Acute PainACBNCT04883034
Adductor Canal Block in Outpatient Clinic for Pain Control After Knee Arthroplasty
A study testing adductor canal block in outpatient clinic and Analgesics, etoricoxibe in people with Acute Pain and Total Knee Arthroplasty, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
Single-shot Adductor Canal Block in the outpatient clinic is safe, significantly decreased pain and analgesic consumption and may enhance the rehabilitation program Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Total Knee Arthroplasty
- What is being tested?
- adductor canal block in outpatient clinic and Analgesics, etoricoxibe
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Declined to complete the study
- Unable to cooperate
- had an allergic reaction to any of the drugs
- abusing alcohol or drugs
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Sholahuddin Rhatomy
Sleman, Special Region of Yogyakarta, 55281
sholahuddin rhatomy, Dr, +6281808720707, sholahuddin.rhatomy@ugm.ac.id
About this study
Official title: 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
Read the 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.
- Conditions
- Acute Pain, Total Knee Arthroplasty
- Being tested
- adductor canal block in outpatient clinic, Analgesics, etoricoxibe
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adductor canal block in outpatient clinicProcedure or surgery
perform adductor canal block in outpatient clinic for patient post total knee arthroplasty
Analgesics, etoricoxibeDrug
Also called etoricoxibe
anaelgetic oral intake
| Study group | Role | What they receive |
|---|---|---|
| pain management post total knee arthroplasty with analgetic oral | Placebo comparator | 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. Receives: Drug: Analgesics, etoricoxibe |
| pain management post total knee arthroplasty with adductor canal block | Active comparator | On postoperative day 14 (POD 14), the ACB was performed for ACB group Receives: Procedure: adductor canal block in outpatient clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog pain score (VAS)
A VAS scale was used to assess pain severity, with 0 indicating no pain and 10 indicating extreme pain
Measured: one month
Secondary outcomes (1)
analgesic oral intake (etoricoxibe)
determine how much analgesic (etoricoxibe) was consumed on a daily basis.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sholahuddin Rhatomy, Gadjah Mada University
- Investigators
- sholahuddin rhatomy, dr, Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883034
- Sponsor's protocol ID
- ACB OUTPATIENT CLINIC
- Acronym
- ACB
- Status last verified
- May 2021
- First submitted
- 30 Apr 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block in Outpatient Clinic
- ClinicalTrials.gov ID
- NCT04883034
- Acronym / sponsor ID
- ACB / ACB OUTPATIENT CLINIC
- Conditions
- Acute Pain, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pain management post total knee arthroplasty with analgetic oral | Placebo comparator | Drug: Analgesics, etoricoxibePatients 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. |
| pain management post total knee arthroplasty with adductor canal block | Active comparator | Procedure: adductor canal block in outpatient clinicOn postoperative day 14 (POD 14), the ACB was performed for ACB group |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Declined to complete the study
- Unable to cooperate
- had an allergic reaction to any of the drugs
- abusing alcohol or drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adductor canal block in outpatient clinicperform adductor canal block in outpatient clinic for patient post total knee arthroplasty | Procedure or surgery | pain management post total knee arthroplasty with adductor canal block |
| Analgesics, etoricoxibeAlso: etoricoxibeanaelgetic oral intake | Drug | pain management post total knee arthroplasty with analgetic oral |
Primary outcome
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
1 secondary outcome
analgesic oral intake (etoricoxibe)
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sholahuddin rhatomy, dr principal investigator
Gadjah Mada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adductor canal block in outpatient clinic and Analgesics, etoricoxibe in people with Acute Pain and Total Knee Arthroplasty, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sholahuddin rhatomy, Dr (+6281808720707, sholahuddin.rhatomy@ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog pain score (VAS) (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.