Trial Outcomes & Findings for Efficacy of Fascia Iliaca Block Versus Intraoperative Nerve Infiltration During Anterior Hip Replacement Surgery (NCT NCT01693900)

Last Updated: 2018-02-15

Results Overview

Pain assessments will be made by the subject using a 10.0 cm Visual-Analog scale (VAS) (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) as follows at each time point: * Baseline assessment in Preoperative area * Upon arrival to the post-anesthesia care unit (PACU) * Every 15 min (+/- 2 minutes) thereafter and prior to any request for pain medication until PACU discharge All pain scores per subject from the time of PACU admission until discharge from PACU will be averaged to obtain one data point per subject.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

From time of PACU admission until discharge from PACU, an average of 2 hours

Results posted on

2018-02-15

Participant Flow

This single-center, prospective, randomized study enrolled 50 subjects who were scheduled for elective anterior hip replacement. Once informed consent was obtained, patients were randomized to either preoperative ultrasound-guided fascia iliaca compartment block (FICB) or intraoperative surgeon-placed FICB.

Participant milestones

Participant milestones
Measure	Pre-operative Ultrasound FICB Group Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area. Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.	Intra-operative FICB Group Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Fascia Iliaca Block Versus Intraoperative Nerve Infiltration During Anterior Hip Replacement Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-operative Ultrasound FICB Group n=25 Participants Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area. Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.	Intra-operative FICB Group n=24 Participants Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.	Total n=49 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	25 Participants n=5 Participants	24 Participants n=7 Participants	49 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	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: From time of PACU admission until discharge from PACU, an average of 2 hours

Population: Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.

Outcome measures

Outcome measures
Measure	Pre-operative Ultrasound FICB Group n=25 Participants Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area. Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.	Intra-operative FICB Group n=24 Participants Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.
Postoperative Pain During PACU Admission	40 units on a scale Interval 35.0 to 44.0	36 units on a scale Interval 26.0 to 47.0

PRIMARY outcome

Timeframe: From discharge from PACU until discharge from hospital, an average of 2-3 days

Population: Data not available for 1 patient in Pre-operative ultrasound FICB group and 3 patients Intra-operative FICB group

Pain assessments were made by the subject using a 10.0 cm VAS (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) prior to any request for pain medication. Up to 40 values per patient were averaged.

Outcome measures

Outcome measures
Measure	Pre-operative Ultrasound FICB Group n=24 Participants Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area. Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.	Intra-operative FICB Group n=22 Participants Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.
Postoperative Pain During Recovery	25 units on a scale Interval 15.0 to 50.0	26 units on a scale Interval 11.0 to 38.0

SECONDARY outcome

Timeframe: From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.

Population: Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.

Measure is count of participants experiencing any adverse event. Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.

Outcome measures

Outcome measures
Measure	Pre-operative Ultrasound FICB Group n=25 Participants Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area. Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.	Intra-operative FICB Group n=24 Participants Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.
Incidence of Adverse Events	20 Participants	19 Participants

SECONDARY outcome

Timeframe: At the 3 week post-op visit

Population: Data was obtained for the 25 patients in the pre-operative group and 22 patients in the intra-operative group who responded to 3-week followup phone calls.

Patient satisfaction with postoperative pain control, using a 10 point Likert scale where 1=extremely dissatisfied and 10= extremely satisfied. Patients were called 3 weeks post-op to determine pain control satisfaction.

Outcome measures

Outcome measures
Measure	Pre-operative Ultrasound FICB Group n=25 Participants Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area. Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.	Intra-operative FICB Group n=22 Participants Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.
Patient Satisfaction With Postoperative Pain Control	9.7 units on a scale Standard Deviation 0.6	8.8 units on a scale Standard Deviation 2.2

Adverse Events

Pre-operative Ultrasound FICB Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Intra-operative FICB Group

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pre-operative Ultrasound FICB Group n=25 participants at risk Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area. Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.	Intra-operative FICB Group n=24 participants at risk Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.
General disorders Dizziness	4.0% 1/25 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	4.2% 1/24 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
General disorders Shivering	4.0% 1/25 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	0.00% 0/24 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
Blood and lymphatic system disorders Hypotension	0.00% 0/25 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	4.2% 1/24 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
Blood and lymphatic system disorders Hypertension	0.00% 0/25 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	4.2% 1/24 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
General disorders Swelling of knee/thigh	0.00% 0/25 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	4.2% 1/24 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
General disorders Swelling of lips	4.0% 1/25 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	0.00% 0/24 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
Psychiatric disorders Anxiety	4.0% 1/25 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	0.00% 0/24 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
Blood and lymphatic system disorders Anemia	0.00% 0/25 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	4.2% 1/24 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
Blood and lymphatic system disorders Acute blood loss anemia	4.0% 1/25 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	8.3% 2/24 • Number of events 2 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
Skin and subcutaneous tissue disorders Tape burn	0.00% 0/25 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	4.2% 1/24 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
Gastrointestinal disorders nausea	0.00% 0/25 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	8.3% 2/24 • Number of events 2 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
Gastrointestinal disorders vomiting	4.0% 1/25 • Number of events 1 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.	8.3% 2/24 • Number of events 2 • Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.

Additional Information

Randy Fayne, DO

Beaumont Health

Phone: 248-898-1905

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place