A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy

NCT02623361 | Completed Phase 4 Results DMC

• 1 other identifier: FICB for hip athroscopy
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness | Patient; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Leg Strength at Discharge From Ambulatory Center, Surgical Leg

  2 hours after surgery

• Patient Satisfaction

  48 hours

Study Arms (2)

Sham

PLACEBO COMPARATOR

Drug: Sham Block

Fascia Iliaca Compartment Block

ACTIVE COMPARATOR

Drug: Peripheral Nerve Block

Interventions

Peripheral Nerve Block DRUG

Regional Anesthesia by Local Anesthetic Injection

Fascia Iliaca Compartment Block

Sham Block DRUG

Sham Block by saline injection

Sham

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Orthopedic Institute

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Matthias Behrends, PI
• Organization: UCSF

matthias.behrends@ucsf.edu

415 476 3761

Study Officials

• Matthias Behrends, MD

  University of California

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 7, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 27, 2018
• Results First Posted: July 5, 2018

Record last verified: 2018-12

Locations

US (1)