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

Rothman Institute Orthopaedics logo

Rothman Institute Orthopaedics

Status and phase

Unknown
Phase 3

Conditions

Foot Surgery
Ankle Surgery
Popliteal Nerve Block

Treatments

Drug: Ropivacaine 0.5% Injectable Solution
Drug: Percocet Pill
Procedure: Foot/Ankle Surgery
Drug: Ropivacaine 0.25% Injectable Solution
Drug: Norco Pill

Study type

Interventional

Funder types

Other

Identifiers

NCT04872322
SRAI17D.481

Details and patient eligibility

About

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.

Enrollment

128 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

128 participants in 2 patient groups

Standard Popliteal Nerve Block
Active Comparator group
Description:
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.
Treatment:
Drug: Norco Pill
Drug: Percocet Pill
Drug: Ropivacaine 0.25% Injectable Solution
Drug: Ropivacaine 0.5% Injectable Solution
Procedure: Foot/Ankle Surgery
Partial Popliteal Nerve Block
Active Comparator group
Description:
Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery
Treatment:
Drug: Norco Pill
Drug: Percocet Pill
Drug: Ropivacaine 0.25% Injectable Solution
Procedure: Foot/Ankle Surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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