Post Operative PainNCT05613101
ESPB and ACB in Knee Arthroplasty
A study testing Erector Spinae Plane Block and Adductor Canal Block in people with Post Operative Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty surgery is preferred in the treatment of osteoarthritis and causes severe postoperative pain. In this study, we aimed to investigate the effects of lumbar erector spina plan block and adductor canal block on postoperative pain and quadriceps muscle strength in patients who underwent total knee… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Erector Spinae Plane Block and Adductor Canal Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2021to 30 Aug 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who underwent total knee arthroplasty surgery
- ASA I-III patients
Who cannot join
- Patients with coagulopathy
- Patients history with local anesthetic allergy or toxicity
- Patients with long hospital stay
- Patients with advanced organ failure
- Mental retarded patients
- Presence of infection at the injection site
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Goztepe Suleyman Yalcın City Hospital
Istanbul
About this study
Official title: Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Adductor Canal Block on Postoperative Pain, Opioid Consumption and Quadriceps Muscle Strength in Total Knee Arthroplasty Surgery
Total knee arthroplasty surgery is preferred in the treatment of osteoarthritis and causes severe postoperative pain. In this study, we aimed to investigate the effects of lumbar erector spina plan block and adductor canal block on postoperative pain and quadriceps muscle strength in patients who underwent total knee arthroplasty with spinal anesthesia.
Read the detailed description
In a prospective, randomized study; Medeniyet University Faculty of Medicine Göztepe Prof. Dr. Forty patients who underwent total knee arthroplasty surgery at Süleyman Yalçın City Hospital were divided into two groups. After the surgery was completed, erector spina plane block was applied to Group E (n=20) patients with 20 ml of 0.25% bupivacaine from the operated side L3-L4 level, while in Group A (n=20) patients, in the area where the sartorius muscle crosses the adductor magnus muscle, it was lateral to the superficial femoral artery. Adductor canal block was applied to the adductor canal with 20 ml of 0.5% bupivacaine. All patients were administered 1 gr paracetamol and 75 mg diclofenac sodium when their pain started in the orthopedic ward. Numerical pain score and quadriceps muscle strength were evaluated during the 48-hour follow-up of the patients. When the pain score was 4 and above, 50 mg pethidine hydrochloride was administered.
- Conditions
- Post Operative Pain
- Being tested
- Erector Spinae Plane Block, Adductor Canal Block
- Keywords
- Erector Spinae Plane Block, Adductor Canal Block, Total Knee Arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
After the necessary asepsis and antisepsis procedures, the linear ultrasound probe was placed parasagittally 2-3 cm lateral to the spinous process at the L3 or L4 level and the transverse process was visualized. The peripheral block needle (85 mm B Braun Stimuplex A) was advanced in plane up to the transverse process and 10 ml 0.5% bupivacaine hydrochloride 10 ml 0.9% isotonic NaCl mixture was applied on the erector spina muscle.
Adductor Canal BlockProcedure or surgery
After the necessary asepsis and antisepsis procedures, the linear ultrasound probe was placed in the middle between the medial condyle and the SIAS, and the superficial femoral artery (FSA) was visualized under the sartorius muscle. By following the FSA distally, the point where the sartorius muscle crosses the adductor magnus muscle, which is the beginning of the adductor canal, was found and the saphenous nerve was visualized hyperechoic in the anterolateral aspect of the FSA. 20 cc 0.5% bupivacaine hydrochloride was applied
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Erector Spina Plane Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain. Receives: Procedure: Erector Spinae Plane Block |
| Adductor Canal Block | Active comparator | Adductor Canal Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain. Receives: Procedure: Adductor Canal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain 30 minute
Visual anolog score (1-10)
Measured: 30. min.
Postoperative pain 1. hour
Visual anolog score (1-10)
Measured: 1. hour
Postoperative pain 2. hour
Visual anolog score (1-10)
Measured: 2. hour
Postoperative pain 6. hour
Visual anolog score (1-10)
Measured: 6. hour
Postoperative pain 12. hour
Visual anolog score (1-10)
Measured: 12. hour
Postoperative pain 24. hour
Visual anolog score (1-10)
Measured: 24. hour
Postoperative pain 36. hour
Visual anolog score (1-10)
Measured: 36. hour
Postoperative pain 48. hour
Visual anolog score (1-10)
Measured: 48. hour
Secondary outcomes (8)
Opioid consuption 30. min.
Petidine (mg)
Measured: 30. min.
Opioid consuption 1. hour
Petidine (mg)
Measured: 1. hour
Opioid consuption 2. hour
Petidine (mg)
Measured: 2. hour
Opioid consuption 6. hour
Petidine (mg)
Measured: 6. hour
Opioid consuption 12. hour
Petidine (mg)
Measured: 12. hour
Opioid consuption 24. hour
Petidine (mg)
Measured: 24. hour
Opioid consuption 36. hour
Petidine (mg)
Measured: 36. hour
Opioid consuption 48. hour
Petidine (mg)
Measured: 48. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start15 Dec 2021
- Primary completion15 Jun 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Erector Plane Block Adductor Canal Block
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnal Bensu Arıoglu, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613101
- Sponsor's protocol ID
- IstanbulMUG
- Status last verified
- Nov 2022
- First submitted
- 6 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Adductor Canal Block on Postoperative Pain, Opioid Consumption and Quadriceps Muscle Strength in Total Knee Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT05613101
- Acronym / sponsor ID
- IstanbulMUG
- Conditions
- Post Operative Pain
- Keywords
- Erector Spinae Plane Block, Adductor Canal Block, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 14 Nov 2022 (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 preferred in the treatment of osteoarthritis and causes severe postoperative pain. In this study, we aimed to investigate the effects of lumbar erector spina plan block and adductor canal block on postoperative pain and quadriceps muscle strength in patients who underwent total knee arthroplasty with spinal anesthesia.
Detailed description
In a prospective, randomized study; Medeniyet University Faculty of Medicine Göztepe Prof. Dr. Forty patients who underwent total knee arthroplasty surgery at Süleyman Yalçın City Hospital were divided into two groups. After the surgery was completed, erector spina plane block was applied to Group E (n=20) patients with 20 ml of 0.25% bupivacaine from the operated side L3-L4 level, while in Group A (n=20) patients, in the area where the sartorius muscle crosses the adductor magnus muscle, it was lateral to the superficial femoral artery. Adductor canal block was applied to the adductor canal with 20 ml of 0.5% bupivacaine. All patients were administered 1 gr paracetamol and 75 mg diclofenac sodium when their pain started in the orthopedic ward. Numerical pain score and quadriceps muscle strength were evaluated during the 48-hour follow-up of the patients. When the pain score was 4 and above, 50 mg pethidine hydrochloride was administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Erector Plane Block Adductor Canal Block
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane BlockErector Spina Plane Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain. |
| Adductor Canal Block | Active comparator | Procedure: Adductor Canal BlockAdductor Canal Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who underwent total knee arthroplasty surgery
- ASA I-III patients
Key exclusion criteria (6 listed)
- Patients with coagulopathy
- Patients history with local anesthetic allergy or toxicity
- Patients with long hospital stay
- Patients with advanced organ failure
- Mental retarded patients
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 |
|---|---|---|
| Erector Spinae Plane BlockAfter the necessary asepsis and antisepsis procedures, the linear ultrasound probe was placed parasagittally 2-3 cm lateral to the spinous process at the L3 or L4 level and the transverse process was visualized. The peripheral block needle (85 mm B Braun Stimuplex A) was advanced in plane up to the transverse process and 10 ml 0.5% bupivacaine hydrochloride 10 ml 0.9% isotonic NaCl mixture was applied on the erector spina muscle. | Procedure or surgery | Erector Spinae Plane Block |
| Adductor Canal BlockAfter the necessary asepsis and antisepsis procedures, the linear ultrasound probe was placed in the middle between the medial condyle and the SIAS, and the superficial femoral artery (FSA) was visualized under the sartorius muscle. By following the FSA distally, the point where the sartorius muscle crosses the adductor magnus muscle, which is the beginning of the adductor canal, was found and the saphenous nerve was visualized hyperechoic in the anterolateral aspect of the FSA. 20 cc 0.5% bupivacaine hydrochloride was applied | Procedure or surgery | Adductor Canal Block |
Primary outcome
Postoperative pain 30 minute
Time frame: 30. min.
Visual anolog score (1-10)
Postoperative pain 1. hour
Time frame: 1. hour
Visual anolog score (1-10)
Postoperative pain 2. hour
Time frame: 2. hour
Visual anolog score (1-10)
Postoperative pain 6. hour
Time frame: 6. hour
Visual anolog score (1-10)
Postoperative pain 12. hour
Time frame: 12. hour
Visual anolog score (1-10)
Postoperative pain 24. hour
Time frame: 24. hour
Visual anolog score (1-10)
Postoperative pain 36. hour
Time frame: 36. hour
Visual anolog score (1-10)
Postoperative pain 48. hour
Time frame: 48. hour
Visual anolog score (1-10)
8 secondary outcomes
Opioid consuption 30. min.
Time frame: 30. min.
Opioid consuption 1. hour
Time frame: 1. hour
Opioid consuption 2. hour
Time frame: 2. hour
Opioid consuption 6. hour
Time frame: 6. hour
Opioid consuption 12. hour
Time frame: 12. hour
Opioid consuption 24. hour
Time frame: 24. hour
Opioid consuption 36. hour
Time frame: 36. hour
Opioid consuption 48. hour
Time frame: 48. 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 14 Nov 2022.
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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 Erector Spinae Plane Block and Adductor Canal Block in people with Post Operative Pain, run by Istanbul Medeniyet University 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 2 inclusion and 6 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 14 Nov 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 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 pain 30 minute (time frame: 30. min.). The study lists 8 primary outcomes in all. 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 14 Nov 2022.