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Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

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ClinicalTrials.gov Identifier: NCT03864588
Recruitment Status : Unknown
Verified March 2019 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Sharpe-Strumia Research Foundation
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Pain, Postoperative Satisfaction Drug: Ropivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Intraoperative Surgeon-Performed Versus Anesthesiologist-Performed Adductor Canal Blockade After Primary Total Knee Arthroplasty
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Anesthesiologist preforms ultrasound guided adductor canal block post-operatively
Drug: Ropivacaine
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
Drug: Ropivacaine
For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in range of motion [ Time Frame: up to 6 weeks post-surgery ]
    Range of motion

  2. Change in timed up and go [ Time Frame: up to 6 weeks post-surgery ]
    Timed up and go

  3. Change in daily opioid consumption [ Time Frame: up to 6 weeks post-surgery ]
    daily opioid consumption



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864588


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
Sharpe-Strumia Research Foundation
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03864588    
Other Study ID Numbers: 2018LonnerSS
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents