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

NCT01693900 | Completed Results DMC

• 1 other identifier: 2011-285
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

joint replacement; total hip replacement; regional pain block; ultrasound guidance; fascia iliaca compartment block

Outcome Measures

Primary Outcomes (2)

• 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.

  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

Secondary Outcomes (2)

• Incidence of Adverse Events

  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

  At the 3 week post-op visit

Study Arms (2)

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.

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.

Procedure: Intra-operative FICB Group

Interventions

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.

Pre-operative Ultrasound FICB Group

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.

Intra-operative FICB Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Randy Fayne, DO: lead

Study Sites (1)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Small sample size limited conclusions that could be drawn.

Results Point of Contact

• Title: Randy Fayne, DO
• Organization: Beaumont Health

rfyane@beaumont.org

248-898-1905

Study Officials

• Randy Fayne, DO

  Beaumont Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: September 26, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 15, 2018
• Results First Posted: June 16, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)