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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02365961
Other study ID # Pro00038232
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2015
Est. completion date June 2017

Study information

Verified date February 2019
Source The Hawkins Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Scheduled for outpatient hip arthroscopy

- American Society of Anesthesiologists (ASA) 1-3

Exclusion Criteria:

- Prior surgery on ipsilateral hip

- ASA 4-6

- Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day

- Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes

- Allergy to amide local anesthetics

- Contraindication to regional anesthesia

- BMI > 40

- Females who are pregnant or plan to get pregnant during the course of the study

Study Design


Intervention

Drug:
ropivicaine

clonidine

Epinephrine

Noropin


Locations

Country Name City State
United States Steadman Hawkins Clinic of the Carolinas - Greenville Health System Greenville South Carolina

Sponsors (1)

Lead Sponsor Collaborator
The Hawkins Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Time in PACU Measured time subjects spent in the post anesthesia care unit. Duration of PACU stay in minutes from end of surgery to discharge from PACA
Other Total Number of Episodes of Nausea and Vomiting Occurrences of periods of nausea and vomiting From end of surgery to discharge from PACU
Other Hospital Readmission Number of participants that were readmitted to the hospital 3 months
Primary Visual Analog Scale Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale. 3 Months
Secondary Opioid Consumption Opioid consumption, as measured by narcotic usage (morphine milligram equivalents) 3 Months
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