Local Infiltration Analgesia for Hip Arthroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT01454518
First received: October 6, 2011
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to examine if ultrasound guided infiltration of local anesthetic solution around the hip joint will provide effective pain control after hip arthroscopy.


Condition Intervention
Pain
Procedure: Infiltration of local anesthetic
Procedure: Normal Saline Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effectiveness of Ultrasound Guided Hip Infiltration With Local Anesthetic Solution for Pain Control After Hip Arthroscopy

Further study details as provided by Saint Francis Care:

Primary Outcome Measures:
  • Post operative opioid consumption. [ Time Frame: Within 24 hours after surgery ] [ Designated as safety issue: No ]
    Amount in milligrams of opioid consumption post surgery in the recovery room and for a 24 hour period.


Secondary Outcome Measures:
  • Pain scores in recovery room. [ Time Frame: Within 24 hours of the surgery ] [ Designated as safety issue: No ]
    Mesures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 24 hour period after discharge from recovery room.


Enrollment: 36
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infiltration of local anesthetic
30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
Procedure: Infiltration of local anesthetic
30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
Placebo Comparator: Normal Saline Injection
injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
Procedure: Normal Saline Injection
injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hip arthroscopy
  • ages 18-80

Exclusion Criteria:

  • history of neurological disease
  • diabetes
  • pregnancy
  • neuropathy
  • chronic narcotic use
  • allergy to local anesthetic solution
  • inability to give consent or cooperate with the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454518

Locations
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Saint Francis Care
Investigators
Principal Investigator: Sanjay Sinha, M.D. Saint Francis Memorial Hospital
  More Information

No publications provided

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01454518     History of Changes
Other Study ID Numbers: 11-08-003
Study First Received: October 6, 2011
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Francis Care:
hip arthroscopy
post operative analgesia

Additional relevant MeSH terms:
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014