Evaluation Exparel Delivered in Knee Replacement

• Sponsor: Maimonides Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02011464
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Pain control after knee replacement requires analgesia to both the top (anterior) and bottom (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion. The investigators want to to examine if giving Exparel into the posterior portion will give better pain relief.

Hypothesis: There is no difference in, the use of analgesics or the length and quality of analgesia and no decrease in the time to be able to accomplish simple to complex knee movements using Exparel infiltration when compared to controls.

Condition or Disease	Intervention/Treatment	Phase
Arthritis	Drug: Exparel; Other: Saline	Phase 4

Detailed Description

Objectives:

1. Is to assess the efficacy of pain control of Exparel vs. controls when injected into the posterior capsular space after total knee arthroplasty

2. Asses the opioid use after Exparel vs. controls

3. Asses the time to simple and complex knee movement and ambulation.

4. The safety of Exparel will be assessed by the occurrence of all postsurgical adverse events and serious adverse events through Day 30.

Methods:

After institutional review board (IRB) approval, 20 subjects will be consented to participate in the study. The study includes subjects undergoing total knee arthroplasty either under general or spinal anesthesia. This study will include men and women (18 - 75 years) who have American Society of Anesthesiologist physical classification status 1 - 3 and underwent total knee arthroplasty.

Subjects will be divided into two groups, Group A (control) to receive 20ml of saline while Group B (study) to receive 20ml of liposomal bupivacaine into the posterior capsular space during total knee arthroplasty. Patients from both groups will receive a femoral nerve block with catheter placement for continuous infusion of local anesthetic. All subjects will have access to rescue analgesics after surgery. Multimodal analgesia will supplement pain as per standard care by the anesthesia team. Tylenol Orally 1g three times daily (not to exceed 4g in 24hrs), oxycontin 10mg orally, twice/day, Celebrex 200 mg orally once a day and Percocet 5/325 prn will serve as this multimodal approach. The time, day and number of requests for break through (additional) analgesia will be noted by both anesthesia team and primary care team. Pain scores will be assessed using a 0 - 10 numeric scale. Pain will be assessed for the following intervals: hospital arrival, post anesthesia care unit (PACU) arrival, 2, 4, 8, 12, 24, 48, 72, hours later and after hospital discharge 10 +/- 5 days after the block. Pain inquiries will assess both posterior and anterior aspects of the knee. Pain at rest and for simple leg movements (knee extension, straight leg raise) to fully ambulatory will be noted. These assessments will be made in conjunction with rehabilitation and physical therapy specialists.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Efficacy of Exparel Delivered Into the Posterior Capsule During Knee Replacement
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exparel infiltration Exparel infiltrated into the posterior compartment of the knee	Drug: Exparel; Exparel is infiltrated into posterior compartment for pain control; Other Names: Bupivacaine
Placebo Comparator: Control Saline infiltrated into posterior compartment	Other: Saline; Saline is infiltrated into posterior compartment for control

Outcome Measures

Primary Outcome Measures

1. Subjective Pain [72 hours post-operative]

   Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain.

Secondary Outcome Measures

1. Post-operative Narcotic Use [72 hours post-operative]

   Average postoperative narcotics administered in total milligrams of morphine equivalents

Other Outcome Measures

1. Side Effects of Analgesia [72 hours post-operative]

   Secondary end points will include the incidence of opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients aged 18-75 years inclusive and American Society of Anesthesiologist physical status 1-3

• Patients undergoing knee replacement (total knee arthroplasty)

• Subjects must be physically and mentally able to participate in the study and complete all study assessments.

• Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of infiltration into the posterior capsule of the knee.

Exclusion Criteria:

• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics

• Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a appropriate Exparel infiltration into the posterior capsule of the knee.

• Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.

• Any subject, who in the opinion of the Investigator, is on chronic pain medicine (opioids), including large doses of non-steroidal anti-inflammatory drugs s.

• Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

• History of pre-existing neurological disorders/neuropathy

• Morbid Obesity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maimonides Medical Center	Brooklyn	New York	United States	11219

Sponsors and Collaborators

• Maimonides Medical Center

Investigators

• Principal Investigator: Piyush Gupta, MD, Maimonides Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maimonides Medical Center
• ClinicalTrials.gov Identifier: NCT02011464
• Other Study ID Numbers: 2013-11-02
• First Posted: Dec 13, 2013
• Last Update Posted: Aug 8, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Arthritis; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Exparel Inflitration	Control
Arm/Group Description	Exparel infiltrated into the posterior compartment of the knee	Saline infiltrated into posterior compartment of the knee
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Exparel Inflitration	Control	Total
Arm/Group Description	Exparel infiltrated into the posterior compartment of the knee	Saline infiltrated into posterior compartment	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.1 (4.7)	62.8 (6.0)	64.1 (5.2)
Sex: Female, Male (Count of Participants)
Female	6 60%	8 80%	14 70%
Male	4 40%	2 20%	6 30%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Pain
Description	Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain.
Time Frame	72 hours post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exparel Group/Average Pain Scores at 4 Hours	Control Group/Average Pain Scores at 4 Hours	Exparel Group/Average Pain Scores at 8 Hours	Control Group/Average Pain Scores at 8 Hours	Exparel Group/Average Pain Scores at 12 Hours	Control Group/Average Pain Scores at 12 Hours	Exparel Group/Average Pain Scores at 24 Hours	Control Group/Average Pain Scores at 24 Hours	Exparel Group/Average Pain Scores at 48 Hours	Control Group/Average Pain Scores at 48 Hours	Exparel Group/Average Pain Scores at 72 Hours	Control Group/Average Pain Scores at 72 Hours
Arm/Group Description	Pain scores using the Number Rating Scale (NRS) from 0 - 10	Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Pain scores using the Number Rating Scale (NRS) from 0 - 10	Pain scores using the Number Rating Scale (NRS) from 0 - 10	Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Pain scores using the Numeric Rating Scale (NRS) 0 - 10
Measure Participants	10	10	10	10	10	10	10	10	10	10	10	10
Mean (Standard Deviation) [units on a scale]	3.80 (3.26)	4.00 (2.75)	3.44 (3.61)	5.30 (3.02)	3.50 (3.25)	3.90 (2.47)	3.80 (3.52)	4.20 (2.82)	2.60 (2.46)	3.50 (2.95)	3.00 (3.16)	3.70 (3.50)

2. Secondary Outcome

Title	Post-operative Narcotic Use
Description	Average postoperative narcotics administered in total milligrams of morphine equivalents
Time Frame	72 hours post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exparel Inflitration	Control
Arm/Group Description	Exparel infiltrated into the posterior compartment of the knee	Saline infiltrated into posterior compartment
Measure Participants	10	10
Mean (Standard Deviation) [mgs]	4.31 (2.40)	5.75 (3.63)

3. Other Pre-specified Outcome

Title	Side Effects of Analgesia
Description	Secondary end points will include the incidence of opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain
Time Frame	72 hours post-operative

Outcome Measure Data

Analysis Population Description

Number of patients with opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain

Arm/Group Title	Exparel Inflitration	Control
Arm/Group Description	Exparel infiltrated into the posterior compartment of the knee	Saline infiltrated into posterior compartment
Measure Participants	10	10
Number [participants]	3 30%	2 20%

Adverse Events

Time Frame	72 hours post-operative
Arm/Group Title	Exparel Inflitration		Control
Arm/Group Description	Exparel infiltrated into the posterior compartment of the knee		Saline infiltrated into posterior compartment
All Cause Mortality
	Exparel Inflitration		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Exparel Inflitration		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Exparel Inflitration		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.