Total Knee ArthroplastyNCT05447871
Single-injection Modified 4 in 1 Block as Postoperative Analgesia in Total Knee Arthroplasty
A study testing Ultrasound guided single injection modified 4 in 1 block technique, Ultrasound guided adductor canal block technique and Bupivacaine 0.25% in people with Total Knee Arthroplasty, run by Mansoura University at 1 site in Egypt.
Trial summary
Patients suffer from moderate to severe pain after TKA. Patients are asked to begin functional exercise as early as possible after surgery, and that requires adequate control of postoperative pain. Regional anesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Ultrasound guided single injection modified 4 in 1 block technique, Ultrasound guided adductor canal block technique and Bupivacaine 0.25%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2022to Jul 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of 19-30 kg/m2
- American Society of Anesthesiologists (ASA) functional status of I-III
Who cannot join
- Drug hypersensitivity
- coagulopathy
- infection at the site of injection
- Traumatic arthirits
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University
Al Mansurah, DK, 050
Gehan A Trabeeh, MD, 00201061618512, gehan_tarbeeh2011@hotmail.com
Samah A Gouda, MD, 00201002262557, Sk_20022000@yahoo.com
About this study
Official title: Single-injection Modified 4 in 1 Block Versus Adductor Canal Block as Postoperative Analgesia in Total Knee Arthroplasty
Patients suffer from moderate to severe pain after TKA. Patients are asked to begin functional exercise as early as possible after surgery, and that requires adequate control of postoperative pain. Regional anesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. block and motor sparing peripheral nerve block as adductor canal block and IPACK but these blocks have many drawbacks.
So new studies found that a modified 4 in-1 block blocks all these nerves and produces adequate analgesia without sparing areas.
Read the detailed description
Total knee arthroplasty (TKA) is regarded as the most effective method to reduce knee pain and improve knee function in patients with advanced knee osteoarthritis. Postoperative pain is an unpleasant experience for TKA and this pain might greatly influence patients' early rehabilitation.
Almost 60% of patients suffer moderate to severe pain after TKA and 25% of them could even develop related complications, such as longer hospitalization stays, unanticipated hospital admissions, readmissions, etc.
With the development of enhanced recovery after surgery, patients are asked to begin exercise as early as possible after surgery, and that requires adequate control of postoperative pain.
Multimodal systemic analgesia plays an essential role in controlling postoperative pain after TKA by controlling the inflammatory process, dealing with the neuropathic component of pain, and thus reducing the severity of pain.
Multimodal analgesia includes more than one pain-control modality (systemic analgesia and regional anaesthesia). Systemic analgesia includes acetaminophen, nonsteroidal anti-inflammatory drugs, steroids and opioids. Regional anaesthesia includes epidural analgesia, femoral n. block, adductor canal block, sciatic n. block, IPACK, etc. Regional anaesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. block and motor sparing peripheral nerve block as adductor canal block and IPACK.
But these blocks have many drawbacks. Femoral n. block is associated with quadriceps muscle weakness leading to delay in patient's mobility. Sciatic n. block also causes foot drop. The Adductor canal block does not cover the skin on the back of the knee. Surgeons refuse IPACK because of diffusion of local anaesthetics disturbs the anatomy of the surgical field.
The Modified 4 in 1 block technique aims to block four nerves (saphenous nerve, obturator nerve, nerve to vastus medialis and sciatic nerve) through a single injection point by spreading up to the adductor canal in midthigh and below to the popliteal fossa. The investigator will conduct this randomized clinical trial to evaluate the quality of postoperative analgesia produced by a single injection modified 4 in 1 block and midsartorius adductor canal block with regard to total analgesic consumption in the first 24 hours postoperatively
- Conditions
- Total Knee Arthroplasty
- Being tested
- Ultrasound guided single injection modified 4 in 1 block technique, Ultrasound guided adductor canal block technique, Bupivacaine 0.25%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided single injection modified 4 in 1 block techniqueProcedure or surgery
A high-frequency ultrasound probe is placed over the femoral condyle and vastus medialis muscle is identified. The probe is slid proximally till the superficial femoral artery appeared. The probe is slid proximally till the descending genicular artery branching from the superficial femoral artery. The point of interest is 8-10 cm above the femoral condyle. The needle is guided into the Vastus medialis muscle till the nerve to Vastus medialis. At this point, 5-7 mL of the local anaesthetic drug is injected. The needle is guided further in-plane from lateral to medial side to reach the perivascular region and after negative aspiration 25 ml local anaesthetic drug is injected.
Ultrasound guided adductor canal block techniqueProcedure or surgery
The Adductor canal is identified in the middle of the thigh beneath the sartorius muscle using a high-frequency ultrasonic transducer. the probe is slid till the superficial femoral artery appeared in the adductor canal between vastus medialis and adductor longus muscle. A 22-gauge spinal needle is inserted in a lateral to medial plane to reach the perivascular region and after negative aspiration 20 ml local anaesthetic drug is injected, visualised to push the femoral artery.
Bupivacaine 0.25%Drug
bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided single injection modified 4 in 1 block technique | Experimental | Patients in this group will receive ultrasound guided single injection modified 4 in 1 block with 25 ml bupivacaine 0.25% Receives: Procedure: Ultrasound guided single injection modified 4 in 1 block technique; Drug: Bupivacaine 0.25% |
| Ultrasound guided adductor canal block technique | Active comparator | Patients in this group will receive ultrasound guided aduuctor canal block with 20 ml bupivacaine 0.25% Receives: Procedure: Ultrasound guided adductor canal block technique; Drug: Bupivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of postoperative analgesia in first 24 hours
calculate total amount of morphine hydrochloride which patient will need in first 24 hours postoperative.
Measured: in first 24 hours
Secondary outcomes (6)
Duration of sensory block.
return of pinbrick sensation on the lateral aspect of the foot (S1)
Measured: 3, 6, 12, 24 hours postoperative
Duration of motor block.
motor block is tested and recoded every 30 min till Bromage score is zero
Measured: 3, 6, 12, 24 hours postoperative
Total distance patient will be able to ambulate on first postoperative day
the distance that patient will be able to walk on the first postoperative day (meters)
Measured: on first postoperative day
intraoperative non invasive blood pressure(NIBP) mmHg
NIBP will be measured and recorded.
Measured: every 10 minutes after spinal anesthesia till the end of the surgery
intraoperative heart rate beat per minute
heart rate will be monitored and recorded.
Measured: every 10 minutes after spinal anesthesia till the end of the surgery.
postoperative hypotension mmHg
blood pressure will be measured and recorded
Measured: at 1, 3, 6, 12 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gehan A Trabeeh, MD, Study chair, Professor of Anesthesia and Surgical Intensive CareSamah A Gouda, MD, Study director, Assistant Professor of Anesthesia and Surgical Intensive CareSamar A Alattar, M.Sec, Principal investigator, Assistant lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447871
- Sponsor's protocol ID
- MFM-IRB: MD. 22.03.629
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Supporting Information:
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-injection Modified 4 in 1 Block Versus Adductor Canal Block as Postoperative Analgesia in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05447871
- Acronym / sponsor ID
- MFM-IRB: MD. 22.03.629
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 7 Jul 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.
Patients suffer from moderate to severe pain after TKA. Patients are asked to begin functional exercise as early as possible after surgery, and that requires adequate control of postoperative pain. Regional anesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. block and motor sparing peripheral nerve block as adductor canal block and IPACK but these blocks have many drawbacks.
So new studies found that a modified 4 in-1 block blocks all these nerves and produces adequate analgesia without sparing areas.
Detailed description
Total knee arthroplasty (TKA) is regarded as the most effective method to reduce knee pain and improve knee function in patients with advanced knee osteoarthritis. Postoperative pain is an unpleasant experience for TKA and this pain might greatly influence patients' early rehabilitation.
Almost 60% of patients suffer moderate to severe pain after TKA and 25% of them could even develop related complications, such as longer hospitalization stays, unanticipated hospital admissions, readmissions, etc.
With the development of enhanced recovery after surgery, patients are asked to begin exercise as early as possible after surgery, and that requires adequate control of postoperative pain.
Multimodal systemic analgesia plays an essential role in controlling postoperative pain after TKA by controlling the inflammatory process, dealing with the neuropathic component of pain, and thus reducing the severity of pain.
Multimodal analgesia includes more than one pain-control modality (systemic analgesia and regional anaesthesia). Systemic analgesia includes acetaminophen, nonsteroidal anti-inflammatory drugs, steroids and opioids. Regional anaesthesia includes epidural analgesia, femoral n. block, adductor canal block, sciatic n. block, IPACK, etc. Regional anaesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. block and motor sparing peripheral nerve block as adductor canal block and IPACK.
But these blocks have many drawbacks. Femoral n. block is associated with quadriceps muscle weakness leading to delay in patient's mobility. Sciatic n. block also causes foot drop. The Adductor canal block does not cover the skin on the back of the knee. Surgeons refuse IPACK because of diffusion of local anaesthetics disturbs the anatomy of the surgical field.
The Modified 4 in 1 block technique aims to block four nerves (saphenous nerve, obturator nerve, nerve to vastus medialis and sciatic nerve) through a single injection point by spreading up to the adductor canal in midthigh and below to the popliteal fossa. The investigator will conduct this randomized clinical trial to evaluate the quality of postoperative analgesia produced by a single injection modified 4 in 1 block and midsartorius adductor canal block with regard to total analgesic consumption in the first 24 hours postoperatively
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided single injection modified 4 in 1 block technique | Experimental | Procedure: Ultrasound guided single injection modified 4 in 1 block technique, Drug: Bupivacaine 0.25%Patients in this group will receive ultrasound guided single injection modified 4 in 1 block with 25 ml bupivacaine 0.25% |
| Ultrasound guided adductor canal block technique | Active comparator | Procedure: Ultrasound guided adductor canal block technique, Drug: Bupivacaine 0.25%Patients in this group will receive ultrasound guided aduuctor canal block with 20 ml bupivacaine 0.25% |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) of 19-30 kg/m2
- American Society of Anesthesiologists (ASA) functional status of I-III
Key exclusion criteria (4 listed)
- Drug hypersensitivity
- coagulopathy
- infection at the site of injection
- Traumatic arthirits
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 |
|---|---|---|
| Ultrasound guided single injection modified 4 in 1 block techniqueA high-frequency ultrasound probe is placed over the femoral condyle and vastus medialis muscle is identified. The probe is slid proximally till the superficial femoral artery appeared. The probe is slid proximally till the descending genicular artery branching from the superficial femoral artery. The point of interest is 8-10 cm above the femoral condyle. The needle is guided into the Vastus medialis muscle till the nerve to Vastus medialis. At this point, 5-7 mL of the local anaesthetic drug is injected. The needle is guided further in-plane from lateral to medial side to reach the perivascular region and after negative aspiration 25 ml local anaesthetic drug is injected. | Procedure or surgery | Ultrasound guided single injection modified 4 in 1 block technique |
| Ultrasound guided adductor canal block techniqueThe Adductor canal is identified in the middle of the thigh beneath the sartorius muscle using a high-frequency ultrasonic transducer. the probe is slid till the superficial femoral artery appeared in the adductor canal between vastus medialis and adductor longus muscle. A 22-gauge spinal needle is inserted in a lateral to medial plane to reach the perivascular region and after negative aspiration 20 ml local anaesthetic drug is injected, visualised to push the femoral artery. | Procedure or surgery | Ultrasound guided adductor canal block technique |
| Bupivacaine 0.25%bupivacaine 0.25% | Drug | Ultrasound guided adductor canal block technique, Ultrasound guided single injection modified 4 in 1 block technique |
Primary outcome
Total amount of postoperative analgesia in first 24 hours
Time frame: in first 24 hours
calculate total amount of morphine hydrochloride which patient will need in first 24 hours postoperative.
6 secondary outcomes
Duration of sensory block.
Time frame: 3, 6, 12, 24 hours postoperative
Duration of motor block.
Time frame: 3, 6, 12, 24 hours postoperative
Total distance patient will be able to ambulate on first postoperative day
Time frame: on first postoperative day
intraoperative non invasive blood pressure(NIBP) mmHg
Time frame: every 10 minutes after spinal anesthesia till the end of the surgery
intraoperative heart rate beat per minute
Time frame: every 10 minutes after spinal anesthesia till the end of the surgery.
postoperative hypotension mmHg
Time frame: at 1, 3, 6, 12 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: Yes. Yes, Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Supporting Information:
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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.
Gehan A Trabeeh, MD study chair
Professor of Anesthesia and Surgical Intensive Care
Samah A Gouda, MD study director
Assistant Professor of Anesthesia and Surgical Intensive Care
Samar A Alattar, M.Sec principal investigator
Assistant lecturer of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided single injection modified 4 in 1 block technique, Ultrasound guided adductor canal block technique and Bupivacaine 0.25% in people with Total Knee Arthroplasty, run by Mansoura 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: status not confirmed, as of the sponsor's last update on 7 Jul 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 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gehan A Trabeeh, MD (00201061618512, gehan_tarbeeh2011@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of postoperative analgesia in first 24 hours (time frame: in first 24 hours). 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 7 Jul 2022.