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

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04872322

Collaborator

(none)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Aug 31, 2017

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Ropivacaine

Pharmaceutical Solutions

Study Results

No Results Posted as of May 4, 2021