Total Knee ArthroplastyNCT04400708
Single-injection Adductor Canal Block for Total Knee Arthroplasty Under Spinal Anesthesia
A study testing adductor canal block in people with Total Knee Arthroplasty, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- adductor canal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2020to 29 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients receiving total-knee arthroplasty under spinal anesthesia
- ASA class 1-3
Who cannot join
- infection at the needle injection site
- hard for pain evaluation
- CRPS patient with lower extremity symptom
- chronic opioid user
- those with side effect to local anesthetics
- those getting revision total-knee arthroplasty or with the previous operation at the same knee area
- those getting the surgery under general anesthesia due to the failed spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Postoperative Single-injection Adductor Canal Block for Multimodal Pain Control in Patients Receiving Total Knee Arthroplasty Under Spinal Anesthesia
This study evaluates the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia.
Read the detailed description
This study aims to evaluate the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia. The effect of the single-injection adductor canal and continuous adductor canal block in patients receiving total knee arthroplasty under general anesthesia has been well established. However, due to the residual effect of spinal anesthesia, the effect of the single-injection adductor canal block needs to be determined. The investigators hypothesize that the single-injection adductor canal block will decrease the total sum of 2h, 6h, 12h, and 24h pain score.
- Conditions
- Total Knee Arthroplasty
- Being tested
- adductor canal block, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adductor canal blockProcedure or surgery
After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of 0.5% ropivacaine 15ml is given.
control groupProcedure or surgery
After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of normal saline15ml is given.
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | normal saline injection Receives: Procedure: control group |
| test group | Experimental | 0.5% ropivacaine injection Receives: Procedure: adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sum of pain score
VAS pain score (0 to 10) is measured using numeric pain rating scale at 2 hours, 6 hours, 12 hours, and 24 hours 0: no pain, 10: worst pain
Measured: 2 hours, 6 hours, 12 hours, and 24 hours after intervention
Secondary outcomes (2)
Postoperative nausea and vomiting
degree of postoperative nausea and vomiting (0 to 3) 0: no nausea, no vomiting, 1: nausea present, but no vomiting, 2: nausea present, vomiting once, 3: vomiting repeatedly within 30 minutes.
Measured: 2 hours, 6 hours, 12 hours, and 24 hours after intervention
Postoperative opioid consumption
amount of postoperative opioid consumption based on oral morphine equivalent daily dose
Measured: 2 hours, 6 hours, 12 hours, and 24 hours intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start28 May 2020
- Primary completion22 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400708
- Sponsor's protocol ID
- 2004-253-11
- Status last verified
- Nov 2023
- First submitted
- 19 May 2020
- Last updated
- 24 Nov 2023
- 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postoperative Single-injection Adductor Canal Block for Multimodal Pain Control in Patients Receiving Total Knee Arthroplasty Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04400708
- Acronym / sponsor ID
- 2004-253-11
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 22 May 2020 (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.
This study evaluates the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia.
Detailed description
This study aims to evaluate the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia. The effect of the single-injection adductor canal and continuous adductor canal block in patients receiving total knee arthroplasty under general anesthesia has been well established. However, due to the residual effect of spinal anesthesia, the effect of the single-injection adductor canal block needs to be determined. The investigators hypothesize that the single-injection adductor canal block will decrease the total sum of 2h, 6h, 12h, and 24h pain score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Procedure: control groupnormal saline injection |
| test group | Experimental | Procedure: adductor canal block0.5% ropivacaine injection |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients receiving total-knee arthroplasty under spinal anesthesia
- ASA class 1-3
Key exclusion criteria (7 listed)
- infection at the needle injection site
- hard for pain evaluation
- CRPS patient with lower extremity symptom
- chronic opioid user
- those with side effect to local anesthetics
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 blockAfter the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of 0.5% ropivacaine 15ml is given. | Procedure or surgery | test group |
| control groupAfter the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of normal saline15ml is given. | Procedure or surgery | control group |
Primary outcome
the sum of pain score
Time frame: 2 hours, 6 hours, 12 hours, and 24 hours after intervention
VAS pain score (0 to 10) is measured using numeric pain rating scale at 2 hours, 6 hours, 12 hours, and 24 hours 0: no pain, 10: worst pain
2 secondary outcomes
Postoperative nausea and vomiting
Time frame: 2 hours, 6 hours, 12 hours, and 24 hours after intervention
Postoperative opioid consumption
Time frame: 2 hours, 6 hours, 12 hours, and 24 hours intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
Related trials for Total Knee Arthroplasty
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
Anxiety, Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 people with Total Knee Arthroplasty, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 24 Nov 2023. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sum of pain score (time frame: 2 hours, 6 hours, 12 hours, and 24 hours after intervention). 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 24 Nov 2023.