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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative Ultrasound FICB Group | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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. | From discharge from PACU until discharge from hospital, an average of 2-3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randy Fayne, DO | Beaumont Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Health System | Royal Oak | Michigan | 48073 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data lost for one participant in Intra-operative FICB group leaving 24 analyzed for all measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Data lost for one participant in Intra-operative FICB group leaving 24 analyzed. | Posted | Median | Inter-Quartile Range | units on a scale | From time of PACU admission until discharge from PACU, an average of 2 hours |
|
Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
Small sample size limited conclusions that could be drawn.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randy Fayne, DO | Beaumont Health | 248-898-1905 | rfyane@beaumont.org |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Intra-operative FICB Group | Procedure | 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. |
|
| 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. |
| At the 3 week post-op visit |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | 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. | Data not available for 1 patient in Pre-operative ultrasound FICB group and 3 patients Intra-operative FICB group | Posted | Median | Inter-Quartile Range | units on a scale | From discharge from PACU until discharge from hospital, an average of 2-3 days |
|
|
|
| Secondary | 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. | Data lost for one participant in Intra-operative FICB group leaving 24 analyzed. | Posted | Count of Participants | Participants | From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days. |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | At the 3 week post-op visit |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 6 |
| 25 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 11 | 24 |
| Shivering | General disorders | Systematic Assessment |
|
| Hypotension | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypertension | Blood and lymphatic system disorders | Systematic Assessment |
|
| Swelling of knee/thigh | General disorders | Systematic Assessment |
|
| Swelling of lips | General disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Acute blood loss anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Tape burn | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |