Back to resultsAdductor Canal Block in Outpatient Clinic for Pain Control After Knee Arthroplasty (ACB)
Primary Purpose
Acute Pain, Total Knee Arthroplasty
Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
adductor canal block in outpatient clinic
Analgesics, etoricoxibe
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Inclusion Criteria:
- Indonesian or Javanese-speaking adults
- After perfomed total knee replacement
- American Society of Anesthesiologists physical status I-III
- body mass index (BMI) of 18-40 kg/m2
Exclusion Criteria:
- Declined to complete the study
- Unable to cooperate
- had an allergic reaction to any of the drugs
- abusing alcohol or drugs
Sites / Locations
- Sholahuddin RhatomyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
pain management post total knee arthroplasty with analgetic oral
pain management post total knee arthroplasty with adductor canal block
Arm Description
Patients in control group were given analgesic (etoricoxibe) on a daily basis, with the option to increase the dose if pain persisted, up to a maximum of 120 mg per day.
On postoperative day 14 (POD 14), the ACB was performed for ACB group
Outcomes
Primary Outcome Measures
Visual analog pain score (VAS)
A VAS scale was used to assess pain severity, with 0 indicating no pain and 10 indicating extreme pain
Secondary Outcome Measures
analgesic oral intake (etoricoxibe)
determine how much analgesic (etoricoxibe) was consumed on a daily basis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04883034
Brief Title
Adductor Canal Block in Outpatient Clinic for Pain Control After Knee Arthroplasty
Acronym
ACB
Official Title
Adductor Canal Block in Outpatient Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gadjah Mada University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Single-shot Adductor Canal Block in the outpatient clinic is safe, significantly decreased pain and analgesic consumption and may enhance the rehabilitation program
Detailed Description
The ACB in the outpatient clinic is safe and can minimize postoperative pain. The primary goal of this research was to see how ACB affected the Visual Analog Score (VAS) pain score during the rehabilitation as opposed to controls. The secondary goal was to determine how much analgesic (etoricoxibe) was consumed on a daily basis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Total Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pain management post total knee arthroplasty with analgetic oral
Arm Type
Placebo Comparator
Arm Description
Patients in control group were given analgesic (etoricoxibe) on a daily basis, with the option to increase the dose if pain persisted, up to a maximum of 120 mg per day.
Arm Title
pain management post total knee arthroplasty with adductor canal block
Arm Type
Active Comparator
Arm Description
On postoperative day 14 (POD 14), the ACB was performed for ACB group
Intervention Type
Procedure
Intervention Name(s)
adductor canal block in outpatient clinic
Intervention Description
perform adductor canal block in outpatient clinic for patient post total knee arthroplasty
Intervention Type
Drug
Intervention Name(s)
Analgesics, etoricoxibe
Other Intervention Name(s)
etoricoxibe
Intervention Description
anaelgetic oral intake
Primary Outcome Measure Information:
Title
Visual analog pain score (VAS)
Description
A VAS scale was used to assess pain severity, with 0 indicating no pain and 10 indicating extreme pain
Time Frame
one month
Secondary Outcome Measure Information:
Title
analgesic oral intake (etoricoxibe)
Description
determine how much analgesic (etoricoxibe) was consumed on a daily basis.
Time Frame
one month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Indonesian or Javanese-speaking adults
After perfomed total knee replacement
American Society of Anesthesiologists physical status I-III
body mass index (BMI) of 18-40 kg/m2
Exclusion Criteria:
Declined to complete the study
Unable to cooperate
had an allergic reaction to any of the drugs
abusing alcohol or drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sholahuddin rhatomy, Dr
Phone
+6281808720707
Email
sholahuddin.rhatomy@ugm.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sholahuddin rhatomy, dr
Organizational Affiliation
Gadjah Mada University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sholahuddin Rhatomy
City
Sleman
State/Province
Yogyakarta
ZIP/Postal Code
55281
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sholahuddin rhatomy, Dr
Phone
+6281808720707
Email
sholahuddin.rhatomy@ugm.ac.id
12. IPD Sharing Statement
Learn more about this trial
Adductor Canal Block in Outpatient Clinic for Pain Control After Knee Arthroplasty
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