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

• ClinicalTrials.gov Identifier: NCT04872322
• Recruitment Status: Enrolling by invitation
• First Posted: May 4, 2021
• Last Update Posted: May 4, 2021
• Sponsor: Rothman Institute Orthopaedics
• Information provided by (Responsible Party): Rothman Institute Orthopaedics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Popliteal Nerve Block; Foot Surgery; Ankle Surgery	Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.25% Injectable Solution; Drug: Percocet Pill; Drug: Norco Pill; Procedure: Foot/Ankle Surgery	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Study of the Effect of Initial Ropivacaine Dosage During Continuous Popliteal Nerve Blocks on Rebound Pain in Foot and Ankle Surgery
• Actual Study Start Date: August 31, 2017
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Pennsylvania

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

More Information

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT04872322
• Other Study ID Numbers: SRAI17D.481
• First Posted: May 4, 2021
• Last Update Posted: May 4, 2021
• Last Verified: May 2021

• 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

Additional relevant MeSH terms:

Ropivacaine; Pharmaceutical Solutions; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents