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

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ClinicalTrials.gov Identifier: NCT01693900
Recruitment Status : Completed
First Posted : September 26, 2012
Results First Posted : June 16, 2017
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Randy Fayne, DO, William Beaumont Hospitals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain, Postoperative
Interventions Procedure: Pre-operative Ultrasound FICB Group
Procedure: Intra-operative FICB Group
Enrollment 50
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Pre-operative Ultrasound FICB Group Intra-operative FICB Group
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Pre-operative Ultrasound FICB Group Intra-operative FICB Group Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 25 24 49
Hide Baseline Analysis Population Description
Data lost for one participant in Intra-operative FICB group leaving 24 analyzed for all measures.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
24
 100.0%
49
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
Female
15
  60.0%
12
  50.0%
27
  55.1%
Male
10
  40.0%
12
  50.0%
22
  44.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 24 participants 49 participants
25
 100.0%
24
 100.0%
49
 100.0%
1.Primary Outcome
Title Postoperative Pain During PACU Admission
Hide Description

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.
Time Frame From time of PACU admission until discharge from PACU, an average of 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.
Arm/Group Title Pre-operative Ultrasound FICB Group Intra-operative FICB Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 25 24
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
40
(35 to 44)
36
(26 to 47)
2.Primary Outcome
Title Postoperative Pain During Recovery
Hide Description 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.
Time Frame From discharge from PACU until discharge from hospital, an average of 2-3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available for 1 patient in Pre-operative ultrasound FICB group and 3 patients Intra-operative FICB group
Arm/Group Title Pre-operative Ultrasound FICB Group Intra-operative FICB Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 24 22
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
25
(15 to 50)
26
(11 to 38)
3.Secondary Outcome
Title Incidence of Adverse Events
Hide Description Measure is count of participants experiencing any adverse event. Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.
Time Frame From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.
Arm/Group Title Pre-operative Ultrasound FICB Group Intra-operative FICB Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
20
  80.0%
19
  79.2%
4.Secondary Outcome
Title Patient Satisfaction With Postoperative Pain Control
Hide Description 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.
Time Frame At the 3 week post-op visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pre-operative Ultrasound FICB Group Intra-operative FICB Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 25 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.7  (0.6) 8.8  (2.2)
Time Frame Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pre-operative Ultrasound FICB Group Intra-operative FICB Group
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Pre-operative Ultrasound FICB Group Intra-operative FICB Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pre-operative Ultrasound FICB Group Intra-operative FICB Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Pre-operative Ultrasound FICB Group Intra-operative FICB Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/25 (24.00%)      11/24 (45.83%)    
Blood and lymphatic system disorders     
Hypotension   0/25 (0.00%)  0 1/24 (4.17%)  1
Hypertension   0/25 (0.00%)  0 1/24 (4.17%)  1
Anemia   0/25 (0.00%)  0 1/24 (4.17%)  1
Acute blood loss anemia   1/25 (4.00%)  1 2/24 (8.33%)  2
Gastrointestinal disorders     
nausea   0/25 (0.00%)  0 2/24 (8.33%)  2
vomiting   1/25 (4.00%)  1 2/24 (8.33%)  2
General disorders     
Dizziness   1/25 (4.00%)  1 1/24 (4.17%)  1
Shivering   1/25 (4.00%)  1 0/24 (0.00%)  0
Swelling of knee/thigh   0/25 (0.00%)  0 1/24 (4.17%)  1
Swelling of lips   1/25 (4.00%)  1 0/24 (0.00%)  0
Psychiatric disorders     
Anxiety   1/25 (4.00%)  1 0/24 (0.00%)  0
Skin and subcutaneous tissue disorders     
Tape burn   0/25 (0.00%)  0 1/24 (4.17%)  1
Indicates events were collected by systematic assessment
Small sample size limited conclusions that could be drawn.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Randy Fayne, DO
Organization: Beaumont Health
Phone: 248-898-1905
Responsible Party: Randy Fayne, DO, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01693900     History of Changes
Other Study ID Numbers: 2011-285
First Submitted: August 23, 2012
First Posted: September 26, 2012
Results First Submitted: January 9, 2017
Results First Posted: June 16, 2017
Last Update Posted: February 15, 2018