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

NCT04872322 | Unknown Phase 3 FDA Drug

• 1 other identifier: SRAI17D.481
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Popliteal Nerve Block; Foot Surgery; Ankle Surgery

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain

  Participants Satisfaction with pain control will be measured using the Visual Analog Scale for Pain (VAS)

  7 days

• Postoperative Opioid Usage

  For each group, participants will be asked to record their postoperative pain medication usage daily

  7 days

Study Arms (2)

Standard Popliteal Nerve Block

ACTIVE COMPARATOR

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; Drug: Ropivacaine 0.25% Injectable Solution; Drug: Percocet Pill; Drug: Norco Pill; Procedure: Foot/Ankle Surgery

Partial Popliteal Nerve Block

ACTIVE COMPARATOR

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; Drug: Percocet Pill; Drug: Norco Pill; Procedure: Foot/Ankle Surgery

Interventions

Ropivacaine 0.5% Injectable Solution DRUG

Participants will receive the nerve block preoperatively using 0.5% ropivacaine

Standard Popliteal Nerve Block

Ropivacaine 0.25% Injectable Solution DRUG

Participants will receive the nerve block preoperatively using 0.25% ropivacaine

Partial Popliteal Nerve Block; Standard Popliteal Nerve Block

Percocet Pill DRUG

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

Partial Popliteal Nerve Block; Standard Popliteal Nerve Block

Norco Pill DRUG

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

Partial Popliteal Nerve Block; Standard Popliteal Nerve Block

Foot/Ankle Surgery PROCEDURE

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

Partial Popliteal Nerve Block; Standard Popliteal Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Ropivacaine; oxycodone-acetaminophen

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 4, 2021
• Study Start: August 31, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

US (1)