A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy

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.

Study Overview

• Status: Completed
• Conditions: Pain; Muscle Weakness | Patient
• Intervention / Treatment: Drug: Sham Block; Drug: Peripheral Nerve Block

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Orthopedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Score	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)	within one hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg Strength at Discharge From Ambulatory Center, Surgical Leg	measurement of quadriceps strength (Force) using a dynamometer	2 hours after surgery
Patient Satisfaction	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"	48 hours

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Matthias Behrends, MD, University of California

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Actual): December 27, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: FICB for hip athroscopy