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

• Sponsor: Randy Fayne, DO (Other)
• Overall Status: Completed
• CT.gov ID: NCT01693900
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Surgical trauma causes nerve sensitization leading to amplification and prolongation of postoperative pain. In experimental studies, pre-injury neural blockade using local anesthetics has been shown to reduce post-injury sensitization of the central nervous system, while similar techniques applied after the injury had less or no effect (FILOS). Investigators have therefore designed this study to examine the timing of FICB (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing anterior hip replacement surgery.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Procedure: Pre-operative Ultrasound FICB Group; Procedure: Intra-operative FICB Group	N/A

Detailed Description

Though still uncommonly used in the United States, the popularity of the anterior approach for total hip replacement is rapidly growing because of its clinical advantages. Rehabilitation is simplified and accelerated, dislocation risk is reduced, leg length is more accurately controlled, and incision is smaller than with traditional approaches (GOEBEL). Nevertheless, although pain is lessened, it is still considerable, and new techniques have been developed to improve postoperative pain control for this procedure.

Surgical incision and tissue trauma result in postoperative pain. Regional pain blocks, especially when done under ultrasound guidance, have proven to be extremely effective at reducing postoperative pain and improving patient satisfaction. One such block, the fascia iliaca compartment block (FICB), has been shown to be effective in controlling pain associated with surgery involving the hip and femur.

Although possible without ultrasound guidance, using this technique allows for identification of specific tissue planes and precise placement of medication near the nerves responsible for postoperative pain. Using ultrasound, the superficial fascial layer of the iliopsoas muscle is identified at the anterior edge of the ilium, and a needle is placed just beneath that fascia. A high volume of local anesthetic is then injected under ultrasound guidance, ensuring cephalad spread of medication, in an attempt to provide anesthesia of the lateral femoral cutaneous, femoral and obturator nerves.

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. The primary differences in approach (ultrasound guided preop versus direct visualization intraop) is the timing of injection, and it is unclear if nerve block prior to or after tissue damage affects postoperative pain in these patients.

Surgical trauma causes nerve sensitization leading to amplification and prolongation of postoperative pain. In experimental studies, pre-injury neural blockade using local anesthetics has been shown to reduce post-injury sensitization of the central nervous system, while similar techniques applied after the injury had less or no effect (FILOS). Investigators have therefore designed this study to examine the timing of FICB (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing anterior hip replacement surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Fascia Iliaca Block Versus Intraoperative Nerve Infiltration During Anterior Hip Replacement Surgery
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Pre-operative Ultrasound FICB Group; Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under ultrasound guidance with an in-plane technique by a single study investigator in the preoperative area. Although possible without ultrasound guidance, using this technique allows for identification of specific tissue planes and precise placement of medication near the nerves responsible for postoperative pain. Using ultrasound, the superficial fascial layer of the iliopsoas muscle is identified at the anterior edge of the ilium, and a needle is placed just beneath that fascia. A high volume of local anesthetic is then injected under ultrasound guidance, ensuring cephalad spread of medication in an attempt to provide anesthesia of the lateral femoral cutaneous, femoral and obturator nerves.
Active Comparator: 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.	Procedure: 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. 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.

Outcome Measures

Primary Outcome Measures

1. Postoperative Pain During PACU Admission [From time of PACU admission until discharge from PACU, an average of 2 hours]

   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.

2. Postoperative Pain During Recovery [From discharge from PACU until discharge from hospital, an average of 2-3 days]

   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.

Secondary Outcome Measures

1. Incidence of Adverse Events [From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.]

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

2. Patient Satisfaction With Postoperative Pain Control [At the 3 week post-op visit]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults 18-65 years of age

• Female patients must be surgically sterile, postmenopausal or have a negative pregnancy test on the day of surgery

• Willing and able to sign the informed consent approved by the Institutional Review Board (IRB)

• Willing and able to complete the study procedures and pain scales, and to communicate meaningfully in English with study personnel

• Elective anterior hip replacement to be performed at Beaumont Hospital, Royal Oak

• American Society of Anesthesiologists physical status classification 1, 2, and 3 (patients that have either no systemic illness, or mild to moderate systemic disease, eg. asthma, diabetes or hypertension)

Exclusion Criteria:

• History of allergy to study medications including ropivacaine and other local anesthetic agents of the amide-type

• Enrollment in concurrent research study

• Female patients who are pregnant or lactating, or who have a positive urine pregnancy test

• Opioid tolerant, ie, A patient taking a narcotic > 30mg per day morphine equivalent. (Source: www.globalrph.com/narcotic.cgi) for pain in the 2 months prior to surgery

• A medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conducts of the study, or interferes with the pain assessments

• Previous hip arthroplasty (partial or total) of the index hip

• History of illicit drug use, or prescription medicine or alcohol abuse within the past 2 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beaumont Health System	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

• Randy Fayne, DO

Investigators

• Principal Investigator: Randy Fayne, DO, Beaumont Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Randy Fayne, DO, Principle Investigator, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT01693900
• Other Study ID Numbers: 2011-285
• First Posted: Sep 26, 2012
• Last Update Posted: Feb 15, 2018
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Randy Fayne, DO, Principle Investigator, William Beaumont Hospitals: joint replacement; total hip replacement; regional pain block; ultrasound guidance; fascia iliaca compartment block
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

Participant Flow

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.

Arm/Group Title	Pre-operative Ultrasound FICB Group	Intra-operative FICB Group
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

Baseline Characteristics

Arm/Group Title	Pre-operative Ultrasound FICB Group	Intra-operative FICB Group	Total
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 Participants	25	24	49
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	24 100%	49 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	15 60%	12 50%	27 55.1%
Male	10 40%	12 50%	22 44.9%
Region of Enrollment (Count of Participants)
United States	25 100%	24 100%	49 100%

Outcome Measures

1. Primary Outcome

Title	Postoperative Pain During PACU Admission
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

Outcome Measure Data

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
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.
Measure Participants	25	24
Median (Inter-Quartile Range) [units on a scale]	40	36

2. Primary Outcome

Title	Postoperative Pain During Recovery
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

Outcome Measure Data

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
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.
Measure Participants	24	22
Median (Inter-Quartile Range) [units on a scale]	25	26

3. Secondary Outcome

Title	Incidence of Adverse Events
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.

Outcome Measure Data

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
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.
Measure Participants	25	24
Count of Participants [Participants]	20 80%	19 79.2%

4. Secondary Outcome

Title	Patient Satisfaction With Postoperative Pain Control
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

Outcome Measure Data

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
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.
Measure Participants	25	22
Mean (Standard Deviation) [units on a scale]	9.7 (0.6)	8.8 (2.2)

Adverse Events

Time Frame	Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
Arm/Group Title	Pre-operative Ultrasound FICB Group		Intra-operative FICB Group
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)
Serious Adverse Events
	Pre-operative Ultrasound FICB Group		Intra-operative FICB Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Pre-operative Ultrasound FICB Group		Intra-operative FICB Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/25 (24%)		11/24 (45.8%)
Blood and lymphatic system disorders
Hypotension	0/25 (0%)	0	1/24 (4.2%)	1
Hypertension	0/25 (0%)	0	1/24 (4.2%)	1
Anemia	0/25 (0%)	0	1/24 (4.2%)	1
Acute blood loss anemia	1/25 (4%)	1	2/24 (8.3%)	2
Gastrointestinal disorders
nausea	0/25 (0%)	0	2/24 (8.3%)	2
vomiting	1/25 (4%)	1	2/24 (8.3%)	2
General disorders
Dizziness	1/25 (4%)	1	1/24 (4.2%)	1
Shivering	1/25 (4%)	1	0/24 (0%)	0
Swelling of knee/thigh	0/25 (0%)	0	1/24 (4.2%)	1
Swelling of lips	1/25 (4%)	1	0/24 (0%)	0
Psychiatric disorders
Anxiety	1/25 (4%)	1	0/24 (0%)	0
Skin and subcutaneous tissue disorders
Tape burn	0/25 (0%)	0	1/24 (4.2%)	1

Limitations/Caveats

Small sample size limited conclusions that could be drawn.

More Information

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.