Adductor Canal BlockPhase 2/3NCT04968392
Single-shot Adductor Canal Block With Levobupivacaine and Dexmedetomidine in Total Knee Arthroplasty
A Phase 2/3 study testing Dexmedetomidine Hydrochloride and Levobupivacaine in people with Adductor Canal Block and Levobupivacaine, run by Assiut University at 1 site in Egypt.
Trial summary
Total knee arthroplasty surgery is associated with severe postoperative pain and adequate pain management is necessary for early postoperative mobilization and rehabilitation. Although good postoperative pain control may be achieved by continuous epidural anesthesia or femoral nerve block, both methods have adverse… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Adductor Canal Block, Levobupivacaine, Dexmedetomidine
- What is being tested?
- Dexmedetomidine Hydrochloride and Levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 May 2020
- Phase
- Phase 2/3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I or II
- undergoing elective primary total knee arthroplasty surgery under spinal anesthesia.
Who cannot join
- Patients with a known history of significant hepatic,
- renal, heart disease, autoimmune disease,
- any known convulsive disorder, any psychiatric disorders, chronic pain,
- pregnant females, regular use analgesics, anti-depressants, or opioids in the previous 2 months, revision surgery, morbid obesity, allergy to local anesthetics or morphine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Single-shot Adductor Canal Block With Levobupivacaine and Dexmedetomidine in Total Knee Arthroplasty: a Randomized Clinical Trial
Total knee arthroplasty surgery is associated with severe postoperative pain and adequate pain management is necessary for early postoperative mobilization and rehabilitation. Although good postoperative pain control may be achieved by continuous epidural anesthesia or femoral nerve block, both methods have adverse effects such as muscle weakness, which may delay postoperative mobilization.
Read the detailed description
The adductor canal block (ACB) is a relatively new block providing analgesia for knee surgery, which not only blocks the largest sensory branch of the femoral nerve but also results in less reduction of quadriceps muscle strength, compared with the femoral nerve block (FNB) in adult patients.
Randomized controlled trials have revealed that ACB provides at least equal analgesia as FNB, preserves quadriceps muscle strength better than FNB, and thus allowing for functional recovery within the first 24-hour post-TKA. However, one important limitation of single-shot peripheral nerve block is the short duration of analgesia. Because the average duration of severe pain after TKA takes 2-3 days, a continuous ACB via catheter would seem to be a good choice. Unfortunately, perineural catheters may be technically difficult to insert, are prone to premature dislodgement, and may increase infection risk. There also were some case reports of local anesthetic-induced myotoxicity after continuous ACB.
- Conditions
- Adductor Canal Block, Levobupivacaine, Dexmedetomidine
- Being tested
- Dexmedetomidine Hydrochloride, Levobupivacaine
- Keywords
- Dexmedetomidine, levobupivacaine, Adductor Canal Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine
LevobupivacaineDrug
20 mL of 0.25% levobupivacaine plus 1 mL normal saline
| Study group | Role | What they receive |
|---|---|---|
| L group | Experimental | 20 mL of 0.25% levobupivacaine plus 1 mL normal saline Receives: Drug: Levobupivacaine |
| LD group | Experimental | 20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine Receives: Drug: Dexmedetomidine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
the first analgesia rescue call.
time to the first analgesic request.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Mar 2019
- Primary completion1 Feb 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adductor Canal BlockStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968392
- Sponsor's protocol ID
- 17300626
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bauer MC, Pogatzki-Zahn EM, Zahn PK. Regional analgesia techniques for total knee replacement. Curr Opin Anaesthesiol. 2014 Oct;27(5):501-6. doi: 10.1097/ACO.0000000000000115.
PubMed 25111605Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.
PubMed 25386752Jiang X, Wang QQ, Wu CA, Tian W. Analgesic Efficacy of Adductor Canal Block in Total Knee Arthroplasty: A Meta-analysis and Systematic Review. Orthop Surg. 2016 Aug;8(3):294-300. doi: 10.1111/os.12268.
PubMed 27627711
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Single-shot Adductor Canal Block With Levobupivacaine and Dexmedetomidine in Total Knee Arthroplasty: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04968392
- Acronym / sponsor ID
- 17300626
- Conditions
- Adductor Canal Block, Levobupivacaine, Dexmedetomidine
- Keywords
- Dexmedetomidine, levobupivacaine, Adductor Canal Block
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 20 Jul 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.
Total knee arthroplasty surgery is associated with severe postoperative pain and adequate pain management is necessary for early postoperative mobilization and rehabilitation. Although good postoperative pain control may be achieved by continuous epidural anesthesia or femoral nerve block, both methods have adverse effects such as muscle weakness, which may delay postoperative mobilization.
Detailed description
The adductor canal block (ACB) is a relatively new block providing analgesia for knee surgery, which not only blocks the largest sensory branch of the femoral nerve but also results in less reduction of quadriceps muscle strength, compared with the femoral nerve block (FNB) in adult patients.
Randomized controlled trials have revealed that ACB provides at least equal analgesia as FNB, preserves quadriceps muscle strength better than FNB, and thus allowing for functional recovery within the first 24-hour post-TKA. However, one important limitation of single-shot peripheral nerve block is the short duration of analgesia. Because the average duration of severe pain after TKA takes 2-3 days, a continuous ACB via catheter would seem to be a good choice. Unfortunately, perineural catheters may be technically difficult to insert, are prone to premature dislodgement, and may increase infection risk. There also were some case reports of local anesthetic-induced myotoxicity after continuous ACB.
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 |
|---|---|---|
| L group | Experimental | Drug: Levobupivacaine20 mL of 0.25% levobupivacaine plus 1 mL normal saline |
| LD group | Experimental | Drug: Dexmedetomidine Hydrochloride20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status I or II
- undergoing elective primary total knee arthroplasty surgery under spinal anesthesia.
Key exclusion criteria (4 listed)
- Patients with a known history of significant hepatic,
- renal, heart disease, autoimmune disease,
- any known convulsive disorder, any psychiatric disorders, chronic pain,
- pregnant females, regular use analgesics, anti-depressants, or opioids in the previous 2 months, revision surgery, morbid obesity, allergy to local anesthetics or morphine
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 |
|---|---|---|
| Dexmedetomidine Hydrochloride20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine | Drug | LD group |
| Levobupivacaine20 mL of 0.25% levobupivacaine plus 1 mL normal saline | Drug | L group |
Primary outcome
the first analgesia rescue call.
Time frame: 24 hours postoperative
time to the first analgesic request.
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 20 Jul 2021.
- Background: PubMed 25111605Bauer MC, Pogatzki-Zahn EM, Zahn PK. Regional analgesia techniques for total knee replacement. Curr Opin Anaesthesiol. 2014 Oct;27(5):501-6. doi: 10.1097/ACO.0000000000000115.
- Background: PubMed 25386752Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.
- Background: PubMed 27627711Jiang X, Wang QQ, Wu CA, Tian W. Analgesic Efficacy of Adductor Canal Block in Total Knee Arthroplasty: A Meta-analysis and Systematic Review. Orthop Surg. 2016 Aug;8(3):294-300. doi: 10.1111/os.12268.
- Individual participant dataSharing planned: No
Related trials for Adductor Canal Block
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Not yet recruiting
GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty
Arthroplasty, Replacement, Knee, Pain, Postoperative
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
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 Phase 2/3 study testing Dexmedetomidine Hydrochloride and Levobupivacaine in people with Adductor Canal Block and Levobupivacaine, run by Assiut University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 20 Jul 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 first analgesia rescue call. (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04968392, which also lists 3 linked publications.
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 20 Jul 2021.