Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

Phase 4

• Conditions: Satisfaction; Pain, Postoperative
• Interventions: Drug: Ropivacaine

• Registration Number: NCT03864588
• Lead Sponsor: Rothman Institute Orthopaedics

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-26
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-04
• Study First Posted: 2019-03-06
• Last Update Posted: 2019-03-06
• Primary Completion: 2019-06
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Ropivacaine	Surgeon preforms inter-operative adductor canal block
Control	Ropivacaine	Anesthesiologist preforms ultrasound guided adductor canal block post-operatively

Primary Outcome Measures

Name	Time	Method
Change in visual analog scale pain score	Up to 6 weeks post-surgery	The primary end point is the patients' reported visual analogue pain score (VAS). 0-100mm scale

Secondary Outcome Measures

Name	Time	Method
Change in daily opioid consumption	up to 6 weeks post-surgery	daily opioid consumption
Change in range of motion	up to 6 weeks post-surgery	Range of motion
Change in timed up and go	up to 6 weeks post-surgery	Timed up and go

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States