protocol ID
- TGH-007 IRB # Pro00002055
- Status last verified
- Sep 2013
- First submitted
- 12 Jun 2012
- Last updated
- 11 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21394001Bauer 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.
PubMed 22293719
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study
- ClinicalTrials.gov ID
- NCT01620047
- Acronym / sponsor ID
- TGH-007 IRB # Pro00002055
- Conditions
- Total Knee Replacement, Primary Knee Arthroplasty
- Keywords
- Regional Anesthesia, Post-operative pain management, Femoral Nerve Block, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Tampa General Hospital
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Posted 11 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All subjects scheduled to receive a unilateral, primary total knee replacement were evaluated for eligibility in the preoperative anesthesia center. Adults, older than 18 years of age, ASA I-III were included in the study. Subjects who were either pregnant, on anticoagulant therapy, allergic to opioids, local anesthetics, chronic pain patients, history of traumatic lower extremity injury, or had a body mass index of greater than 35 kg/m2 were excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Fentanyl | Experimental | Drug: FentanylFentanyl 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). |
| Femoral Nerve Ropivacaine | Active comparator | Drug: RopivacaineRopivacaine 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). |
| Intravenous Fentanyl with placebo | Placebo comparator | Drug: FentanylControl 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing unilateral primary total knee replacement
- ASA class I-III
- 18 years and older
Key exclusion criteria (7 listed)
- Patient refusal
- Pregnancy
- Coagulopathy
- Adverse/allergic reaction to any opioids or local anesthetics
- History of long-term opioid use (greater than 60 days)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylFentanyl 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. | Drug | Femoral Nerve Fentanyl |
| RopivacaineRopivacaine 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). | Drug | Femoral Nerve Ropivacaine |
| Fentanyl0.9% 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 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 | Intravenous Fentanyl with placebo |
Primary outcome
Comparison of Postoperative Strength (Extension)
Time frame: 24 hours post-surgery
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.
2 secondary outcomes
VAS Scores and Postoperative Supplemental Morphine Consumption
Time frame: 24 hours post-surgery
Serum Fentanyl Levels
Time frame: 24 hours post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21394001Charous 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.
- Background: PubMed 22293719Bauer 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.
- American Society of AnesthesiologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devanand Mangar, MD principal investigator
Florida Gulf-to-Bay Anesthesiology Associates LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl and Ropivacaine in people with Total Knee Replacement and Primary Knee Arthroplasty, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Postoperative Strength (Extension) (time frame: 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01620047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.