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Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

Primary Purpose

Pain, Postoperative, Satisfaction

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Anesthesiologist preforms ultrasound guided adductor canal block post-operatively

Surgeon preforms inter-operative adductor canal block

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in range of motion
Range of motion
Change in timed up and go
Timed up and go
Change in daily opioid consumption
daily opioid consumption

Full Information

First Posted
October 26, 2018
Last Updated
March 4, 2019
Sponsor
Rothman Institute Orthopaedics
Collaborators
Sharpe-Strumia Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03864588
Brief Title
Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist
Official Title
A Randomized Controlled Trial Comparing Intraoperative Surgeon-Performed Versus Anesthesiologist-Performed Adductor Canal Blockade After Primary Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
Collaborators
Sharpe-Strumia Research Foundation

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Anesthesiologist preforms ultrasound guided adductor canal block post-operatively
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Surgeon preforms inter-operative adductor canal block
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.
Primary Outcome Measure Information:
Title
Change in visual analog scale pain score
Description
The primary end point is the patients' reported visual analogue pain score (VAS). 0-100mm scale
Time Frame
Up to 6 weeks post-surgery
Secondary Outcome Measure Information:
Title
Change in range of motion
Description
Range of motion
Time Frame
up to 6 weeks post-surgery
Title
Change in timed up and go
Description
Timed up and go
Time Frame
up to 6 weeks post-surgery
Title
Change in daily opioid consumption
Description
daily opioid consumption
Time Frame
up to 6 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

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