Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT02242201
Total hip arthroplasty is a one of the most commonly performed surgical procedures with increasing numbers anticipated over the next several decades. The purpose of this study was to find a better way to make patients comfortable after their hip surgery. Three different ways of providing pain relief were compared, a peripheral nerve block in the lower back outside of the spinal space (using bupivacaine, a numbing medicine), or injections around the hip joint with one of two different medicines, either Ropivacaine or Liposomal Bupivacaine (Exparel®).
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Rochester, Minnesota, 55905, United States
Total hip arthroplasty is associated with moderate to severe postoperative pain and an ideal clinical pathway for pain management has yet to be established. Multimodal pain management incorporating the use of regional anesthesia for THA has led to decreased hospital length of stay, improved patient comfort, and enhanced patient satisfaction that is efficacious and cost-effective. This investigation compared multimodal total joint arthroplasty pathways with continuous lumbar plexus blockade versus two different periarticular injection mixtures to potentially determine an ideal perioperative analgesia pathway for THA.
Patients undergoing elective, unilateral primary total hip arthroplasty within a clinical pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal analgesia were randomized to one of three different intervention groups after informed consent was obtained: posterior lumbar plexus block (PNB), periarticular infiltration (PAI) with ropivacaine, ketorolac, and epinephrine, and PAI with liposomal bupivacaine, ketorolac, and epinephrine. The investigators hypothesized differences in the analgesia outcomes between the three intervention groups would provide for an evidenced-based clinical pathway to emerge as a result of this study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Infusion
Other names: Marcaine
Injection
Other names: Naropin
Injection
Other names: Exparel
Injection, weight-based dosage of 100 mcg - 300 mcg
Injection, 30 mg
Other names: Acuvail, Acular
Time frame: Post-Operative Day 1 (0600-1200)
Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.
Time frame: Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2
Measured in daily oral morphine equivalents (OME)
Time frame: Post-operative Day 1 through discharge (approximately 3 days)
Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.
Time frame: Baseline, 3 months
Length of time in seconds a patient could stand on involved leg
Time frame: 3 month follow-up
Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.
Time frame: Baseline, 3 months
Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
Time frame: Baseline, 3 months
Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
Time frame: Post-operative Day 1 Through 3 - Month Follow-up
Complications were collected by telephone interview after surgery.
Time frame: 3 month follow up
Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.
Mayo Clinic
Other
Prospective, Randomized Controlled Trial Comparing Continuous Posterior Lumbar Plexus Nerve Block vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel®) on Patients Undergoing Total Hip Arthroplasty
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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