- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04883034
Adductor Canal Block in Outpatient Clinic for Pain Control After Knee Arthroplasty (ACB)
May 6, 2021 updated by: Sholahuddin Rhatomy, Gadjah Mada University
Adductor Canal Block in Outpatient Clinic
Single-shot Adductor Canal Block in the outpatient clinic is safe, significantly decreased pain and analgesic consumption and may enhance the rehabilitation program
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: sholahuddin rhatomy, Dr
- Phone Number: +6281808720707
- Email: sholahuddin.rhatomy@ugm.ac.id
Study Locations
-
-
Yogyakarta
-
Sleman, Yogyakarta, Indonesia, 55281
- Recruiting
- Sholahuddin Rhatomy
-
Contact:
- sholahuddin rhatomy, Dr
- Phone Number: +6281808720707
- Email: sholahuddin.rhatomy@ugm.ac.id
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: pain management post total knee arthroplasty with analgetic oral
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.
|
anaelgetic oral intake
Other Names:
|
Active Comparator: pain management post total knee arthroplasty with adductor canal block
On postoperative day 14 (POD 14), the ACB was performed for ACB group
|
perform adductor canal block in outpatient clinic for patient post total knee arthroplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog pain score (VAS)
Time Frame: one month
|
A VAS scale was used to assess pain severity, with 0 indicating no pain and 10 indicating extreme pain
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
analgesic oral intake (etoricoxibe)
Time Frame: one month
|
determine how much analgesic (etoricoxibe) was consumed on a daily basis.
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: sholahuddin rhatomy, dr, Gadjah Mada University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
April 30, 2021
First Submitted That Met QC Criteria
May 6, 2021
First Posted (Actual)
May 12, 2021
Study Record Updates
Last Update Posted (Actual)
May 12, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACB OUTPATIENT CLINIC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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