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

Phase 3

• Conditions: Popliteal Nerve Block; Foot Surgery; Ankle Surgery
• Interventions: Drug: Ropivacaine 0.25% Injectable Solution; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Percocet Pill; Drug: Norco Pill; Procedure: Foot/Ankle Surgery

• Registration Number: NCT04872322
• Lead Sponsor: Rothman Institute Orthopaedics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• All patients undergoing foot and ankle surgeries under the care of Dr. Steven Raikin with continuous popliteal blocks at Riverview Surgical Center will be considered for enrollment.

Exclusion Criteria

• Patients who present with a) known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type,
• Existing use of narcotics,
• Pregnant women,
• Individuals under the age of 18
• Procedures involving any other forms of anesthesia other than general anesthesia with a continuous popliteal nerve block.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Popliteal Nerve Block	Percocet Pill	Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine.
Partial Popliteal Nerve Block	Percocet Pill	Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery
Standard Popliteal Nerve Block	Norco Pill	Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine.
Partial Popliteal Nerve Block	Ropivacaine 0.25% Injectable Solution	Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery
Partial Popliteal Nerve Block	Norco Pill	Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery
Standard Popliteal Nerve Block	Ropivacaine 0.5% Injectable Solution	Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine.
Standard Popliteal Nerve Block	Ropivacaine 0.25% Injectable Solution	Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine.
Standard Popliteal Nerve Block	Foot/Ankle Surgery	Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine.
Partial Popliteal Nerve Block	Foot/Ankle Surgery	Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	7 days	Participants Satisfaction with pain control will be measured using the Visual Analog Scale for Pain (VAS)
Postoperative Opioid Usage	7 days	For each group, participants will be asked to record their postoperative pain medication usage daily

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States