Phase 4
N=40
Genicular Nerve Block for Total Knee Arthroplasty
Post-operative Pain
Bottom Line
View on ClinicalTrials.gov: NCT03706313 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Opioid Consumption at 24 Hours Post-op — 22.9; 58.1 milligrams of oral morphine equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 15mL 0.25% bupivacaine (Drug); Genicular nerve block (Procedure); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption at 24 Hours Post-op |
22.9; 58.1 | — |
| SECONDARY Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1 |
2.7; 3.5 | — |
| SECONDARY Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1 |
4.9; 6.3 | — |
| SECONDARY Total Opioid Consumption Through 48 Hours |
50.3; 97.6 | — |
| SECONDARY Opioid Consumption on Postoperative Day 7 |
10.4; 22.6 | — |
| SECONDARY Worst Pain Rating Score (NRS-11) on Postoperative Day 7 |
4.4; 5.0 | — |
| SECONDARY Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night |
0; 1 | — |
| SECONDARY Patient Satisfaction With Pain Control at 24 h |
9.1; 8.6 | — |
| SECONDARY Patient Satisfaction With Pain Control on Postoperative Day 7 |
8.8; 8.9 | — |
| SECONDARY 20 Meter Walk Test Time Performed on Postoperative Day 1 |
74.2; 80.2 | — |
Summary
This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after total knee replacement.
Eligibility Criteria
Inclusion Criteria
- Subjects scheduled for primary elective total knee arthroplasty
- American Society of Anesthesiologists Physical Status I-III
- BMI 18-40 kg/m2
Exclusion Criteria
- Inability to cooperate with protocol
- Inability to understand or speak English
- Allergy to ropivacaine, bupivacaine or other local anesthetic
- Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
- Revision knee surgery
- Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four weeks prior to surgery)
- History of chronic pain
- History of psychiatric disorder
- History of diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT03706313). 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.