Ultrasound-Guided Obturator Nerve Block for Ambulatory Hip Arthroscopy

NCT02346357 | Unknown DMC

• 1 other identifier: IRB14003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Hip arthroscopy is commonly associated with moderate-to-severe postoperative pain. The purpose of this study is to investigate the analgesic efficacy of preoperative obturator nerve block as measured by postoperative pain scores and postoperative analgesic requirements. The primary outcome will be the patient's first reported pain scores in the post anesthesia care unit (PACU).

Conditions

Pain

Keywords

hip arthroscopy; analgesia

Outcome Measures

Primary Outcomes (1)

• Immediate pain score upon arrival to phase 1 PACU (NRS pain score)

  Initial NRS pain score upon arrival in the post anesthesia cafe unit (PACU)

  Within 5-30 minutes upon leaving operating room and arrival to Phase I recovery

Secondary Outcomes (5)

• Post anesthesia care unit discharge (Time required to meet discharge criteria from phase 2 PACU)

  Wihtin 6 hours from end of surgery.

• Nausea (Number of episodes of nausea and vomiting during the 1st 24 hours postoperatively)

  1st 24 hours after surgery

• Sleep quality on on the day of surgery (Did subjects have difficulty going to sleep or wake up from sleep due to pain?)

  Within 12-24 hours after discharge to home (from the hospital); typically the same night of the day of surgery.

• Opioid (analgesic) consumption

  From the start of surgery to 24 hours after surgery complete (average surgical duration 2.5 hours).

• Pain scores for the 1st 24 hours after surgery (Numeric Rating Scale Pain)

  1st 24 hours after completion of surgery.

Study Arms (2)

Obturator nerve block

ACTIVE COMPARATOR

Ultrasound-guided single-injection obturator nerve block with 20 mL ropivacaine 0.5%

Procedure: Obturator Nerve Block; Drug: Ropivacaine

Sham block

PLACEBO COMPARATOR

Placebo arm. Ultrasound-guided injection of 3-5 mL normal saline in the subcutaneous tissue in the same location as would for an obturator nerve block.

Procedure: Obturator Nerve Block; Drug: Placebo Saline

Interventions

Obturator Nerve Block PROCEDURE

Ultrasound-guided obturator nerve block with 20 mL of treatment drug (Ropivacaine 0.5% \[local anesthetic\]) 30 minutes prior to induction of anesthesia.

Also known as: Nerve block

Obturator nerve block; Sham block

Ropivacaine DRUG

Obturator nerve block

Placebo Saline DRUG

Sham block

Eligibility Criteria

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

You may qualify if:

• Primary unilateral ambulatory hip arthroscopy
• Age 18 to 65 years
• ASA physical status I to III
• Ability to follow the protocol.

You may not qualify if:

• Age \<18 or \>65 years of age
• Contraindications to peripheral nerve blockade
• Allergy to opioids or local anesthetics
• Allergy to sulfa medications or nonsteroidal anti-inflammatory medications
• Chronic opioid
• Patient refusal

Sponsors & Collaborators

• Benaroya Research Institute: lead

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Nerve Block; Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Francis Salinas, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis Salinas, MD

CONTACT

206-223-6980; Francis.Salinas@virginiamason.org

Stan Yuan, MD

CONTACT

206-223-6980; stanley.yuan@virginiamason.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: January 27, 2015
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

US (1)