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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01454518
Other study ID # 11-08-003
Secondary ID
Status Completed
Phase N/A
First received October 6, 2011
Last updated March 8, 2013
Start date October 2011
Est. completion date February 2013

Study information

Verified date March 2013
Source Saint Francis Care
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 2013
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Infiltration of local anesthetic
30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
Normal Saline Injection
injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.

Locations

Country Name City State
United States Saint Francis Hospital and Medical Center Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Saint Francis Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post operative opioid consumption. Amount in milligrams of opioid consumption post surgery in the recovery room and for a 24 hour period. Within 24 hours after surgery No
Secondary Pain scores in recovery room. 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. Within 24 hours of the surgery No
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