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

Foot Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04872322
• Other study ID #: SRAI17D.481
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: August 31, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 128
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Surgery
• Foot Surgery
• Popliteal Nerve Block

Intervention

Drug:
• Ropivacaine 0.5% Injectable Solution
Participants will receive the nerve block preoperatively using 0.5% ropivacaine
• Ropivacaine 0.25% Injectable Solution
Participants will receive the nerve block preoperatively using 0.25% ropivacaine
• Percocet Pill
After surgery participants will be given a prescription for Percocet to be taken as needed for pain
• 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

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

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