Regional Anesthesia in Hip Arthroscopy

Femoroacetabular Impingement Clinical Trial

Official title:

Use of Regional Anesthesia in Hip Arthroscopy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02674113
• Other study ID #: 1211908
• Status: Withdrawn
• Phase: N/A
• First received: November 7, 2015
• Last updated: February 9, 2017
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: February 2017
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to determine differences in outcomes in patients who receive regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.

Description:

Methods: After informed consent is obtained at a routine/pre-surgical clinic visit, all patients who meet eligibility criteria will undergo randomization into one of two groups. These groups are 1) to receive regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy, or 2) undergo a subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) instead of bupivacaine. Intra-operatively, both groups will receive general anesthesia and local anesthesia (lidocaine and bupivacaine in the peripheral compartment).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patient undergoing primary hip arthroscopy with labral repair and osteoplasty for hip impingement

• Age 18-45 years old

• Not pregnant

• No history of neuropathic pain

• No radiographic signs of osteoarthritis of the operative hip (Tönnisgrade 1)

• Willing and able to comply with post-operative hip arthroscopy protocol

• No documented allergy to anesthetic agents

• Able to attend follow up appointments

Exclusion Criteria:

• Allergy to regional anesthetic

• Age <18 or >45 years

• Pregnant females

• History of neuropathic pain

• Radiographic signs of osteoarthritis (Tönnis grade 2)

• Unable to speak/understand English

• Currently imprisoned

• Unwilling/unable to provide consent

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Drug:
• regional anesthesia bupivacaine
a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy
• regional anesthesia placebo
subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)

Locations

Country	Name	City	State
United States	University of Missouri Health System	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject log to record number of pain pills taken by subject for 7 days	A log that is used by the subject to record how many oral pain medications they take for 7 days.	7 days
Secondary	Record of Pain Medication given in PACU	Record narcotic requirements in PACU	immediately post-op (while in PACU, on average 1-4 hours total)
Secondary	Harris Hip score	Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.	6 weeks
Secondary	Visual analog pain scale	Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.	6 weeks
Secondary	iHOT-12 (international hip outcome tool)	Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.	6 weeks
Secondary	HOOS (hip disability and osteoarthritis outcome score)	Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.	6 weeks
Secondary	Duration of time in PACU		immediately post-op, on average between 1-4 hours
Secondary	Reported Falls Post-op		Time inpatient, on average 12-48 hours
Secondary	Unplanned admissions and/or readmissions	number of unplanned admissions/readmission	6 weeks
Secondary	Days until starting rehabilitation		immediately post-op, on average 24 hours - 2 weeks
Secondary	Patient satisfaction		6 weeks