Phase 4
N=160
Management of Postoperative Pain After Total Knee Replacement.
Postoperative Pain · Knee Replacement Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT01163214 ↗Enrolled (actual)
160
Serious AEs
2.5%
Results posted
Nov 2014
Primary outcome: Primary: Post-Operative Pain — 2.9; 3.0 units on a scale — p=0.76
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nerve Block (Drug); Periarticular Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mark J. Spangehl, M.D.
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-Operative Pain |
2.9; 3.0 | 0.76 |
| SECONDARY Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment) |
2.9; 3.1 | 0.78 |
| SECONDARY Narcotic Use |
17.4; 23.6; 4.6; 11.7; 43.0; 49.0 | <0.001 sig |
| SECONDARY Straight-leg Raise |
19; 63; 21; 63; 52; 69 | <0.001 sig |
| SECONDARY Length of Stay in Hospital |
2.84; 2.44 | 0.02 sig |
| SECONDARY Number of Subjects Who Experienced Neurological Changes Postoperatively |
1; 0; 6; 0; 2; 1 | 0.49 |
Summary
The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.
Eligibility Criteria
Inclusion Criteria
- Unilateral primary total knee replacement.
- Weight 50-125 kg.
- Age 18-79 years.
- Intact neurological exam to the surgical lower extremity.
- Cognitively intact with ability to sign informed consent.
Exclusion Criteria
- Renal insufficiency with creatinine >1.5 mg/dL.
- Allergy to medication used in the study.
- Using narcotic medication prior to surgery (morphine equivalents >=20 mg/day for >7 days.)
- Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management.
Data sourced from ClinicalTrials.gov (NCT01163214). 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.