Pain, PostoperativeNCT01693900
Efficacy of Fascia Iliaca Block Versus Intraoperative Nerve Infiltration During Anterior Hip Replacement Surgery
A study testing Pre-operative Ultrasound FICB Group and Intra-operative FICB Group in people with Pain, Postoperative, run by Randy Fayne, DO at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Pre-operative Ultrasound FICB Group and Intra-operative FICB Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Pre-operative Ultrasound FICB Group, Intra-operative FICB Group
- Keywords
- joint replacement, total hip replacement, regional pain block, ultrasound guidance, fascia iliaca compartment block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative Ultrasound FICB GroupProcedure or surgery
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.
Intra-operative FICB GroupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative Ultrasound FICB Group | Experimental | 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. Receives: Procedure: Pre-operative Ultrasound FICB Group |
| Intra-operative FICB Group | Active comparator | 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. Receives: Procedure: Intra-operative FICB Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain During PACU Admission
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.
Measured: From time of PACU admission until discharge from PACU, an average of 2 hours
Postoperative Pain During Recovery
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.
Measured: From discharge from PACU until discharge from hospital, an average of 2-3 days
Secondary outcomes (2)
Incidence of Adverse Events
Measure is count of participants experiencing any adverse event. Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.
Measured: From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.
Patient Satisfaction With Postoperative Pain Control
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.
Measured: At the 3 week post-op visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Randy Fayne, DO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Randy Fayne, DO, Corewell Health East
- Investigators
- Randy Fayne, DO, Principal investigator, Beaumont Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693900
- Sponsor's protocol ID
- 2011-285
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2012
- Last updated
- 15 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fascia Iliaca Block Versus Intraoperative Nerve Infiltration During Anterior Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT01693900
- Acronym / sponsor ID
- 2011-285
- Conditions
- Pain, Postoperative
- Keywords
- joint replacement, total hip replacement, regional pain block, ultrasound guidance, fascia iliaca compartment block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Randy Fayne, DOUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative Ultrasound FICB Group | Experimental | Procedure: Pre-operative Ultrasound FICB GroupEnrolled 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 | Active comparator | Procedure: Intra-operative FICB GroupEnrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative Ultrasound FICB GroupEnrolled 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. | Procedure or surgery | Pre-operative Ultrasound FICB Group |
| Intra-operative FICB GroupEnrolled 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. | Procedure or surgery | Intra-operative FICB Group |
Primary outcome
Postoperative Pain During PACU Admission
Time frame: 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.
Postoperative Pain During Recovery
Time frame: 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.
2 secondary outcomes
Incidence of Adverse Events
Time frame: From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.
Patient Satisfaction With Postoperative Pain Control
Time frame: At the 3 week post-op visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randy Fayne, DO principal investigator
Beaumont Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative Ultrasound FICB Group and Intra-operative FICB Group in people with Pain, Postoperative, run by Randy Fayne, DO at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain During PACU Admission (time frame: From time of PACU admission until discharge from PACU, an average of 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.