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

23 augusti 2017 uppdaterad av: Randy Fayne, DO
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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Michigan
      • Royal Oak, Michigan, Förenta staterna, 48073
        • Beaumont Health System

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Pain During PACU Admission
Tidsram: 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.
From time of PACU admission until discharge from PACU, an average of 2 hours
Postoperative Pain During Recovery
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of Adverse Events
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Huvudutredare: Randy Fayne, DO, Beaumont Health System

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2012

Primärt slutförande (Faktisk)

1 juni 2014

Avslutad studie (Faktisk)

1 januari 2015

Studieregistreringsdatum

Först inskickad

23 augusti 2012

Först inskickad som uppfyllde QC-kriterierna

21 september 2012

Första postat (Uppskatta)

26 september 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 februari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 augusti 2017

Senast verifierad

1 augusti 2017

Mer information

Termer relaterade till denna studie

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Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

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produkt tillverkad i och exporterad från U.S.A.

Nej

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Kliniska prövningar på Smärta, postoperativt

Kliniska prövningar på Pre-operative Ultrasound FICB Group

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