Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT00923598
• Collaborator: The Cleveland Clinic (Other)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%. The basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. For the duration of the study, all patients will receive the current usual and customary analgesics for bilateral TKA patients. All patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (POD) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty; Knee Pain	Drug: 0.1% and 0.4% perineural ropivicaine	Phase 4

Detailed Description

The investigators propose to test the null hypothesis that differing concentrations of ropivacaine (0.1% vs. 0.4%) at an equal total dose has no impact on quadriceps muscle strength during a continuous femoral nerve block following total knee arthroplasty (TKA). These results will help define the optimal concentration of local anesthetic used for continuous peripheral nerve blocks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1) 0.1% Ropivicaine on Right Leg Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.	Drug: 0.1% and 0.4% perineural ropivicaine; Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.
Active Comparator: 2) 0.4% Ropivicaine on Right Leg Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.	Drug: 0.1% and 0.4% perineural ropivicaine; Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.

Outcome Measures

Primary Outcome Measures

1. Quadriceps Femoris Muscle Strength Maximum Voluntary Isometric Contraction (MVIC) [morning of postoperative day 2]

   A device was used called a dynamometer to measure the force during maximum voluntary isometric contraction. The dynamometer was placed on ipsilateral anterior tibia perpendicular to the tibial crest, just proximal to the medial malleolus. Subjects were asked to take 2 seconds to come to maximum effort contracting the quadriceps, maintain this effort for 5 seconds, and then relax.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Primary, bilateral TKA

• Age 18 years or older

• Postoperative analgesic pain includes bilateral continuous femoral nerve blocks

Exclusion Criteria:

• Chronic, high-dose opioid use

• History of opioid abuse

• Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles

• Pregnancy

• Incarceration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Cleveland Clinic, Main Campus	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• University of California, San Diego
• The Cleveland Clinic

Investigators

• Principal Investigator: Daniel I Sessler, M.D., The Cleveland Clinic, Chair, Department of Outcomes Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT00923598
• Other Study ID Numbers: Cleveland TKA Study
• First Posted: Jun 18, 2009
• Last Update Posted: Dec 2, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego: TKA; Bilateral; Cleveland Clinic; UCSD; Catheter; Nerve block; Postoperative pain; Femoral Catheter; Bilateral Total Knee Arthroplasty; Bilateral Femoral Catheter

Study Results

Participant Flow

Arm/Group Title	1) 0.1% Ropivicaine on Right Leg	2) 0.4% Ropivicaine on Right Leg
Arm/Group Description	Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital. 0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.	Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital. 0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.
Period Title: Overall Study
STARTED	23	22
COMPLETED	19	17
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	1) 0.1% Ropivicaine on Right Leg	2) 0.4% Ropivicaine on Right Leg	Total
Arm/Group Description	Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital. 0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.	Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital. 0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.	Total of all reporting groups
Overall Participants	23	22	45
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 78.3%	11 50%	29 64.4%
>=65 years	5 21.7%	11 50%	16 35.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (9)	60 (9)	60 (9)
Sex: Female, Male (Count of Participants)
Female	10 43.5%	11 50%	21 46.7%
Male	13 56.5%	11 50%	24 53.3%
Region of Enrollment (participants) [Number]
United States	23 100%	22 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Quadriceps Femoris Muscle Strength Maximum Voluntary Isometric Contraction (MVIC)
Description	A device was used called a dynamometer to measure the force during maximum voluntary isometric contraction. The dynamometer was placed on ipsilateral anterior tibia perpendicular to the tibial crest, just proximal to the medial malleolus. Subjects were asked to take 2 seconds to come to maximum effort contracting the quadriceps, maintain this effort for 5 seconds, and then relax.
Time Frame	morning of postoperative day 2

Outcome Measure Data

Analysis Population Description

Patients undergoing bilateral knee replacements

Arm/Group Title	1) 0.1% Ropivicaine on Right Leg	2) 0.4% Ropivicaine on Right Leg
Arm/Group Description	Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital. 0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.	Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital. 0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.
Measure Participants	23	22
Mean (Standard Deviation) [newtons]	13 (8)	12 (8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1) 0.1% Ropivicaine on Right Leg, 2) 0.4% Ropivicaine on Right Leg
	Comments
	Type of Statistical Test	Equivalence
	Comments	A method by Armitage et al was used, where by equivalence of treatments would be concluded if the 95% CI for the difference fell within the prespecified tolerated interval. Under these assumptions, a trial with 36 subjects (72 limbs) would correctly conclude there is no treatment difference with probability 80%, and incorrectly conclude equivalence when there is a difference of 20% with probability 5%.
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3
	Confidence Interval	(2-Sided) 95%; -10 to 17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	1) 0.1% Ropivicaine on Right Leg		2) 0.4% Ropivicaine on Right Leg
Arm/Group Description	Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital. 0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.		Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital. 0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.
All Cause Mortality
	1) 0.1% Ropivicaine on Right Leg		2) 0.4% Ropivicaine on Right Leg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)
Serious Adverse Events
	1) 0.1% Ropivicaine on Right Leg		2) 0.4% Ropivicaine on Right Leg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	1) 0.1% Ropivicaine on Right Leg		2) 0.4% Ropivicaine on Right Leg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)

Limitations/Caveats

Study may not be applicable to other catheter designs or insertion techniques; local anesthetic types, concentrations, or doses; infusion delivery methods or durations; and certainly anatomic catheter locations.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.