Postoperative PainNCT03188809
Adductor Canal Block Versus Femoral Nerve Block With Repeated Bolus Doses Arthroplasty
A study testing Adductor Canal Block and femoral nerve block in people with Postoperative Pain and Functional Outcomes, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
After total knee prosthesis surgery, in the first postopertive days, serious pain complaints occur in the patients and this causes many problems, especially mobility limitation. For this reason, a strong analgesic is needed. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Postoperative Pain, Functional Outcomes
- What is being tested?
- Adductor Canal Block and femoral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2017to 31 Dec 2017
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA1-2-3 patients
- older than 55 years
- who undergo elective total knee prosthesis in our hospital
Who cannot join
- ASA IV patients ,
- patients with local anesthesia that we use,
- patients with coagulation disorders,
- patients with anatomical anomalies,
- patients with localized infection in the injection site ,
- patients who is incapable of using pca and/ or evaulate VAS scale,
Show all 11Show fewer
- patients with peripheral nerve disease,
- patients with different surgical planning,
- complicated gonarthrosis patients,
- revision planned patients,
- patients who refuse to be involved in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adductor Canal Block Versus Femoral Nerve Block With Repeated Bolus Doses: Postoperative Analgesia and Functional Outcomes After Total Knee Arthroplasty
After total knee prosthesis surgery, in the first postopertive days, serious pain complaints occur in the patients and this causes many problems, especially mobility limitation. For this reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in the forefront, peripheral nerve blocks are frequently preferred due to complications related to central nerve blocks. Femoral nerve block and adductor channel block are the preferred peripheral blocks for total knee prosthesis. Since early mobilization after total hip prosthesis is very important, it is aimed to provide sufficient analgesia by making less motor block. Previous studies have shown that adductor channel block provides similar analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the risk of falls are not yet clear, although it is estimated to be in the positive direction. Again, previous studies have compared single doses and infusion doses but no repeated bolus doses. Repeated bolus doses have been shown to be more effective in studies in which adductor channel catheters have been introduced to date to compare infusion and recurrent bolus doses.
investigators aimed to compare the effects of repeated bolus doses with femoral nerve catheter and adductor channel catheter on postoperative pain and muscle strength in patients undergoing total knee replasment under spinal anesthesia in this study.
Read the detailed description
After total knee prosthesis surgery, in the first postopertive days, serious pain complaints occur in the patients and this causes many problems, especially mobility limitation. For this reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in the forefront, peripheral nerve blocks are frequently preferred due to complications related to central nerve blocks. Femoral nerve block and adductor channel block are the preferred peripheral blocks for total knee prosthesis. Since early mobilization after total hip prosthesis is very important, it is aimed to provide sufficient analgesia by making less motor block. Previous studies have shown that adductor channel block provides similar analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the risk of falls are not yet clear, although it is estimated to be in the positive direction. Again, previous studies have compared single doses and infusion doses but no repeated bolus doses. Repeated bolus doses have been shown to be more effective in studies in which adductor channel catheters have been introduced to date to compare infusion and recurrent bolus doses.
investigators aimed to compare the effects of repeated bolus doses with femoral nerve catheter and adductor channel catheter on postoperative pain and muscle strength in patients undergoing total knee revision under spinal anesthesia in this study. Materials and Methods: The patient will be informed about the procedure to be performed before the operation and written approval will be given. The patient will be premeditated with 2mg midazolam and sedayon and monitored according to routine operating room procedures and total knee prosthesis operation under spinal anesthesia. Patients will then be transferred to the collection room and ECG, NIBP and SpO2 monitoring and appropriate sterilization will be performed, and a grubby femoral nerve catheter with USG will be attached to the other group adductor channel catheter. A 20cc 0.25% marcain will be administered in 6 hours, with the first dose catheter placed in both groups.
In the compilation unit, the patient will be infused with IV PCA in the morphine. The bolus dose of 1 mg IV of the PC will be adjusted to the duration of 10 minutes of lockout. Postoperatively, 3x1 metoclopramide, 4x1 gr / 24h IV paracetamol and 3x50 mg / 24h IV dexketoprofen will be administered to each patient.
In this process, demographic information of the patients, peroperative KH, ABP, SpO2 values will be recorded. In the postoperative period, the patient's pain level, opioid requirement, motor block and muscle strength will be recorded and compared statistically.
- Conditions
- Postoperative Pain, Functional Outcomes
- Being tested
- Adductor Canal Block, femoral nerve block
- Keywords
- Postoperative Pain, Functional Outcomes, Total Knee Arthroplasty, Adductor Canal Block, Femoral Nerve Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal BlockProcedure or surgery
Also called saphen nerve block
Adductor channel is roughly triangular in cross section and is bounded by three muscles: quadriceps anterolaterally (specifically vastusmedialis), sartorius medially and adductor magnus posteriorly. Within this canal is the femoral artery, femoral vein, the posterior branch of the obturator nerve, and branches of the femoral nerve; specifically the saphenous nerve and nerve to vastus medialis. When the femoral artery is shown by ultrasonography 21 gauge, 50 mm needle in-plane technique and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
femoral nerve blockProcedure or surgery
The probe is placed just below the inguinal crease , when the femoral artery is shown by ultrasonography, the femoral nerve stays in the lateral direction and 21 gauge, 50 mm needle will be advanced from the anterior to the posteriomedial with an in-plane technique and the catheter will be inserted by the peripheral nerve stimulator in the lateral femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
| Study group | Role | What they receive |
|---|---|---|
| femoral nerve block | Active comparator | Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted. Receives: Procedure: femoral nerve block |
| adductor canal block | Active comparator | Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted. Receives: Procedure: Adductor Canal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Muscle strength- Quadriceps Muscle strength scale
Quadriceps Muscle strength scale
Measured: postoperative 48 hour
Secondary outcomes (1)
postoperative analgesia - Visual analog scale
Visual analog scale
Measured: 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start5 Apr 2017
- Primary completion30 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Model description
- double blind, randomised, controlled train
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Kurtbeyoğlu, Kecioren Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188809
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2017
- Last updated
- 19 Mar 2024
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block Versus Femoral Nerve Block With Repeated Bolus Doses: Postoperative Analgesia and Functional Outcomes After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03188809
- Acronym / sponsor ID
- 1
- Conditions
- Postoperative Pain, Functional Outcomes
- Keywords
- Postoperative Pain, Functional Outcomes, Total Knee Arthroplasty, Adductor Canal Block, Femoral Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 15 Jun 2017 (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.
After total knee prosthesis surgery, in the first postopertive days, serious pain complaints occur in the patients and this causes many problems, especially mobility limitation. For this reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in the forefront, peripheral nerve blocks are frequently preferred due to complications related to central nerve blocks. Femoral nerve block and adductor channel block are the preferred peripheral blocks for total knee prosthesis. Since early mobilization after total hip prosthesis is very important, it is aimed to provide sufficient analgesia by making less motor block. Previous studies have shown that adductor channel block provides similar analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the risk of falls are not yet clear, although it is estimated to be in the positive direction. Again, previous studies have compared single doses and infusion doses but no repeated bolus doses. Repeated bolus doses have been shown to be more effective in studies in which adductor channel catheters have been introduced to date to compare infusion and recurrent bolus doses.
investigators aimed to compare the effects of repeated bolus doses with femoral nerve catheter and adductor channel catheter on postoperative pain and muscle strength in patients undergoing total knee replasment under spinal anesthesia in this study.
Detailed description
After total knee prosthesis surgery, in the first postopertive days, serious pain complaints occur in the patients and this causes many problems, especially mobility limitation. For this reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in the forefront, peripheral nerve blocks are frequently preferred due to complications related to central nerve blocks. Femoral nerve block and adductor channel block are the preferred peripheral blocks for total knee prosthesis. Since early mobilization after total hip prosthesis is very important, it is aimed to provide sufficient analgesia by making less motor block. Previous studies have shown that adductor channel block provides similar analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the risk of falls are not yet clear, although it is estimated to be in the positive direction. Again, previous studies have compared single doses and infusion doses but no repeated bolus doses. Repeated bolus doses have been shown to be more effective in studies in which adductor channel catheters have been introduced to date to compare infusion and recurrent bolus doses.
investigators aimed to compare the effects of repeated bolus doses with femoral nerve catheter and adductor channel catheter on postoperative pain and muscle strength in patients undergoing total knee revision under spinal anesthesia in this study. Materials and Methods: The patient will be informed about the procedure to be performed before the operation and written approval will be given. The patient will be premeditated with 2mg midazolam and sedayon and monitored according to routine operating room procedures and total knee prosthesis operation under spinal anesthesia. Patients will then be transferred to the collection room and ECG, NIBP and SpO2 monitoring and appropriate sterilization will be performed, and a grubby femoral nerve catheter with USG will be attached to the other group adductor channel catheter. A 20cc 0.25% marcain will be administered in 6 hours, with the first dose catheter placed in both groups.
In the compilation unit, the patient will be infused with IV PCA in the morphine. The bolus dose of 1 mg IV of the PC will be adjusted to the duration of 10 minutes of lockout. Postoperatively, 3x1 metoclopramide, 4x1 gr / 24h IV paracetamol and 3x50 mg / 24h IV dexketoprofen will be administered to each patient.
In this process, demographic information of the patients, peroperative KH, ABP, SpO2 values will be recorded. In the postoperative period, the patient's pain level, opioid requirement, motor block and muscle strength will be recorded and compared statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind, randomised, controlled train
| Arm | Type | Receives |
|---|---|---|
| femoral nerve block | Active comparator | Procedure: femoral nerve blockBupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted. |
| adductor canal block | Active comparator | Procedure: Adductor Canal BlockBupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA1-2-3 patients
- older than 55 years
- who undergo elective total knee prosthesis in our hospital
Key exclusion criteria (11 listed)
- ASA IV patients ,
- patients with local anesthesia that we use,
- patients with coagulation disorders,
- patients with anatomical anomalies,
- patients with localized infection in the injection site ,
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 BlockAlso: saphen nerve blockAdductor channel is roughly triangular in cross section and is bounded by three muscles: quadriceps anterolaterally (specifically vastusmedialis), sartorius medially and adductor magnus posteriorly. Within this canal is the femoral artery, femoral vein, the posterior branch of the obturator nerve, and branches of the femoral nerve; specifically the saphenous nerve and nerve to vastus medialis. When the femoral artery is shown by ultrasonography 21 gauge, 50 mm needle in-plane technique and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted. | Procedure or surgery | adductor canal block |
| femoral nerve blockThe probe is placed just below the inguinal crease , when the femoral artery is shown by ultrasonography, the femoral nerve stays in the lateral direction and 21 gauge, 50 mm needle will be advanced from the anterior to the posteriomedial with an in-plane technique and the catheter will be inserted by the peripheral nerve stimulator in the lateral femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted. | Procedure or surgery | femoral nerve block |
Primary outcome
Postoperative Muscle strength- Quadriceps Muscle strength scale
Time frame: postoperative 48 hour
Quadriceps Muscle strength scale
1 secondary outcome
postoperative analgesia - Visual analog scale
Time frame: 72 hour
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 19 Mar 2024.
- 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.
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 and femoral nerve block in people with Postoperative Pain and Functional Outcomes, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 11 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 19 Mar 2024. 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 Turkey (Türkiye). 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?
Postoperative Muscle strength- Quadriceps Muscle strength scale (time frame: postoperative 48 hour). 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 19 Mar 2024.