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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Foot Surgery; Ankle Surgery; Popliteal Nerve Block
• Intervention / Treatment: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.25% Injectable Solution; Drug: Percocet Pill; Drug: Norco Pill; Procedure: Foot/Ankle Surgery

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Popliteal Nerve Block; 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.	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
Active Comparator: Partial Popliteal Nerve Block; Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: SRAI17D.481

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes