Phase 4
N=115
Anterior Cruciate Ligament Pain Study
Anterior Cruciate Ligament Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT02604550 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Pain Score — 4.1; 4.0; 3.9; 5.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ropivacaine 0.5% (Drug); Percocet 7.5/325 (Drug); Naprosyn 500 mg (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score |
4.1; 4.0; 3.9; 5.1; 5.7; 5.7 | — |
| SECONDARY Number of Percocet Tablets Consumed |
2.0; 2.4; 4.6; 4.7; 3.7; 3.6 | — |
| SECONDARY Total Hours of Sleep |
6.3; 5.8 | — |
| SECONDARY Patient-Reported Nausea |
3; 2 | — |
| SECONDARY Patient-Reported Vomiting |
1; 1 | — |
| SECONDARY Patient-Reported Constipation |
2; 1 | — |
| SECONDARY Patient-Reported Sedation |
0; 0 | — |
| SECONDARY Patient-Reported Itching |
2; 1 | — |
| SECONDARY Time to Straight Less Raise |
31.7; 16.4 | — |
| SECONDARY Percent of Patients Rating Their Satisfaction as "Excellent" or "Good" |
39; 64 | — |
Summary
The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center
- Patients willing and able to provide written informed consent
- Parents willing and able to provide written informed consent for minors
Exclusion Criteria
- Patients who are pregnant or lactating
- Patients with liver dysfunction or renal failure
- Patients with a known allergy to ropivacaine
- Patients with a local infection
- Patients who take chronic pain medications
- Patients with an opioid tolerance
- Patients with known coagulopathy or bleeding risk.
- Patients who are getting neuraxial anesthesia for surgery
Data sourced from ClinicalTrials.gov (NCT02604550). 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.