Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Arthroplasty

Degenerative Joint Disease Clinical Trial

— DA THA pain  

Official title:

Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Replacement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02904993
• Other study ID #: 16-001154
• Status: Terminated
• Phase: N/A
• First received: May 16, 2016
• Last updated: November 15, 2016
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To compare two methods of post-operative pain management in patients undergoing total hip arthroplasty. There is a perception that the periarticular injections may not be as effective in controlling post-operative pain.

Both methods are current standard of care. The investigators want to compare the outcomes of each when patients are randomized to one of the methods compared to the other method of post-operative pain control.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject scheduled for Direct Anterior unilateral total hip replacement

• Weight = 50 and =125 kg

• Intact neurological exam

• Cognitively intact with ability to sign consent

Exclusion Criteria:

• Renal insufficiency with creatinine > 1.5 mg/dl

• Allergic to any of the following : Ropivacaine, Epinephrine, Ketorolac, Morphine sulfate, NSAIDs, Tylenol, Neurontin, Morphine, Oxycodone or Dilaudid.

• Subject taking regular narcotic medications prior to surgery (20mg/day Morphine equivalents for >7days)

• Subject with prior open hip surgery who received regional anesthesia or periarticular injection for post op pain management.

• Subject with contraindication for spinal anesthesia

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis
• Pain, Postoperative

Intervention

Other:
• L2 paravertebral block
nerve block group will receive preoperatively a L2 paravertebral block with indwelling catheter
• periarticular injection group
periarticular injection group will receive the injection cocktail towards the end of the total hip replacement prior to skin closure.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pain score	Static and dynamic post-operative pain scores, measured on a 1 - 10 visual analogue scale.	post-operative to 7 days	Yes