Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

NCT ID: NCT03864588

Last Updated: 2019-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-09-30

Brief Summary

The purpose of this study is to evaluate the efficacy of two methods of administering an adductor canal block (ACB) following total knee arthroplasty (TKA); intraoperative surgeon performed intra-articular adductor canal block (IACB) and anesthesiologist ultrasound guided ADC in the post-anesthesia recovery unit (PACU).

Conditions

Pain, Postoperative; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Anesthesiologist preforms ultrasound guided adductor canal block post-operatively

Group Type: PLACEBO_COMPARATOR

Ropivacaine

Intervention Type: DRUG

For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.

Intervention

Surgeon preforms inter-operative adductor canal block

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.

Interventions

Ropivacaine

For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis
• ASA I - III
• Spinal anesthesia
• All patients will have cemented total knee utilizing a medial parapatellar approach with posterior stabilized or cruciate retaining implants. A tourniquet will be used in all cases.
• Patients must be between 18 and 80 years of age.
• Active and valid email address for the participant.

Exclusion Criteria

• Allergy to anesthetics or study analgesic medications.
• Contraindication to regional anesthesia
• Non-english speaking
• ASA IV or greater
• Renal insufficiency with Cr > 2.0 or hepatic failure
• General or epidural anesthesia
• Sensory/motor disorder involving the operative limb
• Patients who consume preoperative opioids for pain control.
• Pregnant women
• Mentally disabled patients and patients with psychiatric disorders that would prevent them from properly understanding and evaluating an informed consent process.
• Prisoners

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sharpe-Strumia Research Foundation

OTHER

Sponsor Role: collaborator

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rothman Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2018LonnerSS

Identifier Type: -

Identifier Source: org_study_id