Trial Outcomes & Findings for Hip Scope Fascia-iliaca (FI) Block Study (NCT NCT02365961)

NCT ID: NCT02365961

Last Updated: 2019-03-14

Results Overview

Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 84 participants
• Primary outcome timeframe: 3 Months
• Results posted on: 2019-03-14

Participant Flow

Participant milestones

Measure	FI Block Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine	Local Injection Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin
Overall Study STARTED	41	43
Overall Study COMPLETED	41	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hip Scope Fascia-iliaca (FI) Block Study

Baseline characteristics by cohort

Measure	FI Block n=41 Participants Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine	Local Injection n=43 Participants Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	43 Participants n=7 Participants	84 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	43 participants n=7 Participants	84 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale.

Outcome measures

Measure	FI Block n=41 Participants Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine	Local Injection n=43 Participants Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin
Visual Analog Scale	2.65 units on a scale Interval 1.91 to 3.38	2.50 units on a scale Interval 1.77 to 3.23

SECONDARY outcome

Timeframe: 3 Months

Opioid consumption, as measured by narcotic usage (morphine milligram equivalents)

Outcome measures

Measure	FI Block n=41 Participants Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine	Local Injection n=43 Participants Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin
Opioid Consumption	26.87 morphine milligram equivalents Interval 22.37 to 31.38	30.32 morphine milligram equivalents Interval 26.03 to 34.61

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of PACU stay in minutes from end of surgery to discharge from PACA

Measured time subjects spent in the post anesthesia care unit.

Outcome measures

Measure	FI Block n=41 Participants Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine	Local Injection n=43 Participants Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin
Time in PACU	150.04 Minutes Interval 128.95 to 171.2	151.59 Minutes Interval 131.52 to 171.67

OTHER_PRE_SPECIFIED outcome

Timeframe: From end of surgery to discharge from PACU

Occurrences of periods of nausea and vomiting

Outcome measures

Measure	FI Block n=41 Participants Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine	Local Injection n=43 Participants Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin
Total Number of Episodes of Nausea and Vomiting	11 Number of episodes	7 Number of episodes

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Number of participants that were readmitted to the hospital

Outcome measures

Measure	FI Block n=41 Participants Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine	Local Injection n=43 Participants Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin
Hospital Readmission	1 Participants	2 Participants

Adverse Events

FI Block

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Local Injection

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	FI Block n=41 participants at risk Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine	Local Injection n=43 participants at risk Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin
General disorders Hospital readmission	2.4% 1/41 • Number of events 1 • Patients were assessed throughout their study participation, from surgery through the 3 month follow up. Both treatment are standard of care.	2.3% 1/43 • Number of events 1 • Patients were assessed throughout their study participation, from surgery through the 3 month follow up. Both treatment are standard of care.

Additional Information

Hawkins Foundation Research Coordinator

Hawkins Foundation

Phone: 864 454 7458

Email: info@hawkinsfoundation.com

Results disclosure agreements

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