Trial Outcomes & Findings for A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine (NCT NCT04114058)

NCT ID: NCT04114058

Last Updated: 2021-05-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 37 participants
• Primary outcome timeframe: post op days 1-4 (Average VAS score of first 4 days of post op)
• Results posted on: 2021-05-11

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Liposomal Bupivicaine n=20 Participants Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration	Fascia Iliaca Blockade n=17 Participants Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=37 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	17 Participants n=17 Participants	37 Participants n=37 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=17 Participants	0 Participants n=37 Participants
Sex: Female, Male Female	9 Participants n=20 Participants	9 Participants n=17 Participants	18 Participants n=37 Participants
Sex: Female, Male Male	11 Participants n=20 Participants	8 Participants n=17 Participants	19 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	17 participants n=17 Participants	37 participants n=37 Participants
BMI	26.4 Kg/m^2 n=20 Participants	25.7 Kg/m^2 n=17 Participants	26.05 Kg/m^2 n=37 Participants
Traction time	36.0 MINUTES n=20 Participants	36.8 MINUTES n=17 Participants	36.4 MINUTES n=37 Participants
pre-op Visual analogue scale score	3.2 CM n=20 Participants	2.2 CM n=17 Participants	2.7 CM n=37 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivicaine n=20 Participants Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration	Fascia Iliaca Blockade n=17 Participants Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade
Visual Analogue Scale	2.4 cm Interval 1.5 to 3.8	2.7 cm Interval 0.8 to 3.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivicaine n=20 Participants Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration	Fascia Iliaca Blockade n=17 Participants Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade
Narcotic Utilization	7.6 number of pills Interval 0.0 to 12.0	7.8 number of pills Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivicaine n=20 Participants Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration	Fascia Iliaca Blockade n=17 Participants Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade
Total Number of at Home Falls.	0 total number of falls	6 total number of falls

Adverse Events

Liposomal Bupivicaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fascia Iliaca Blockade

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Liposomal Bupivicaine n=20 participants at risk Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration	Fascia Iliaca Blockade n=17 participants at risk Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade
Musculoskeletal and connective tissue disorders fall	0.00% 0/20 • The adverse events occurred through post op days 1-7 for each patient. An adverse event is defined as a fall post op.	35.3% 6/17 • Number of events 6 • The adverse events occurred through post op days 1-7 for each patient. An adverse event is defined as a fall post op.

Additional Information

Dr. Michael Banffy

Cedar Sinai -Kerlan Jobe

Phone: (310) 665-7200

Email: Michael.Banffy@cskerlanjobe.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place