Trial Outcomes & Findings for A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy (NCT NCT02623361)

Results Overview

highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

within one hour after surgery

Results posted on

2018-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Sham Sham Block: Sham Block by saline injection	FICB Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection
Overall Study STARTED	40	40
Overall Study COMPLETED	40	38
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sham Sham Block: Sham Block by saline injection	FICB Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham n=40 Participants Sham Block: Sham Block by saline injection	FICB n=38 Participants Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection	Total n=78 Participants Total of all reporting groups
Age, Continuous	32 years STANDARD_DEVIATION 9 • n=40 Participants	35 years STANDARD_DEVIATION 11 • n=38 Participants	34 years STANDARD_DEVIATION 10 • n=78 Participants
Sex: Female, Male Female	23 Participants n=40 Participants	15 Participants n=38 Participants	38 Participants n=78 Participants
Sex: Female, Male Male	17 Participants n=40 Participants	23 Participants n=38 Participants	40 Participants n=78 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	40 participants n=40 Participants	38 participants n=38 Participants	78 participants n=78 Participants

PRIMARY outcome

Timeframe: within one hour after surgery

Population: Exclusion criteria for enrollment included age younger than 18 years, contraindications for regional anesthesia, pre-existing neurologic deficits of the lower extremity, and a history of chronic pain requiring chronic opioid medication.

highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)

Outcome measures

Outcome measures
Measure	Sham n=40 Participants Sham Block: Sham Block by saline injection	FICB n=38 Participants Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection
Numeric Pain Score	7 units on the numeric rating scale (0-10) Standard Deviation 2	6 units on the numeric rating scale (0-10) Standard Deviation 2

SECONDARY outcome

Timeframe: 2 hours after surgery

measurement of quadriceps strength (Force) using a dynamometer

Outcome measures

Outcome measures
Measure	Sham n=40 Participants Sham Block: Sham Block by saline injection	FICB n=38 Participants Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection
Leg Strength at Discharge From Ambulatory Center, Surgical Leg	139 Newton Standard Deviation 99	41 Newton Standard Deviation 61

SECONDARY outcome

Timeframe: 48 hours

patient questionaire, patients are contacted 48 h after surgery patient satisfaction is assessed using a questionnaire, applying a scale from 0 to 10, with 0 indicating "not satisfied at all" and 10 indicating "very satisfied"

Outcome measures

Outcome measures
Measure	Sham n=37 Participants Sham Block: Sham Block by saline injection	FICB n=38 Participants Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection
Patient Satisfaction	10 units on the numeric rating scale (0-10) Standard Deviation 0	10 units on the numeric rating scale (0-10) Standard Deviation 1

Adverse Events

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FICB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthias Behrends, PI

UCSF

Phone: 415 476 3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place