Bunion Clinical Trial
Official title:
Does Ketorolac Delay Bone Healing and Improve Post-operative Pain?: A Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial
This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days) plus standard of care or placebo plus standard of care. The purpose of this study is to evaluate the effects of ketorolac plus standard of care on post-operative pain control and radiographic osseous healing. Patients will be assessed for pain via a validated pain questionnaire and for delayed unions via a radiographic scoring system shown to have both high inter- and intra-observer reliability by a blinded board certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated including adverse events and time to regular shoe gear and activities.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01435577 -
Intravenous Tapentadol in Post-Bunionectomy Pain
|
Phase 2 | |
| Active, not recruiting |
NCT05082012 -
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
|
N/A | |
| Terminated |
NCT03257540 -
Early Weight-Bearing After Lapidus Arthrodesis
|
||
| Completed |
NCT04518462 -
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
|
Phase 3 | |
| Completed |
NCT04084262 -
Multi-Plane Hallux Valgus Correction With the Phantom® Nail
|
||
| Active, not recruiting |
NCT03740282 -
Early Weight-Bearing After the Lapiplasty Procedure
|
N/A | |
| Completed |
NCT01743625 -
Safety and Efficacy Study of COV155 for Post-operative Bunionectomy Pain
|
Phase 3 | |
| Completed |
NCT01484652 -
Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension
|
Phase 3 | |
| Recruiting |
NCT05831449 -
CPL-01 in the Management of Postoperative Pain After Bunionectomy
|
Phase 3 | |
| Completed |
NCT04826328 -
Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy
|
Phase 1 | |
| Recruiting |
NCT05773846 -
A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain
|
Phase 3 | |
| Completed |
NCT03653429 -
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
|
Phase 4 | |
| Recruiting |
NCT04751344 -
Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery
|
Phase 4 | |
| Withdrawn |
NCT03954639 -
Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries
|
Phase 3 | |
| Completed |
NCT04002089 -
Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In Popliteal Fossa), for Postsurgical Analgesia in Subjects Undergoing Bunionectomy
|
Phase 1 | |
| Terminated |
NCT02499575 -
Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
|
N/A | |
| Completed |
NCT00613938 -
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
|
Phase 3 | |
| Completed |
NCT03246971 -
Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain
|
Phase 2 | |
| Completed |
NCT00890682 -
Study of Postoperative Analgesia in Bunionectomy
|
Phase 3 | |
| Active, not recruiting |
NCT05602844 -
Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus
|
N/A |