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Trial record 8 of 1621 for:    "Mayo Clinic" [Exact]

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
John M. Redmond, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02904993
First received: May 16, 2016
Last updated: September 13, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention
Degenerative Joint Disease
Other: L2 paravertebral block
Other: periarticular injection group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Changes in pain score [ Time Frame: post-operative to 7 days ] [ Designated as safety issue: Yes ]
    Static and dynamic post-operative pain scores, measured on a 1 - 10 visual analogue scale.


Estimated Enrollment: 150
Study Start Date: May 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
L2 paravertebral block
regional anesthetic nerve blocks using an L2 paravertebral block with ropivacaine
Other: L2 paravertebral block
nerve block group will receive preoperatively a L2 paravertebral block with indwelling catheter
Active Comparator: periarticular injection group
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
periarticular injection group will receive the injection cocktail towards the end of the total hip replacement prior to skin closure.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02904993

Locations
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: John M Redmond Mayo Clinic
  More Information

Responsible Party: John M. Redmond, M.D., Orthopedic Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02904993     History of Changes
Other Study ID Numbers: 16-001154 
Study First Received: May 16, 2016
Last Updated: September 13, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Pain, Postoperative
Osteoarthritis
Joint Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016