A Study to Compare the Ultrasound-guided Fascia Iliaca Compartment Block (FICB) to Surgeon-placed Fascia Iliaca Compartment Block for Post-operative Pain Control in Patients Undergoing an Anterior Hip Replacement Surgery.

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by William Beaumont Hospitals
Sponsor:
Information provided by (Responsible Party):
Randy Fayne, DO, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01693900
First received: August 23, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Anterior Hip Replacement
Procedure: Pre-operative Ultrasound FICB Group
Procedure: Intra-operative FICB Group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EFFICACY OF FASCIA ILIACA BLOCK VERSUS INTRAOPERATIVE NERVE INFILTRATION DURING ANTERIOR HIP REPLACEMENT SURGERY

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • to determine if timing of FICB affects postoperative pain [ Time Frame: From time of PACU admission until 3 week post-op appointment ] [ Designated as safety issue: No ]

    Pain assessments will be made by the subject using a 10.0 mm VAS and a standard 10 point Likert scale (see attached) 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
    • Prior to every request for pain medication

    A global assessment of postoperative pain and a Post-operative patient satisfaction, using a 10 point Likert scale, will be assessed at the 3 week routine outpatient surgical visit by the study surgeon.



Secondary Outcome Measures:
  • measurement of incidence of adverse events [ Time Frame: Adverse events will be reported by the patient (or when appropriate, staff personnel) from the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days. ] [ Designated as safety issue: No ]
  • comparison of patient satisfaction between the 2 groups [ Time Frame: At the 3 week post-op visit ] [ Designated as safety issue: No ]
    Post-operative patient satisfaction, using a 10 point Likert scale, will be assessed at the 3 week routine outpatient surgical visit by the study surgeon.


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: 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. 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
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.
Procedure: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 IRB (Institutional Review Board)
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693900

Contacts
Contact: Cynthia Turzewski, RN, BSN 248-898-1907 Cynthia.Turzewski@beaumont.edu

Locations
United States, Michigan
Beaumont Health System Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Cynthia Turzewski,RN, BSN    248-898-1907    Cynthia.Turzewksi@beaumont.edu   
Sponsors and Collaborators
Randy Fayne, DO
Investigators
Principal Investigator: Randy Fayne, DO Beaumont Health System
  More Information

No publications provided

Responsible Party: Randy Fayne, DO, Principle Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01693900     History of Changes
Other Study ID Numbers: 2011-285
Study First Received: August 23, 2012
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014