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Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block After TKA

Primary Purpose

Total Knee Arthroplasty, Osteoarthritis, Post Operative Pain Control

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
20ml bolus of 0.5% ropivicaine
0.2% Ropivicaine at 8 milliliter/hour
5ml bolus of 0.5% ropivicaine
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty focused on measuring adductor canal block, tinetti score, time to up and go test, Ambulation distance, pain score, quality of recovery score

Eligibility Criteria

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

Inclusion Criteria:

  • Patients scheduled for primary total knee arthroplasty
  • American Society of Anesthesiologists (ASA) physical status I -III
  • mentally competent and able to give consent for enrollment in the study

Exclusion Criteria:

  • Patient younger than 18 years old
  • Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3)
  • Revision surgery
  • Impaired kidney functions and patient with coagulopathy
  • Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 3 months prior to the surgery
  • BMI of 40 or more
  • Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Single shot adductor canal block

24 hour continuous adductor canal block

48 hour continuous adductor canal block

Arm Description

adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA

adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA

adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA

Outcomes

Primary Outcome Measures

Patients With Severe Pain at 48 Hours After Surgery
The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day

Secondary Outcome Measures

Pain Scores at 48 Hours After Surgery
Average pain scores 48 hours after surgery. The scale used is the numeric rating pain scale. The scale values range from 0-10/ where 0 is no pain and 10 is the worst pain possible imagined on this scale
Functional Recovery After Surgery
Cumulative ambulation distance in the second postoperative day measured in feet
Patient-oriented Outcomes
Quality of recovery (QoR)-9 score on the second day after surgery. This score is a result of a 9 item questionnaire. Answers to each item/question is scored as (0-1-2). The wort score a patient get in the questionnaire is 0 and the best score is 18, depending on the answer of each of the 9 questions and the sum of the scores of these answers

Full Information

First Posted
March 23, 2016
Last Updated
October 5, 2018
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02730728
Brief Title
Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block After TKA
Official Title
A Randomized Study of Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block for Postoperative Analgesia After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare a single shot block, 24 hours, and 48 hour continuous catheter nerve block done via the adductor canal method in adult patients who have under gone total knee arthroplasty. Visual analogue scores, opioid consumption, time to up and go, ambulation, manual muscle tests, and Tinetti scores up to 72 hours post operatively will be used for comparison.
Detailed Description
If the patient is willing to participate and signs the consent, he/she will be randomized to one of the three treatment groups: Single shot block 24 hour catheter 48 hour catheter The choice of anesthetic technique will be at the discretion of the anesthesiologist. In our institution we usually advocate for spinal anesthesia for total knee arthroplasty. All patients will receive their multimodal perioperative pain protocol (MP3) medication as per protocol in the patient receiving area (400 mg of gabapentin, 200 mg of Celecoxib, and 1gm of acetaminophen). Patients will be monitored during block performance with standard ASA monitors. All patients will be receiving 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation. Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite S nerve machine will be used with a high frequency linear (HFL) US probe with 6-13 MHZ frequency. Both single shot and continuous adductor canal block will be performed according to the standard operating practices in our department 4. Ultrasound survey at the medial part of the thigh will take place, halfway between the superior anterior iliac spine and the patella. In a short axis view, the femoral artery will be identified underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery. The needle will be introduced in-plane and 2 to 3 mL of local anesthesia bolus will be used to verify correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal. For single shot blocks: A bolus of total volume of 20 ml of ropivicaine 0.5% will be injected through the needle. For the continuous block: The catheter will be introduced and advanced 2-3 cm beyond the tip of the needle under ultrasound visualization. The needle was withdrawn over the catheter. Injection of a bolus of 5 ml of ropivacaine 0.5% will take place through the catheter while observing the spread of local anesthetic under ultrasound. The catheter hub will be affixed to the upper lateral thigh with sterile occlusive dressings and an anchoring device. Block success will be defined as a change in cutaneous sensation to touch with an alcohol pad in the saphenous nerve distribution over the medial leg within 30min after injection. Subjects with successful catheter placement per protocol and nerve block onset were retained in the study. Subjects with a failed catheter insertion or misplaced catheter indicated by a lack of sensory changes had their catheter replaced or were withdrawn from the study. At the conclusion of surgery, the catheters will be connected to a pump that will infuse local anesthetic. Ropivicaine 0.2% at 8 ml/hour. In the postoperative anesthesia care unit, intermittent boluses of hydromorphone will be used as needed. Postoperative analgesia will follow the MP3 protocol. Drugs that are used for the multimodal analgesia protocol include acetaminophen (1 gm every 8 hours for 72 hours), celecoxib (200 mg every 8 hours for 72 hours), Gabapentin (300 mg every 8 hours for one week if the patient is opioid naïve and for two weeks if patients are opioid tolerant), and oxycodone (5-10-15 mg oral as needed every 4 hours for pain based on patient reported pain score). All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during surgery. The protocol for prophylaxis against PONV include administration of 4 mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250 mg/dl.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Osteoarthritis, Post Operative Pain Control
Keywords
adductor canal block, tinetti score, time to up and go test, Ambulation distance, pain score, quality of recovery score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single shot adductor canal block
Arm Type
Active Comparator
Arm Description
adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA
Arm Title
24 hour continuous adductor canal block
Arm Type
Active Comparator
Arm Description
adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA
Arm Title
48 hour continuous adductor canal block
Arm Type
Active Comparator
Arm Description
adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA
Intervention Type
Drug
Intervention Name(s)
20ml bolus of 0.5% ropivicaine
Intervention Description
Local anesthetic
Intervention Type
Drug
Intervention Name(s)
0.2% Ropivicaine at 8 milliliter/hour
Intervention Description
Local anesthetic
Intervention Type
Drug
Intervention Name(s)
5ml bolus of 0.5% ropivicaine
Intervention Description
Local anesthetic
Primary Outcome Measure Information:
Title
Patients With Severe Pain at 48 Hours After Surgery
Description
The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain Scores at 48 Hours After Surgery
Description
Average pain scores 48 hours after surgery. The scale used is the numeric rating pain scale. The scale values range from 0-10/ where 0 is no pain and 10 is the worst pain possible imagined on this scale
Time Frame
48 hours
Title
Functional Recovery After Surgery
Description
Cumulative ambulation distance in the second postoperative day measured in feet
Time Frame
48 hours
Title
Patient-oriented Outcomes
Description
Quality of recovery (QoR)-9 score on the second day after surgery. This score is a result of a 9 item questionnaire. Answers to each item/question is scored as (0-1-2). The wort score a patient get in the questionnaire is 0 and the best score is 18, depending on the answer of each of the 9 questions and the sum of the scores of these answers
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for primary total knee arthroplasty American Society of Anesthesiologists (ASA) physical status I -III mentally competent and able to give consent for enrollment in the study Exclusion Criteria: Patient younger than 18 years old Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3) Revision surgery Impaired kidney functions and patient with coagulopathy Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 3 months prior to the surgery BMI of 40 or more Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil M Elkassabany, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block After TKA

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