Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

NCT03864588 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2018LonnerSS
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in visual analog scale pain score

  The primary end point is the patients' reported visual analogue pain score (VAS). 0-100mm scale

  Up to 6 weeks post-surgery

Secondary Outcomes (3)

• Change in range of motion

  up to 6 weeks post-surgery

• Change in timed up and go

  up to 6 weeks post-surgery

• Change in daily opioid consumption

  up to 6 weeks post-surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

Anesthesiologist preforms ultrasound guided adductor canal block post-operatively

Drug: Ropivacaine

Intervention

EXPERIMENTAL

Surgeon preforms inter-operative adductor canal block

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead
• Sharpe-Strumia Research Foundation: collaborator

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Personal Satisfaction

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: March 6, 2019
• Study Start: October 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

US (1)