Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Unknown status

CT.gov ID

NCT03864588

Collaborator

Sharpe-Strumia Research Foundation (Other)

164

Enrollment

Location

Arms

Anticipated Duration (Months)

14.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Satisfaction	Drug: Ropivacaine	Phase 4

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2018

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
Change in daily opioid consumption [up to 6 weeks post-surgery]
daily opioid consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics
Sharpe-Strumia Research Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT03864588

Other Study ID Numbers:

2018LonnerSS

First Posted:

Mar 6, 2019

Last Update Posted:

Mar 6, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pain, Postoperative

Ropivacaine

Study Results

No Results Posted as of Mar 6, 2019