Orthopedic DisorderNCT05648708
Combined Adductor&Sciatic Nerve Block vs Femoral&Sciatic Nerve Block in Total Knee Replacement Surgery
A study testing Combine Adductor Canal & Sciatic Nerve Block, Combine Femoral & Sciatic Nerve Block and Bupivacaine and prilocaine hydrochloride in people with Orthopedic Disorder and Total Knee Replacement, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Knee joints, one of the largest and most functional joints of the human body, have great features to provide ideal body posture and movement. In patients with knee osteoarthritis in whom pain and functional loss continue to increase despite conservative and medical burden, they are evaluated by orthopedic surgeons for… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Orthopedic Disorder, Total Knee Replacement, Post Operative Pain
- What is being tested?
- Combine Adductor Canal & Sciatic Nerve Block, Combine Femoral & Sciatic Nerve Block and Bupivacaine and prilocaine hydrochloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Nov 2022to 23 Oct 2023
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 40-85
- ASA I-III
- Patients who will undergo total knee replacement surgery under general anesthesia
Who cannot join
- Patients with deformity and pathology in the thigh region
- Clinically known local anesthetic allergy
- Clinically diagnosis of opioid, alcohol and substance dependence
- Patients who cannot perceive and evaluate pain such as psychiatric illness, mental retardation, dementia
- Morbid obesity (body mass index> 40 kg m2)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Bakirkoy, 34147
About this study
Official title: Comparing Combined Adductor Canal & Sciatic Nerve Block and Femoral & Sciatic Nerve Block for Postoperative Analgesia in Patients Undergoing Total Knee Replacement Surgery; A Prospective, Randomized, Controlled Study
Knee joints, one of the largest and most functional joints of the human body, have great features to provide ideal body posture and movement. In patients with knee osteoarthritis in whom pain and functional loss continue to increase despite conservative and medical burden, they are evaluated by orthopedic surgeons for surgical treatment. Total knee replacement (TKR) surgery is aimed to eliminate the existing pain, restore and carry the movements, to protect the characteristics of the deformities and the quality of life.
Pain can be very severe after TKR surgery, which is very common in the middle and elderly patient population today. In the postoperative period, untreated pain prevents early physical therapy practices and restricts postoperative knee rehabilitation and recovery, but it also has negative effects on the respiratory, gastrointestinal, renal, and central nervous systems. Effective management of postoperative acute pain can reduce these complications and the risk of developing chronic pain.
In this study, investigators hypothesized that combined adductor canal and sciatic nerve block, applied with postoperative ultrasound guidance to patients who will undergo TKR surgery under general anesthesia, will provide effective analgesia, less opioid consumption, and faster ambulation time, similar to combined femoral and sciatic nerve block.
Read the detailed description
As a result of the power analysis investigators conducted for this study, the minimum sample size was calculated as 34 people for each group, 68 people in total, at the 95% confidence interval.
68 patients who meet the inclusion criteria will be included in our study. Patients will be randomized and divided into 2 groups. Accordingly, femoral and sciatic nerve blocks will be applied to 34 patients, and adductor canal and sciatic nerve blocks will be applied to 34 patients.
- Being tested
- Combine Adductor Canal & Sciatic Nerve Block, Combine Femoral & Sciatic Nerve Block, Bupivacaine and prilocaine hydrochloride
- Keywords
- Femoral Nerve Block, Sciatic Nerve Block, Adductor Canal Block, General anesthesia, Orthopedic surgery, Post Operative Analgesia
- Medical subject headings
- Musculoskeletal Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combine Adductor Canal & Sciatic Nerve BlockProcedure or surgery
The investigators will perform a combined adductor canal \& sciatic nerve block on that patient group for postoperative analgesia
Combine Femoral & Sciatic Nerve BlockProcedure or surgery
The investigators will perform a combined femoral \& sciatic nerve block on that patient group for postoperative analgesia
Bupivacaine and prilocaine hydrochlorideDrug
The investigators will perform a combined adductor canal \& sciatic nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride
Bupivacaine and prilocaine hydrochlorideDrug
The investigators will perform a combined femoral \& sciatic nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Group AS | Active comparator | The investigators will perform an adductor canal block and sciatic nerve block on that patient group for postoperative analgesia Receives: Procedure: Combine Adductor Canal & Sciatic Nerve Block; Drug: Bupivacaine and prilocaine hydrochloride |
| Group FS | Active comparator | The investigators will perform femoral and sciatic nerve blocks on that patient group for postoperative analgesia Receives: Procedure: Combine Femoral & Sciatic Nerve Block; Drug: Bupivacaine and prilocaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of the study is the patients' postoperative pain scores (NRS)
Numerical rating scale (NRS) at 1, 6, 12, 18, 24, 48, 72th hours. NRS assessment score ranges from 0-10. 0 = no pain 10 = worst pain imaginable
Measured: 72 hours postoperatively
Secondary outcomes (1)
The secondary outcome measure will be total opioid consumption in the first 72 hours postoperatively
PCA device will be prepared with 4 mg tramadol (400 mg/100 cc) per ml and total opioid consumption for 72 hours will be noted
Measured: Three days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start14 Nov 2022
- Primary completion21 Aug 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648708
- Sponsor's protocol ID
- 2022-361
- Status last verified
- Jun 2025
- First submitted
- 28 Nov 2022
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available from the publication date can start. NRS scores and Opioid consumption and side effects will be shared. If requested, data will be shared with anesthesiologists dealing with postoperative analgesia in patients undergoing total knee replacement surgery
Publications
Auroy Y, Narchi P, Messiah A, Litt L, Rouvier B, Samii K. Serious complications related to regional anesthesia: results of a prospective survey in France. Anesthesiology. 1997 Sep;87(3):479-86. doi: 10.1097/00000542-199709000-00005.
PubMed 9316950Sladjana UZ, Ivan JD, Bratislav SD. Microanatomical structure of the human sciatic nerve. Surg Radiol Anat. 2008 Nov;30(8):619-26. doi: 10.1007/s00276-008-0386-6. Epub 2008 Jul 23.
PubMed 18648720Currin SS, Mirjalili SA, Meikle G, Stringer MD. Revisiting the surface anatomy of the sciatic nerve in the gluteal region. Clin Anat. 2015 Jan;28(1):144-9. doi: 10.1002/ca.22449. Epub 2014 Aug 8.
PubMed 25131147Bozkurt M, Yilmazlar A, Bilgen OF. [Comparing the effects of analgesia techniques with controlled intravenous and epidural on postoperative pain and knee rehabilitation after total knee arthroplasty]. Eklem Hastalik Cerrahisi. 2009;20(2):64-70. Turkish.
PubMed 19619108Gray AT, Collins AB. Ultrasound-guided saphenous nerve block. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):148; author reply 148. doi: 10.1053/rapm.2003.50000. No abstract available.
PubMed 12677627
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Combined Adductor Canal & Sciatic Nerve Block and Femoral & Sciatic Nerve Block for Postoperative Analgesia in Patients Undergoing Total Knee Replacement Surgery; A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05648708
- Acronym / sponsor ID
- 2022-361
- Keywords
- Femoral Nerve Block, Sciatic Nerve Block, Adductor Canal Block, General anesthesia, Orthopedic surgery, Post Operative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 13 Dec 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.
Knee joints, one of the largest and most functional joints of the human body, have great features to provide ideal body posture and movement. In patients with knee osteoarthritis in whom pain and functional loss continue to increase despite conservative and medical burden, they are evaluated by orthopedic surgeons for surgical treatment. Total knee replacement (TKR) surgery is aimed to eliminate the existing pain, restore and carry the movements, to protect the characteristics of the deformities and the quality of life.
Pain can be very severe after TKR surgery, which is very common in the middle and elderly patient population today. In the postoperative period, untreated pain prevents early physical therapy practices and restricts postoperative knee rehabilitation and recovery, but it also has negative effects on the respiratory, gastrointestinal, renal, and central nervous systems. Effective management of postoperative acute pain can reduce these complications and the risk of developing chronic pain.
In this study, investigators hypothesized that combined adductor canal and sciatic nerve block, applied with postoperative ultrasound guidance to patients who will undergo TKR surgery under general anesthesia, will provide effective analgesia, less opioid consumption, and faster ambulation time, similar to combined femoral and sciatic nerve block.
Detailed description
As a result of the power analysis investigators conducted for this study, the minimum sample size was calculated as 34 people for each group, 68 people in total, at the 95% confidence interval.
68 patients who meet the inclusion criteria will be included in our study. Patients will be randomized and divided into 2 groups. Accordingly, femoral and sciatic nerve blocks will be applied to 34 patients, and adductor canal and sciatic nerve blocks will be applied to 34 patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group AS | Active comparator | Procedure: Combine Adductor Canal & Sciatic Nerve Block, Drug: Bupivacaine and prilocaine hydrochlorideThe investigators will perform an adductor canal block and sciatic nerve block on that patient group for postoperative analgesia |
| Group FS | Active comparator | Procedure: Combine Femoral & Sciatic Nerve Block, Drug: Bupivacaine and prilocaine hydrochlorideThe investigators will perform femoral and sciatic nerve blocks on that patient group for postoperative analgesia |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages of 40-85
- ASA I-III
- Patients who will undergo total knee replacement surgery under general anesthesia
Key exclusion criteria (5 listed)
- Patients with deformity and pathology in the thigh region
- Clinically known local anesthetic allergy
- Clinically diagnosis of opioid, alcohol and substance dependence
- Patients who cannot perceive and evaluate pain such as psychiatric illness, mental retardation, dementia
- Morbid obesity (body mass index> 40 kg m2)
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 |
|---|---|---|
| Combine Adductor Canal & Sciatic Nerve BlockThe investigators will perform a combined adductor canal \& sciatic nerve block on that patient group for postoperative analgesia | Procedure or surgery | Group AS |
| Combine Femoral & Sciatic Nerve BlockThe investigators will perform a combined femoral \& sciatic nerve block on that patient group for postoperative analgesia | Procedure or surgery | Group FS |
| Bupivacaine and prilocaine hydrochlorideThe investigators will perform a combined adductor canal \& sciatic nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride | Drug | Group AS |
| Bupivacaine and prilocaine hydrochlorideThe investigators will perform a combined femoral \& sciatic nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride | Drug | Group FS |
Primary outcome
The primary outcome measure of the study is the patients' postoperative pain scores (NRS)
Time frame: 72 hours postoperatively
Numerical rating scale (NRS) at 1, 6, 12, 18, 24, 48, 72th hours. NRS assessment score ranges from 0-10. 0 = no pain 10 = worst pain imaginable
1 secondary outcome
The secondary outcome measure will be total opioid consumption in the first 72 hours postoperatively
Time frame: Three days postoperatively
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 8 Jun 2025.
- Background: PubMed 9316950Auroy Y, Narchi P, Messiah A, Litt L, Rouvier B, Samii K. Serious complications related to regional anesthesia: results of a prospective survey in France. Anesthesiology. 1997 Sep;87(3):479-86. doi: 10.1097/00000542-199709000-00005.
- Background: PubMed 18648720Sladjana UZ, Ivan JD, Bratislav SD. Microanatomical structure of the human sciatic nerve. Surg Radiol Anat. 2008 Nov;30(8):619-26. doi: 10.1007/s00276-008-0386-6. Epub 2008 Jul 23.
- Background: PubMed 25131147Currin SS, Mirjalili SA, Meikle G, Stringer MD. Revisiting the surface anatomy of the sciatic nerve in the gluteal region. Clin Anat. 2015 Jan;28(1):144-9. doi: 10.1002/ca.22449. Epub 2014 Aug 8.
- Background: PubMed 19619108Bozkurt M, Yilmazlar A, Bilgen OF. [Comparing the effects of analgesia techniques with controlled intravenous and epidural on postoperative pain and knee rehabilitation after total knee arthroplasty]. Eklem Hastalik Cerrahisi. 2009;20(2):64-70. Turkish.
- Background: PubMed 12677627Gray AT, Collins AB. Ultrasound-guided saphenous nerve block. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):148; author reply 148. doi: 10.1053/rapm.2003.50000. No abstract available.
- Individual participant dataSharing planned: Yes. Data available from the publication date can start. NRS scores and Opioid consumption and side effects will be shared. If requested, data will be shared with anesthesiologists dealing with postoperative analgesia in patients undergoing total knee replacement surgery
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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 Combine Adductor Canal & Sciatic Nerve Block, Combine Femoral & Sciatic Nerve Block and Bupivacaine and prilocaine hydrochloride in people with Orthopedic Disorder and Total Knee Replacement, run by Bakirkoy Dr. Sadi Konuk Research 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 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 8 Jun 2025. 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?
The primary outcome measure of the study is the patients' postoperative pain scores (NRS) (time frame: 72 hours postoperatively). 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 NCT05648708, which also lists 5 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 8 Jun 2025.