A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04114058
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 8

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and falls in the postoperative period following hip arthroscopy

Condition or Disease	Intervention/Treatment	Phase
Femoro Acetabular Impingement	Drug: liposomal bupivicaine; Procedure: Fascia iliaca blockade	Phase 4

Detailed Description

The purpose the research is to help determine optimal means of post-operative analgesia following hip arthroscopic procedures. Post-operative pain is a significant contributor to patient satisfaction and the side effects of narcotic pain medication are well described. The ideal intervention for achieving appropriate analgesia following hip arthroscopy has not yet been defined. Determining means of achieving acceptable post-operative pain relief while minimizing narcotic usage will help yield maximal patient outcomes.The primary research procedures entailed in this study include fascia iliaca nerve blockade with Marcaine and local field infiltration with liposomal bupivicane (Exparel). The patients in this study will include those who have both a clinical and radiographic diagnosis of femoracetabular impingement (FAI), have failed non operative treatment, and are indicated for hip arthroscopy with labral repair and femoroplasty/acetabuloplasty. The study includes the surgical procedure and the first post-operative follow up visit. The total study duration is approximately 1.5 weeks for each patient. The study will be carried out until the patients first post-operative visit which typically occurs 7-10 days after the procedure. We are to include approximately 40 patients in total for this study over a period of 4 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pain Outcomes Following Hip Arthroscopy: A Prospective Randomized Control Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
• Actual Study Start Date: Oct 29, 2019
• Actual Primary Completion Date: Mar 17, 2020
• Actual Study Completion Date: Mar 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Liposomal Bupivicaine Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control	Drug: liposomal bupivicaine; local field infiltration; Other Names: exparel
Active Comparator: fascia iliaca blockade Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control	Procedure: Fascia iliaca blockade; fascia iliaca compartment blockade

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale [post op days 1-4 (Average VAS score of first 4 days of post op)]

   pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op.

Secondary Outcome Measures

1. Narcotic Utilization [total pill taken over the course of days 1-4 post op.]

   Record of number of narcotic pain pills utilized by patients . This was reported as a total from post op day 1 to 4. The number listed is an average from each patient, from the total pills taken at home.

2. Total Number of at Home Falls. [Post op days 1-7]

   number of falls occurring at home after discharge. This is the total number of falls of all patients in each group, over the first 7 days post op. This is not reported as a mean.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• adult patients (>18 years old)

• diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.

Exclusion Criteria:

• patients undergoing revision procedures, bilateral procedures,

• advanced osteoarthritis (<2mm joint space on plain radiographs)

• frank dysplasia (anterior and/or lateral center edge angles <20 degrees and/or Tonnis angle >15 degrees)

• diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic arthritis, or post traumatic deformity).

• allergy to liposomal bupivicaine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kerlan Jobe	Los Angeles	California	United States	90045

Sponsors and Collaborators

• Cedars-Sinai Medical Center

Investigators

• Principal Investigator: Michael Banffy, MD, Cedars Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 27, 2018

More Information

Publications

• Krych AJ, Baran S, Kuzma SA, Smith HM, Johnson RL, Levy BA. Utility of multimodal analgesia with fascia iliaca blockade for acute pain management following hip arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):843-7. doi: 10.1007/s00167-013-2665-y. Epub 2013 Sep 24.
• Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25. Erratum in: J Arthroplasty. 2019 Feb;34(2):399-400.

• Responsible Party: Michael Banffy, MD, Director, Orthopaedic Sports Medicine Fellowship, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT04114058
• Other Study ID Numbers: Pro00056482
• First Posted: Oct 3, 2019
• Last Update Posted: May 11, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Michael Banffy, MD, Director, Orthopaedic Sports Medicine Fellowship, Cedars-Sinai Medical Center: hip arthroscopy
• Additional relevant MeSH terms: Femoracetabular Impingement; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Liposomal Bupivicaine	Fascia Iliaca Blockade
Arm/Group Description	Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration	Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade
Period Title: Overall Study
STARTED	20	17
COMPLETED	20	17
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Liposomal Bupivicaine	Fascia Iliaca Blockade	Total
Arm/Group Description	Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration	Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade	Total of all reporting groups
Overall Participants	20	17	37
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	17 100%	37 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	9 45%	9 52.9%	18 48.6%
Male	11 55%	8 47.1%	19 51.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	17 100%	37 100%
BMI (Kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [Kg/m^2]	26.4	25.7	26.05
Traction time (MINUTES) [Mean (Full Range) ]
Mean (Full Range) [MINUTES]	36.0	36.8	36.4
pre-op Visual analogue scale score (CM) [Mean (Full Range) ]
Mean (Full Range) [CM]	3.2	2.2	2.7

Outcome Measures

1. Primary Outcome

Title	Visual Analogue Scale
Description	pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op.
Time Frame	post op days 1-4 (Average VAS score of first 4 days of post op)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivicaine	Fascia Iliaca Blockade
Arm/Group Description	Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration	Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade
Measure Participants	20	17
Mean (Full Range) [cm]	2.4	2.7

2. Secondary Outcome

Title	Narcotic Utilization
Description	Record of number of narcotic pain pills utilized by patients . This was reported as a total from post op day 1 to 4. The number listed is an average from each patient, from the total pills taken at home.
Time Frame	total pill taken over the course of days 1-4 post op.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivicaine	Fascia Iliaca Blockade
Arm/Group Description	Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration	Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade
Measure Participants	20	17
Mean (Full Range) [number of pills]	7.6	7.8

3. Secondary Outcome

Title	Total Number of at Home Falls.
Description	number of falls occurring at home after discharge. This is the total number of falls of all patients in each group, over the first 7 days post op. This is not reported as a mean.
Time Frame	Post op days 1-7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivicaine	Fascia Iliaca Blockade
Arm/Group Description	Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration	Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade
Measure Participants	20	17
Number [total number of falls]	0	6

Adverse Events

Time Frame	The adverse events occurred through post op days 1-7 for each patient.
Adverse Event Reporting Description	An adverse event is defined as a fall post op.
Arm/Group Title	Liposomal Bupivicaine		Fascia Iliaca Blockade
Arm/Group Description	Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration		Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade
All Cause Mortality
	Liposomal Bupivicaine		Fascia Iliaca Blockade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/17 (0%)
Serious Adverse Events
	Liposomal Bupivicaine		Fascia Iliaca Blockade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Liposomal Bupivicaine		Fascia Iliaca Blockade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		6/17 (35.3%)
Musculoskeletal and connective tissue disorders
fall	0/20 (0%)	0	6/17 (35.3%)	6

Limitations/Caveats

We did not meet target enrollment due to safety concerns.

More Information

Certain Agreements

All Principal Investigators ARE 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.