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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Popliteal Nerve Block Foot Surgery Ankle Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.5% Injectable Solution

Intervention Type DRUG

Participants will receive the nerve block preoperatively using 0.5% ropivacaine

Ropivacaine 0.25% Injectable Solution

Intervention Type DRUG

Participants will receive the nerve block preoperatively using 0.25% ropivacaine

Percocet Pill

Intervention Type DRUG

After surgery participants will be given a prescription for Percocet to be taken as needed for pain

Norco Pill

Intervention Type DRUG

After surgery participants will be given a prescription for Norco to be taken as needed for pain

Foot/Ankle Surgery

Intervention Type PROCEDURE

Participant will undergo foot or ankle surgery and receive a popliteal nerve block

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

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.25% Injectable Solution

Intervention Type DRUG

Participants will receive the nerve block preoperatively using 0.25% ropivacaine

Percocet Pill

Intervention Type DRUG

After surgery participants will be given a prescription for Percocet to be taken as needed for pain

Norco Pill

Intervention Type DRUG

After surgery participants will be given a prescription for Norco to be taken as needed for pain

Foot/Ankle Surgery

Intervention Type PROCEDURE

Participant will undergo foot or ankle surgery and receive a popliteal nerve block

Interventions

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Ropivacaine 0.5% Injectable Solution

Participants will receive the nerve block preoperatively using 0.5% ropivacaine

Intervention Type DRUG

Ropivacaine 0.25% Injectable Solution

Participants will receive the nerve block preoperatively using 0.25% ropivacaine

Intervention Type DRUG

Percocet Pill

After surgery participants will be given a prescription for Percocet to be taken as needed for pain

Intervention Type DRUG

Norco Pill

After surgery participants will be given a prescription for Norco to be taken as needed for pain

Intervention Type DRUG

Foot/Ankle Surgery

Participant will undergo foot or ankle surgery and receive a popliteal nerve block

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes