Recruiting

Regional Anesthesia

Sponsor:

Georgetown University

Code:

NCT02851888

Conditions

Hip Injuries

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Ropivacaine

Normal Saline Sham Injection

General Anesthesia

Study Details

Brief summary:

The purpose of this research is to determine differences in outcomes in patients who do, or do not, receive regional anesthesia (a fascia iliaca block) prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement

Conditions

Hip Injuries

Study ID

NCT02851888

Start date

Jul, 2016

Status verified date

Nov, 2017

Completion date

Aug, 2018

Anticipated

Primary completion date

Apr, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Scheduled for arthroscopic labral repair with or without osteoplasty of the hip.
  • 18 to 50 years old
  • American Society of Anesthesiologists Physical Status (ASA PS) score of I or II.

Exclusion Criteria:

  • Current or planned pregnancy
  • History of neuropathic pain, chronic pain syndrome, or preoperative use of narcotic or neuropathic pain medicine
  • Radiographic signs of osteoarthritis (> Tonis grade 1)
  • Inability to attend follow up visits
  • Documented allergy to local anesthetic

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Iliac Fascia Block (Ropivacaine)

These patients will receive a preoperative iliac fascia block performed as a single shot in the standard fashion prior to hip arthroscopy with general anesthesia.

sham comparator: Control (Normal Saline Sham Injection)

These patients will receive a preoperative sham block of normal saline in the same fashion as a standard singl shot iliac fascia block prior to hip arthroscopy with general anesthesia.

Interventions

Ropivacaine

Iliac fascia block was performed in the experimental group with a single shot of Ropavicaine.

Normal Saline Sham Injection

Sham block using normal saline instead of iliac fascia block but otherwise employing the equivalent technique.

General Anesthesia

Patients were induced and maintained in a fashion consistent with standard practices.

Primary outcome measure

  • Pain Medication Requirement in PACU [ Time Frame: 24 hours post-operatively ]

Central Contacts and Locations

Central contacts

John G Mawn, BS

2624883210jm2564@georgetown.edu

Jessica B Hawken, BA

7039949605jesshawken13@gmail.com

Locations

Georgetown University Medical Center

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

John Mawn, BS

262-488-3210jm2564@georgetown.edu

More Information

Sponsor

Georgetown University

Last update posted

Feb 19, 2018

Last verified

Nov, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Georgetown University on 2018-02-19.