- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03864588
Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist
March 4, 2019 updated by: Rothman Institute Orthopaedics
A Randomized Controlled Trial Comparing Intraoperative Surgeon-Performed Versus Anesthesiologist-Performed Adductor Canal Blockade After Primary Total Knee Arthroplasty
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
164
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Rothman Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Anesthesiologist preforms ultrasound guided adductor canal block post-operatively
|
For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.
|
Experimental: Intervention
Surgeon preforms inter-operative adductor canal block
|
For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in visual analog scale pain score
Time Frame: Up to 6 weeks post-surgery
|
The primary end point is the patients' reported visual analogue pain score (VAS).
0-100mm scale
|
Up to 6 weeks post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in range of motion
Time Frame: up to 6 weeks post-surgery
|
Range of motion
|
up to 6 weeks post-surgery
|
Change in timed up and go
Time Frame: up to 6 weeks post-surgery
|
Timed up and go
|
up to 6 weeks post-surgery
|
Change in daily opioid consumption
Time Frame: up to 6 weeks post-surgery
|
daily opioid consumption
|
up to 6 weeks post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
October 26, 2018
First Submitted That Met QC Criteria
March 4, 2019
First Posted (Actual)
March 6, 2019
Study Record Updates
Last Update Posted (Actual)
March 6, 2019
Last Update Submitted That Met QC Criteria
March 4, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018LonnerSS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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