NCT04872322

Effect of Ropivacaine During Popliteal Nerve Block in Foot and Ankle Surgery

Randomized Study of the Effect of Initial Ropivacaine Dosage During Continuous Popliteal Nerve Blocks on Rebound Pain in Foot and Ankle Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

With the increasing rise of outpatient surgery in orthopaedic procedures, the management of immediate postoperative pain has been a major topic investigated, with the use of a peripheral nerve block in combination with general anesthesia being a commonly accepted method. Foot and ankle procedures, which offer the choice of several anesthetic techniques, have increasingly been performed with this method predominantly through the combination of general anesthesia with a single-injection popliteal nerve block to reduce the substantial acute postoperative pain that often requires large opioid intake within the post-anesthesia care unit (PACU). However, as a single-injection peripheral nerve block resolves off shortly following surgery, major postoperative pain, termed "rebound pain", can also arise, and has the potential to be even greater than that of patients who do not receive any peripheral nerve block with general anesthesia. The purpose of this study is to evaluate the contribution of ropivacaine concentration (0.5% versus 0.25%) of the initial bolus in continuous popliteal nerve blocks toward the rebound pain phenomena, or the quantifiable difference in pain experienced during the initial time after block resolution, in foot and ankle surgeries.

Conditions

• Popliteal Nerve Block
• Foot Surgery
• Ankle Surgery

Interventions

Type	Name	Description
DRUG	Ropivacaine 0.5% Injectable Solution	Participants will receive the nerve block preoperatively using 0.5% ropivacaine
DRUG	Ropivacaine 0.25% Injectable Solution	Participants will receive the nerve block preoperatively using 0.25% ropivacaine
DRUG	Percocet Pill	After surgery participants will be given a prescription for Percocet to be taken as needed for pain
DRUG	Norco Pill	After surgery participants will be given a prescription for Norco to be taken as needed for pain
PROCEDURE	Foot/Ankle Surgery	Participant will undergo foot or ankle surgery and receive a popliteal nerve block

Timeline

• Start date: 2017-08-31
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-05-04
• Last updated: 2021-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study