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Adductor Canal Nerve Block Following Total Knee Arthroplasty

Primary Purpose

Post-op Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.
For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-op Pain focused on measuring Total knee arthroplasty, nerve block, Pain control after surgery

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Is the subject undergoing primary unilateral total knee arthroplasty?
  2. Is the subject 18 to 99 years of age?
  3. Is the subject ASA class 1, 2, or 3?
  4. Does the subject have a BMI less than 35?
  5. Can the subject consent in the English language?

Exclusion Criteria:

  1. Does subject have an allergy to drugs used in this study;
  2. Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone?
  3. Does subject have a history of alcohol or drug abuse
  4. Has subject had a previous total knee arthroplasty?
  5. Has subject had any neurologic deficits in the lower extremity being studied?

Sites / Locations

  • Loma Linda University Medical Center East Campus Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

15ml ropivacaine

30ml ropivacaine

Arm Description

Depending on what dose of ropivacaine the subject is randomized to he/she could receive the 15ml dose injected into the catheter every 6 hours

If the subject is randomized to 30ml ropivacaine he/she will be injected through the catheter every 6 hours.

Outcomes

Primary Outcome Measures

Total Opiate pain medication
At the end of the 48 hours period the total opiate pain medication taken will be collected and used for comparison as our primary outcome

Secondary Outcome Measures

Patient satisfaction with pain control
Secondary outcome measures will include demographic characteristics, pain scores, medication administration,patient satisfaction with pain control and any complications that may have arisen. We will also record the location of the adductor canal catheter on the final bolus dose.

Full Information

First Posted
September 3, 2013
Last Updated
April 19, 2021
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT01939379
Brief Title
Adductor Canal Nerve Block Following Total Knee Arthroplasty
Official Title
Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution. Efforts made to contact PI unsuccessful. No study data available.
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 25, 2017 (Actual)
Study Completion Date
July 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-op Pain
Keywords
Total knee arthroplasty, nerve block, Pain control after surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15ml ropivacaine
Arm Type
Active Comparator
Arm Description
Depending on what dose of ropivacaine the subject is randomized to he/she could receive the 15ml dose injected into the catheter every 6 hours
Arm Title
30ml ropivacaine
Arm Type
Active Comparator
Arm Description
If the subject is randomized to 30ml ropivacaine he/she will be injected through the catheter every 6 hours.
Intervention Type
Drug
Intervention Name(s)
Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.
Intervention Type
Drug
Intervention Name(s)
For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.
Primary Outcome Measure Information:
Title
Total Opiate pain medication
Description
At the end of the 48 hours period the total opiate pain medication taken will be collected and used for comparison as our primary outcome
Time Frame
The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery.
Secondary Outcome Measure Information:
Title
Patient satisfaction with pain control
Description
Secondary outcome measures will include demographic characteristics, pain scores, medication administration,patient satisfaction with pain control and any complications that may have arisen. We will also record the location of the adductor canal catheter on the final bolus dose.
Time Frame
We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is the subject undergoing primary unilateral total knee arthroplasty? Is the subject 18 to 99 years of age? Is the subject ASA class 1, 2, or 3? Does the subject have a BMI less than 35? Can the subject consent in the English language? Exclusion Criteria: Does subject have an allergy to drugs used in this study; Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone? Does subject have a history of alcohol or drug abuse Has subject had a previous total knee arthroplasty? Has subject had any neurologic deficits in the lower extremity being studied?
Facility Information:
Facility Name
Loma Linda University Medical Center East Campus Hospital
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

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Adductor Canal Nerve Block Following Total Knee Arthroplasty

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