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

NCT04872322 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2021-05-04

No results posted yet for this study

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.

Conditions

  • Popliteal Nerve Block
  • Foot Surgery
  • Ankle Surgery

Interventions

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04872322 on ClinicalTrials.gov