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

NCT02904993 | Terminated

• 1 other identifier: 16-001154
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Joint Disease

Outcome Measures

Primary Outcomes (1)

• Changes in pain score

  Static and dynamic post-operative pain scores, measured on a 1 - 10 visual analogue scale.

  post-operative to 7 days

Study Arms (2)

L2 paravertebral block

OTHER

regional anesthetic nerve blocks using an L2 paravertebral block with ropivacaine

Other: L2 paravertebral block

periarticular injection group

ACTIVE COMPARATOR

periarticular local injection into the periarticular soft tissues at the time of hip replacement using a combination of ropivacaine, epinephrine, ketorolac and morphine sulphate (periarticular injection group).

Other: periarticular injection group

Interventions

L2 paravertebral block OTHER

nerve block group will receive preoperatively a L2 paravertebral block with indwelling catheter

L2 paravertebral block

periarticular injection group OTHER

periarticular injection group will receive the injection cocktail towards the end of the total hip replacement prior to skin closure.

periarticular injection group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject scheduled for Direct Anterior unilateral total hip replacement
• Weight ≥ 50 and ≤125 kg
• Intact neurological exam
• Cognitively intact with ability to sign consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• John M Redmond

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Consultant

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: September 19, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 16, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)