Phase 4
N=67
The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00620828 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Numeric Pain Score — 0.67; 1.6; 2.5; 3.6 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo saline injection (Other); Ropivicaine 0.5% (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Pain Score |
0.67; 1.6; 2.5; 3.6; 3.8; 4.9 | <0.05 sig |
| SECONDARY Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption |
22.4; 43.7; 95.6; 126.6; 173.4; 205.6 | .05 |
| SECONDARY Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance |
38.4; 26.4 | .05 |
| SECONDARY Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion |
7.8; 7.0; 71.5; 69.6 | .05 |
| SECONDARY Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise |
4; 5; 13; 5; 12; 5 | .05 |
Summary
The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
Eligibility Criteria
Inclusion Criteria
- The subject is scheduled to undergo elective total knee replacement at Duke University Hospital.
- The subject has signed the written consent form.
Exclusion Criteria
- Known allergy to ropivacaine or hydromorphone.
- Known history of narcotic abuse or alcohol abuse.
- Known history of chronic pain.
- Known diagnosis of peripheral neuropathy or complex regional pain syndrome.
- Significant impediment to physical therapy participation.
- The surgery is a revision case.
- Patient is undergoing bilateral Total Knee Replacement.
Data sourced from ClinicalTrials.gov (NCT00620828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.