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

Femoro Acetabular Impingement Clinical Trial

Official title:

Pain Outcomes Following Hip Arthroscopy: A Prospective Randomized Control Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114058
• Other study ID #: Pro00056482
• Status: Completed
• Phase: Phase 4
• Start date: October 29, 2019
• Est. completion date: March 17, 2020

Study information

• Verified date: April 2021
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoro Acetabular Impingement

Intervention

Drug:
• liposomal bupivicaine
local field infiltration

Procedure:
• Fascia iliaca blockade
fascia iliaca compartment blockade

Locations

Country	Name	City	State
United States	Kerlan Jobe	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	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.	post op days 1-4 (Average VAS score of first 4 days of post op)
Secondary	Narcotic Utilization	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.	total pill taken over the course of days 1-4 post op.
Secondary	Total Number of at Home Falls.	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.	Post op days 1-7