Knee OsteoarthritisNCT03733509
Intraoperative Direct vs Postoperative Ultrasound Guided Adductor Canal Nerve Block After Total Knee Arthroplasty
A study testing Intraoperative Block and Ultrasound Block in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
This study compares analgesic effect between two techniques of adductor canal nerve block after total knee arthroplasty. The first group of the patients will receive intraoperative adductor canal nerve block; and the other group post operative ultrasound guided adductor canal nerve block. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty, Nerve Block
- What is being tested?
- Intraoperative Block and Ultrasound 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
- 121 participants
- Where
- 1 siteChile
- Study dates
- 12 Nov 2018to 24 Oct 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary total knee arthroplasty
- Unilateral
- American Society of Anesthesiologists (ASA) score I, II or III
- Accepts spinal anesthesia
Who cannot join
- General anesthesia
- Chronic kidney disease
- Drug or alcohol abuse
- Chronic opioid use
- Allergic to bupivacaine or similar
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, 8330024
About this study
Official title: Intraoperative Direct Adductor Canal Nerve Block Versus Post Operative Ultrasound Guided Adductor Canal Nerve Block in Total Knee Arthroplasty: a Double-blind Randomized Trial
This study compares analgesic effect between two techniques of adductor canal nerve block after total knee arthroplasty. The first group of the patients will receive intraoperative adductor canal nerve block; and the other group post operative ultrasound guided adductor canal nerve block. Investigators will measure postoperative opioid consumption, pain management and rehabilitation goals.
Read the detailed description
Total knee arthroplasty (TKA) is a successful alternative to treat late stage knee osteoarthritis (OA). Pain management has been one of the main focuses of postoperative care. Most surgeons prefer a comprehensive multimodal approach including preoperative pharmacological treatment, intraoperative infiltration with complex drug mixes and postoperative peripheral nerve block.
The most common postoperative nerve block alternative is the proximal femoral nerve block (FNB) which has shown improvements on postoperative pain measured by reduced opioid consumption and decreased pain at rest. Its main detractors argue that the motor nerve block effect is deleterious to early ambulation and have promoted adductor canal nerve blocks (ACB). Described by Lund et al in 2011, ACB block main femoral pain sensory contributors to the knee (articular branches of obturator nerve, vastus medialis branch and saphenous nerve) but is more distal to most motor branches to the quadriceps allowing near to normal quadriceps strength.
Standard ACB block is performed under ultrasound guidance after surgery completion, still in the operating room (OR). Recent literature has shown the anatomic feasibility of intraoperative ACB via blunt suprapatellar dissection in standard medial parapatellar TKA approaches. The study seeks to determine the effectiveness of standard ultrasound guidance ACB compared with intraoperative ACB.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty, Nerve Block
- Being tested
- Intraoperative Block, Ultrasound Block, Intraoperative Placebo, Ultrasound Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative BlockProcedure or surgery
One shot adductor canal nerve block with 20ml of bupivacaine 0.25% through surgical incision
Ultrasound BlockProcedure or surgery
One shot adductor canal nerve block with 20ml of bupivacaine 0.25% mid-thigh
Intraoperative PlaceboProcedure or surgery
One shot adductor canal nerve infusion with 20ml of saline solution through surgical incision
Ultrasound PlaceboProcedure or surgery
One shot adductor canal nerve infusion with 20ml of saline solution mid-thigh
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Block | Experimental | Before skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of Bupivacaine 0.25%.
Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml of saline solution (NaCl 0.9%). Receives: Procedure: Intraoperative Block; Procedure: Ultrasound Placebo |
| Ultrasound Block | Active comparator | Before skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of of saline solution (NaCl 0.9%).
Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml Bupivacaine 0.25%. Receives: Procedure: Ultrasound Block; Procedure: Intraoperative Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour opioid consumption
Opioid consumption by patient controlled analgesia (PCA) and any other oral or IV analgesics
Measured: First 24 hours after surgery
Secondary outcomes (4)
24 patient reported pain
Patient reported pain scale using visual analog scale (VAS) every 6 hours after surgery (0 hours, 6 hours, 12 hours, 18 hours and 24 hours)
Measured: First 24 hours after surgery
Time up and go Test
Standardised test to determine patients ability to walk 24 hours after surgery
Measured: 24 hours after surgery
Time to Discharge
Time between surgery and patient in conditions for discharge: no IV requirements, basic walking capability and VAS pain score equal or below 3
Measured: 7 days
Range of motion
Active and passive knee range of motion
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start12 Nov 2018
- Primary completion12 May 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Model description
- Two arm, randomly assigned
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo Besa, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733509
- Sponsor's protocol ID
- 180620002
- Status last verified
- Oct 2022
- First submitted
- 6 Nov 2018
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Direct Adductor Canal Nerve Block Versus Post Operative Ultrasound Guided Adductor Canal Nerve Block in Total Knee Arthroplasty: a Double-blind Randomized Trial
- ClinicalTrials.gov ID
- NCT03733509
- Acronym / sponsor ID
- 180620002
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty, Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 7 Nov 2018 (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 compares analgesic effect between two techniques of adductor canal nerve block after total knee arthroplasty. The first group of the patients will receive intraoperative adductor canal nerve block; and the other group post operative ultrasound guided adductor canal nerve block. Investigators will measure postoperative opioid consumption, pain management and rehabilitation goals.
Detailed description
Total knee arthroplasty (TKA) is a successful alternative to treat late stage knee osteoarthritis (OA). Pain management has been one of the main focuses of postoperative care. Most surgeons prefer a comprehensive multimodal approach including preoperative pharmacological treatment, intraoperative infiltration with complex drug mixes and postoperative peripheral nerve block.
The most common postoperative nerve block alternative is the proximal femoral nerve block (FNB) which has shown improvements on postoperative pain measured by reduced opioid consumption and decreased pain at rest. Its main detractors argue that the motor nerve block effect is deleterious to early ambulation and have promoted adductor canal nerve blocks (ACB). Described by Lund et al in 2011, ACB block main femoral pain sensory contributors to the knee (articular branches of obturator nerve, vastus medialis branch and saphenous nerve) but is more distal to most motor branches to the quadriceps allowing near to normal quadriceps strength.
Standard ACB block is performed under ultrasound guidance after surgery completion, still in the operating room (OR). Recent literature has shown the anatomic feasibility of intraoperative ACB via blunt suprapatellar dissection in standard medial parapatellar TKA approaches. The study seeks to determine the effectiveness of standard ultrasound guidance ACB compared with intraoperative ACB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm, randomly assigned
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Block | Experimental | Procedure: Intraoperative Block, Procedure: Ultrasound PlaceboBefore skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of Bupivacaine 0.25%. Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml of saline solution (NaCl 0.9%). |
| Ultrasound Block | Active comparator | Procedure: Ultrasound Block, Procedure: Intraoperative PlaceboBefore skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of of saline solution (NaCl 0.9%). Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml Bupivacaine 0.25%. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary total knee arthroplasty
- Unilateral
- American Society of Anesthesiologists (ASA) score I, II or III
- Accepts spinal anesthesia
Key exclusion criteria (5 listed)
- General anesthesia
- Chronic kidney disease
- Drug or alcohol abuse
- Chronic opioid use
- Allergic to bupivacaine or similar
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 |
|---|---|---|
| Intraoperative BlockOne shot adductor canal nerve block with 20ml of bupivacaine 0.25% through surgical incision | Procedure or surgery | Intraoperative Block |
| Ultrasound BlockOne shot adductor canal nerve block with 20ml of bupivacaine 0.25% mid-thigh | Procedure or surgery | Ultrasound Block |
| Intraoperative PlaceboOne shot adductor canal nerve infusion with 20ml of saline solution through surgical incision | Procedure or surgery | Ultrasound Block |
| Ultrasound PlaceboOne shot adductor canal nerve infusion with 20ml of saline solution mid-thigh | Procedure or surgery | Intraoperative Block |
Primary outcome
24 hour opioid consumption
Time frame: First 24 hours after surgery
Opioid consumption by patient controlled analgesia (PCA) and any other oral or IV analgesics
4 secondary outcomes
24 patient reported pain
Time frame: First 24 hours after surgery
Time up and go Test
Time frame: 24 hours after surgery
Time to Discharge
Time frame: 7 days
Range of motion
Time frame: 24 hours after surgery
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 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Pablo Besa principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Block and Ultrasound Block in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 5 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 26 Oct 2022. 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 Chile. 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. 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?
24 hour opioid consumption (time frame: First 24 hours after surgery). 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 26 Oct 2022.