Back to resultsDaily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty
Primary Purpose
Postoperative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Single shot adductor canal block
Continuous adductor canal block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria: ASA classification I, II, III Patients scheduled for unilateral knee arthroplasty Exclusion Criteria: Anesthesia other than spinal anesthesia Chronic opioid use Uncontrolled diabetes of HbA1c>7.5 Neuromuscular pathology of the ipsilateral leg Second-look knee arthroplasty Inability to communicate (e.g. dementia) Hypersensitivity to ropivacaine BMI > 40 Pregnancy
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Single shot adductor canal block
Continuous adductor canal block
Arm Description
Outcomes
Primary Outcome Measures
Average NRS pain score at rest
average of numerical rating scale (0: no pain, 10: worst imaginable pain) pain scores from 8 time points during 48h (+4h, +8h, +12h from end of surgery, 6AM, 2PM, 10PM of postoperative day 1, and 6AM and 2PM of postoperative day 2)
Secondary Outcome Measures
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +4h from end of surgery
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +4h from end of surgery
NRS pain score at rest at +8h from end of surgery
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +8h from end of surgery
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +12h from end of surgery
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +12h from end of surgery
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 1
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 6AM on postoperative day 1
NRS pain score at rest at 2PM on postoperative day 1
NRS pain score during movement at 2PM on postoperative day 1
NRS pain score at rest at 10PM on postoperative day 1
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 10PM on postoperative day 1
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 2
NRS pain score during movement at 6AM on postoperative day 2
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 2PM on postoperative day 2
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 2PM on postoperative day 2
Posteoperative opioid administration in morphine equivalents
Incidence of catheter tip dislocation
The catheter tip is considered to be dislocated if the catheter tip is located outside the adductor canal
Incidence of extravasation from catheter insertion site
Incidence of sleep disturbance due to pain
Incidence of numbness of anterior thigh area
Strengh of quadratus femoris muscle (unit: kgf)
Incidence of falls during hospital stay
Postoperative range of motion of knee joint
Full Information
NCT ID
NCT05727137
First Posted
January 25, 2023
Last Updated
February 21, 2023
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University
1. Study Identification
Unique Protocol Identification Number
NCT05727137
Brief Title
Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty
Official Title
Analgesic Efficacy of Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will compare the analgesic efficacy of daily single-shot adductor canal block(ABC) versus continuous ACB after total knee arthroplasty (TKA).
Detailed Description
Patients 19-75 years old, of ASA classification I-III scheduled for unilateral TKA, will be enrolled and randomized into two groups, single-shot ACB group and continuous ACB group. In both groups, participants will be administered a single-shot ACB immediately after the end of the operation. The single-shot ACB group will receive two separate single-shot ACBs, on the first and second postoperative day. A nerve block catheter will be placed in patients in the continuous ACB group, which will be connected to a patient-controlled analgesia pump until the second postoperative day. The primary outcome of this study is the average NRS pain score at rest from the end of surgery to 2 days after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single shot adductor canal block
Arm Type
Experimental
Arm Title
Continuous adductor canal block
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Single shot adductor canal block
Intervention Description
Single shot adductor canal block on the the first and second postoperative day.
Intervention Type
Procedure
Intervention Name(s)
Continuous adductor canal block
Intervention Description
A catheter will be placed in the adductor canal and connected to a continuous patient-controlled analgesia pump.
Primary Outcome Measure Information:
Title
Average NRS pain score at rest
Description
average of numerical rating scale (0: no pain, 10: worst imaginable pain) pain scores from 8 time points during 48h (+4h, +8h, +12h from end of surgery, 6AM, 2PM, 10PM of postoperative day 1, and 6AM and 2PM of postoperative day 2)
Time Frame
first 48h after end of surgery
Secondary Outcome Measure Information:
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +4h from end of surgery
Time Frame
+4h from end of surgery
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +4h from end of surgery
Time Frame
+4h from end of surgery
Title
NRS pain score at rest at +8h from end of surgery
Time Frame
+8h from end of surgery
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +8h from end of surgery
Time Frame
+8h from end of surgery
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +12h from end of surgery
Time Frame
+12h from end of surgery
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +12h from end of surgery
Time Frame
+12h from end of surgery
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 1
Time Frame
6AM on postoperative day 1
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 6AM on postoperative day 1
Time Frame
6AM on postoperative day 1
Title
NRS pain score at rest at 2PM on postoperative day 1
Time Frame
2PM on postoperative day 1
Title
NRS pain score during movement at 2PM on postoperative day 1
Time Frame
2PM on postoperative day 1
Title
NRS pain score at rest at 10PM on postoperative day 1
Time Frame
10PM on postoperative day 1
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 10PM on postoperative day 1
Time Frame
10PM on postoperative day 1
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 2
Time Frame
6AM on postoperative day 2
Title
NRS pain score during movement at 6AM on postoperative day 2
Time Frame
6AM on postoperative day 2
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 2PM on postoperative day 2
Time Frame
2PM on postoperative day 2
Title
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 2PM on postoperative day 2
Time Frame
2PM on postoperative day 2
Title
Posteoperative opioid administration in morphine equivalents
Time Frame
from end of surgery to 48h after surgery
Title
Incidence of catheter tip dislocation
Description
The catheter tip is considered to be dislocated if the catheter tip is located outside the adductor canal
Time Frame
at 2PM on postoperative day 1 and 2
Title
Incidence of extravasation from catheter insertion site
Time Frame
at 2PM on postoperative day 1 and 2
Title
Incidence of sleep disturbance due to pain
Time Frame
from end of surgery to postoperative day 2
Title
Incidence of numbness of anterior thigh area
Time Frame
at 2PM on postoperative day 1 and 2
Title
Strengh of quadratus femoris muscle (unit: kgf)
Time Frame
at 2PM on postoperative day 1 and 2
Title
Incidence of falls during hospital stay
Time Frame
from end of surgery to 48h after surgery
Title
Postoperative range of motion of knee joint
Time Frame
at 2PM on postoperative day 1 and 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA classification I, II, III
Patients scheduled for unilateral knee arthroplasty
Exclusion Criteria:
Anesthesia other than spinal anesthesia
Chronic opioid use
Uncontrolled diabetes of HbA1c>7.5
Neuromuscular pathology of the ipsilateral leg
Second-look knee arthroplasty
Inability to communicate (e.g. dementia)
Hypersensitivity to ropivacaine
BMI > 40
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hansol Kim, MD
Phone
+82-10-3160-1548
Email
esquimo@seoul.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seokha Yoo, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seokha Yoo, MD
Email
muroki85@snu.ac.kr
12. IPD Sharing Statement
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Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty
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