Efficacy of Fascia Iliaca Block Versus Intraoperative Nerve Infiltration During Anterior Hip Replacement Surgery
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Michigan
-
Royal Oak, Michigan, Forente stater, 48073
- Beaumont Health System
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Pain During PACU Admission
Tidsramme: 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:
|
From time of PACU admission until discharge from PACU, an average of 2 hours
|
|
Postoperative Pain During Recovery
Tidsramme: 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.
|
From discharge from PACU until discharge from hospital, an average of 2-3 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Adverse Events
Tidsramme: 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.
|
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
Tidsramme: 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.
|
At the 3 week post-op visit
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Randy Fayne, DO, Beaumont Health System
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2011-285
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .