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A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02623361
Recruitment Status : Completed
First Posted : December 7, 2015
Results First Posted : July 5, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

Patients undergoing arthroscopic hip surgery have been shown to have significant post-operative pain that may delay discharge, recovery, and early mobilisation. A pre-operative regional anesthesia technique, the fascia iliaca block may be an effective method for acute post-operative analgesia.

This is a prospective, randomized controlled study of the preoperative fascia iliaca block for patients undergoing hip arthroscopy.

The enrolled patients will be randomized to receive either a fascia iliaca block with the local anesthetic ropivacaine or to have a sham block. All patients will receive a general anesthetic for the hip arthroscopy.


Condition or disease Intervention/treatment Phase
Muscle Weakness | Patient Pain Drug: Peripheral Nerve Block Drug: Sham Block Phase 4

Detailed Description:

Arthroscopic hip surgery is used to diagnose and treat interior joint pathology. Although minimally invasive in nature, patients have considerable amount of pain postoperatively, leading to prolonged recovery room stay and increased opiate requirements. The investigators performed a retrospective chart review in patients who underwent hip arthroscopy at the UCSF Orthopedic Institute. 89% of the patients had pain immediate after surgery requiring opioid therapy. Regional anesthesia has previously been shown to reduce discomfort after hip arthroscopy. However, there is currently no safe, well-established ultrasound guided regional anesthesia technique for arthroscopic hip surgery. The fascia iliaca block has shown to decrease acute pain related with hip fractures, as well as pain related with knee arthroplasty. The ultrasound guided fascia iliaca block is easy to perform and has an excellent safety record. The investigators believe that the ultrasound guided fascia iliaca block improves pain control in patients undergoing arthroscopic hip surgery.

Patients will receive a sham block group or a fascia iliaca block, performed in the preoperative area.

Pain scores and measurement of quadriceps strength will be assessed preoperatively and postoperatively. The patient will receive a pain diary consisting of pain scores, pain medication consumption, and a brief pain inventory. Within 48 hours postoperatively, an anesthesiologist will call the patient and review the patient's pain scores, pain medication consumption and brief pain inventory.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy
Actual Study Start Date : February 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Placebo Comparator: Sham Drug: Sham Block
Sham Block by saline injection

Active Comparator: Fascia Iliaca Compartment Block Drug: Peripheral Nerve Block
Regional Anesthesia by Local Anesthetic Injection




Primary Outcome Measures :
  1. Numeric Pain Score [ Time Frame: within one hour after surgery ]
    highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)


Secondary Outcome Measures :
  1. Leg Strength at Discharge From Ambulatory Center, Surgical Leg [ Time Frame: 2 hours after surgery ]
    measurement of quadriceps strength (Force) using a dynamometer

  2. Patient Satisfaction [ Time Frame: 48 hours ]

    patient questionaire, patients are contacted 48 h after surgery

    patient satisfaction is assessed using a questionnaire, applying a scale from 0 to 10, with 0 indicating "not satisfied at all" and 10 indicating "very satisfied"




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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at least 18 years old
  • American Society of Anesthesia physical classification I - III, scheduled for arthroscopic hip surgery

Exclusion Criteria:

  • Age younger than 18 years old
  • Non-English speaking
  • Contraindicated for regional nerve block (such as, but not limited to: coagulopathy, infection at site, allergy to local anesthetic)
  • Preexisting neurologic deficits of operative limb
  • Need for postoperative nerve function test
  • Inability to consent due to cognitive dysfunction
  • Chronic pain
  • Patient refusal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623361


Locations
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United States, California
Orthopedic Institute
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Matthias Behrends, MD University of California
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02623361    
Other Study ID Numbers: FICB for hip athroscopy
First Posted: December 7, 2015    Key Record Dates
Results First Posted: July 5, 2018
Last Update Posted: December 27, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes