Knee ArthropathyPhase 4NCT06539910
Modified TIPS Block for Total Knee Arthroplasty
A Phase 4 study testing General Anesthesia, TIPS block and Modified TIPS block in people with Knee Arthropathy and Anesthesia, Local, run by Alexandria University at 1 site in Egypt.
Trial summary
The is carried out to compare triple injection peri-sartorial block to a modified block including an extra local anesthetic injection deep to the adductor longs muscle via a medial to lateral approach regarding the peri-operative analgesia following total knee arthroplasty (TKA) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthropathy, Anesthesia, Local
- What is being tested?
- General Anesthesia, TIPS block and Modified TIPS block
- 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
- Aug 2024to Mar 2025
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III
Who cannot join
- BMI > 35 kg/m2 Pre-existing neurological deficit Any disability of the non-operated limb preventing fair mobilization Known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection) Chronic opioid users/abusers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Triple Injection Peri-Sartorius (TIPS) Block for Postoperative Analgesia After Total Knee Arthroplasty (TKA)
The is carried out to compare triple injection peri-sartorial block to a modified block including an extra local anesthetic injection deep to the adductor longs muscle via a medial to lateral approach regarding the peri-operative analgesia following total knee arthroplasty (TKA)
Read the detailed description
We hypothesise that LA injection at a plane deep to adductor longus muscle at the level of femoral triangle may block the 2 divisions of the ON and improve analgesia following TKA. Moreover, the medial to lateral needle trajectory may avoid NVM injury.
Aim of the work: The primary aim of this study is to determine if addition of LA injection underneath the ALM targeting ON divisions to tri-injection perisartorius (TIPS) block, may decrease the postoperative opioid rescue analgesic requirements after TKA.
The secondary aim of this study is to investigate the effect of addition of LA injection under the ALM to TIPS block on the resting and dynamic VAS scores during the 1st 24 h postoperative period. The secondary aims include the time to the 1st request of rescue analgesia, the motor power of the operated limb as well as any complication related to the block technique.
Methods: After obtaining approval from Alexandria university ethics committee, this study will be carried out in El-Hadara university hospital on American Society of Anesthesiologists (ASA) physical status I-III 90 patients scheduled for unilateral TKA. Based on a pilot study, a total sample size of 90 participants - 45 patients in TIPS group and 45 patients in mTIPS group - is needed to achieve 80% power and to detect difference of 0.6 mg in the mean of morphine consumption between the two groups with group standard deviations of 1 Using t test (a two-sided two-sample t-test) at a significance level of 05. Sample size was calculated using NCSS 2004 and PASS 2000 program. Informed written consent will be signed by all patients. The visual analogue scale (VAS) score interpretation and the use of patient controlled analgesia (PCA) device will be explained to all participants. The exclusion criteria will include; BMI > 35 kg/m2, pre-existing neurological deficit, any disability of the non-operated limb preventing fair mobilization, known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection), or chronic opioid users/abusers. Patients will be randomised into 2 groups using a closed envelope technique:
Group TIPS: patients will receive distal FTB through conventional lateral to medial approach, in addition to a supra-sartorial plane injection.
Group MTIPS: patients will receive ultrasound guided single puncture triple injections through medial to lateral approach. LA will be injected at the distal FT lateral to the superficial femoral artery (FA), deep to adductor longus muscle (ALM), and at the supra-sartorial plane.
Both groups will receive distal adductor canal block via another needle puncture.
All blocks will be performed after induction of general anaesthesia (GA). Upon arrival to the operating room (OR), a multichannel monitor will be attached to patients, followed by the administration of 2 mg midazolam IV after securing an IV cannula. Controlled GA via a laryngeal mask airway (LMA) will be done to all patients
Both groups will receive a mixture of 0.25 % bupivacaine and 8 mg dexamethasone. Ten mL will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal. The total volume of LA will be determined according to group selection:
Group TIPS: Ten mL of the LA mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane lateral to medial approach just lateral to the superficial femoral artery. Then, the needle will be redirected to perform the suprasartorial plane injection. Total volume of LA will be 40 mL.
Group MTIPS: Ten mL of the LA anaesthetic mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane medial to lateral approach just lateral to the superficial femoral artery. Then, the needle will be redirected just underneath the ALM and 10 mL of the LA mixture will be injected in the plane between the ALM and the adductor magnus muscle (AMM). Again, the needle will be redirected to perform the suprasartorial plane injection. Total volume of LA will be 50 mL.
Postoperatively, multimodal analgesia regimen will be continued in the form of paracetamol 1 g /8 hours and ketorolac 30 mg /8 hours intravenously for 24 hours. Intravenous morphine patient controlled analgesia will be started at the end of surgery at a concentration of 0.5 mg/ml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes. The time to the 1st demand dose of rescue analgesia will be recorded. Resting and dynamic VAS assessment will be carried out every 4 hours during the 24 h follow up period. Total postoperative morphine requirements will be measured during the 24 h postoperative follow up period. Postoperative functional outcome will be assessed using the Timed Up and Go (TUG) test and the 30-second Chair Stand Test (30s-CST) in the evening of the day of surgery.
- Conditions
- Knee Arthropathy, Anesthesia, Local
- Being tested
- General Anesthesia, TIPS block, Modified TIPS block, Mutimodal analgesia
- Keywords
- Analgesia, arthroplasty, knee replacement, nerve block, peri-sartorial block, triple injection, visual analogue scale
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaProcedure or surgery
All blocks will be performed after induction of general anaesthesia (GA). Upon arrival to the operating room (OR), a multichannel monitor will be attached to patients, followed by the administration of 2 mg midazolam IV after securing an IV cannula. Controlled GA via a laryngeal mask airway (LMA) will be done to all patients
TIPS blockProcedure or surgery
Patients will receive distal FTB through conventional lateral to medial approach, in addition to a supra-sartorial plane injection. Distal adductor canal block via another needle puncture.Ten mL of a mixture of 0.25 % bupivacaine and 8 mg dexamethasone will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal.Ten mL of the LA mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane lateral to medial approach just lateral to the superficial femoral artery
Modified TIPS blockProcedure or surgery
Patients will receive ultrasound guided single puncture triple injections through medial to lateral approach. LA will be injected at the distal FT lateral to the superficial femoral artery (FA), deep to adductor longus muscle (ALM), and at the supra-sartorial plane.Both groups will receive a mixture of 0.25 % bupivacaine and 8 mg dexamethasone. Ten mL will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal.Ten mL of the LA anaesthetic mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane medial to lateral approach just lateral to the superficial femoral artery. Then, the needle will be redirected just underneath the ALM and 10 mL of the LA mixture will be injected in the plane between the ALM and the adductor magnus muscle (AMM).Total volume of LA will be 50 mL.
Mutimodal analgesiaProcedure or surgery
Postoperatively, multimodal analgesia regimen will be continued in the form of paracetamol 1 g /8 hours and ketorolac 30 mg /8 hours intravenously for 24 hours. Intravenous morphine patient controlled analgesia will be started at the end of surgery at a concentration of 0.5 mg/ml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Modified TIPS Block | Experimental | Modified Triple Injection Peri-sartorial Block Patients will receive ultrasound guided single puncture triple injections through medial to lateral approach. LA will be injected at the distal FT lateral to the superficial femoral artery (FA), deep to adductor longus muscle (ALM), and at the supra-sartorial plane Receives: Procedure: General Anesthesia; Procedure: TIPS block; Procedure: Mutimodal analgesia |
| TIPS Block | Active comparator | Triple Injection Peri-sartorial Block Patients will receive distal FTB through conventional lateral to medial approach, in addition to a supra-sartorial plane injection Receives: Procedure: General Anesthesia; Procedure: Modified TIPS block; Procedure: Mutimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid rescue analgesic requirements
Intravenous morphine patient controlled analgesia will be started at the end of surgery at a concentration of 0.5 mg/ml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes. Total postoperative morphine consumption will be measured
Measured: 24 hours
Secondary outcomes (4)
The time to the 1st demand dose of rescue analgesia
The time to the 1st demand dose of rescue analgesia will be recorded
Measured: 24 hours
Resting and dynamic VAS assessment
Resting and dynamic VAS assessment will be carried out every 4 hours
Measured: 24 hours
Timed Up and Go (TUG) test
Timed Up and Go (TUG) test
Measured: 24 hours
30-second Chair Stand Test (30s-CST)
30-second Chair Stand Test (30s-CST)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, moustafa abdelaziz, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539910
- Sponsor's protocol ID
- 0306646
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon request via mail to the principal investigator
Publications
Woodworth GE, Arner A, Nelsen S, Nada E, Elkassabany NM. Pro and Con: How Important Is the Exact Location of Adductor Canal and Femoral Triangle Blocks? Anesth Analg. 2023 Mar 1;136(3):458-469. doi: 10.1213/ANE.0000000000006234. Epub 2023 Feb 17.
PubMed 36806233
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Triple Injection Peri-Sartorius (TIPS) Block for Postoperative Analgesia After Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT06539910
- Acronym / sponsor ID
- 0306646
- Conditions
- Knee Arthropathy, Anesthesia, Local
- Keywords
- Analgesia, arthroplasty, knee replacement, nerve block, peri-sartorial block, triple injection, visual analogue scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 Aug 2024 (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.
The is carried out to compare triple injection peri-sartorial block to a modified block including an extra local anesthetic injection deep to the adductor longs muscle via a medial to lateral approach regarding the peri-operative analgesia following total knee arthroplasty (TKA)
Detailed description
We hypothesise that LA injection at a plane deep to adductor longus muscle at the level of femoral triangle may block the 2 divisions of the ON and improve analgesia following TKA. Moreover, the medial to lateral needle trajectory may avoid NVM injury.
Aim of the work: The primary aim of this study is to determine if addition of LA injection underneath the ALM targeting ON divisions to tri-injection perisartorius (TIPS) block, may decrease the postoperative opioid rescue analgesic requirements after TKA.
The secondary aim of this study is to investigate the effect of addition of LA injection under the ALM to TIPS block on the resting and dynamic VAS scores during the 1st 24 h postoperative period. The secondary aims include the time to the 1st request of rescue analgesia, the motor power of the operated limb as well as any complication related to the block technique.
Methods: After obtaining approval from Alexandria university ethics committee, this study will be carried out in El-Hadara university hospital on American Society of Anesthesiologists (ASA) physical status I-III 90 patients scheduled for unilateral TKA. Based on a pilot study, a total sample size of 90 participants - 45 patients in TIPS group and 45 patients in mTIPS group - is needed to achieve 80% power and to detect difference of 0.6 mg in the mean of morphine consumption between the two groups with group standard deviations of 1 Using t test (a two-sided two-sample t-test) at a significance level of 05. Sample size was calculated using NCSS 2004 and PASS 2000 program. Informed written consent will be signed by all patients. The visual analogue scale (VAS) score interpretation and the use of patient controlled analgesia (PCA) device will be explained to all participants. The exclusion criteria will include; BMI > 35 kg/m2, pre-existing neurological deficit, any disability of the non-operated limb preventing fair mobilization, known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection), or chronic opioid users/abusers. Patients will be randomised into 2 groups using a closed envelope technique:
Group TIPS: patients will receive distal FTB through conventional lateral to medial approach, in addition to a supra-sartorial plane injection.
Group MTIPS: patients will receive ultrasound guided single puncture triple injections through medial to lateral approach. LA will be injected at the distal FT lateral to the superficial femoral artery (FA), deep to adductor longus muscle (ALM), and at the supra-sartorial plane.
Both groups will receive distal adductor canal block via another needle puncture.
All blocks will be performed after induction of general anaesthesia (GA). Upon arrival to the operating room (OR), a multichannel monitor will be attached to patients, followed by the administration of 2 mg midazolam IV after securing an IV cannula. Controlled GA via a laryngeal mask airway (LMA) will be done to all patients
Both groups will receive a mixture of 0.25 % bupivacaine and 8 mg dexamethasone. Ten mL will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal. The total volume of LA will be determined according to group selection:
Group TIPS: Ten mL of the LA mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane lateral to medial approach just lateral to the superficial femoral artery. Then, the needle will be redirected to perform the suprasartorial plane injection. Total volume of LA will be 40 mL.
Group MTIPS: Ten mL of the LA anaesthetic mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane medial to lateral approach just lateral to the superficial femoral artery. Then, the needle will be redirected just underneath the ALM and 10 mL of the LA mixture will be injected in the plane between the ALM and the adductor magnus muscle (AMM). Again, the needle will be redirected to perform the suprasartorial plane injection. Total volume of LA will be 50 mL.
Postoperatively, multimodal analgesia regimen will be continued in the form of paracetamol 1 g /8 hours and ketorolac 30 mg /8 hours intravenously for 24 hours. Intravenous morphine patient controlled analgesia will be started at the end of surgery at a concentration of 0.5 mg/ml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes. The time to the 1st demand dose of rescue analgesia will be recorded. Resting and dynamic VAS assessment will be carried out every 4 hours during the 24 h follow up period. Total postoperative morphine requirements will be measured during the 24 h postoperative follow up period. Postoperative functional outcome will be assessed using the Timed Up and Go (TUG) test and the 30-second Chair Stand Test (30s-CST) in the evening of the day of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Modified TIPS Block | Experimental | Procedure: General Anesthesia, Procedure: TIPS block, Procedure: Mutimodal analgesiaModified Triple Injection Peri-sartorial Block Patients will receive ultrasound guided single puncture triple injections through medial to lateral approach. LA will be injected at the distal FT lateral to the superficial femoral artery (FA), deep to adductor longus muscle (ALM), and at the supra-sartorial plane |
| TIPS Block | Active comparator | Procedure: General Anesthesia, Procedure: Modified TIPS block, Procedure: Mutimodal analgesiaTriple Injection Peri-sartorial Block Patients will receive distal FTB through conventional lateral to medial approach, in addition to a supra-sartorial plane injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I-III
Key exclusion criteria (1 listed)
- BMI > 35 kg/m2 Pre-existing neurological deficit Any disability of the non-operated limb preventing fair mobilization Known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection) Chronic opioid users/abusers
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 |
|---|---|---|
| General AnesthesiaAll blocks will be performed after induction of general anaesthesia (GA). Upon arrival to the operating room (OR), a multichannel monitor will be attached to patients, followed by the administration of 2 mg midazolam IV after securing an IV cannula. Controlled GA via a laryngeal mask airway (LMA) will be done to all patients | Procedure or surgery | Modified TIPS Block, TIPS Block |
| TIPS blockPatients will receive distal FTB through conventional lateral to medial approach, in addition to a supra-sartorial plane injection. Distal adductor canal block via another needle puncture.Ten mL of a mixture of 0.25 % bupivacaine and 8 mg dexamethasone will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal.Ten mL of the LA mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane lateral to medial approach just lateral to the superficial femoral artery | Procedure or surgery | Modified TIPS Block |
| Modified TIPS blockPatients will receive ultrasound guided single puncture triple injections through medial to lateral approach. LA will be injected at the distal FT lateral to the superficial femoral artery (FA), deep to adductor longus muscle (ALM), and at the supra-sartorial plane.Both groups will receive a mixture of 0.25 % bupivacaine and 8 mg dexamethasone. Ten mL will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal.Ten mL of the LA anaesthetic mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane medial to lateral approach just lateral to the superficial femoral artery. Then, the needle will be redirected just underneath the ALM and 10 mL of the LA mixture will be injected in the plane between the ALM and the adductor magnus muscle (AMM).Total volume of LA will be 50 mL. | Procedure or surgery | TIPS Block |
| Mutimodal analgesiaPostoperatively, multimodal analgesia regimen will be continued in the form of paracetamol 1 g /8 hours and ketorolac 30 mg /8 hours intravenously for 24 hours. Intravenous morphine patient controlled analgesia will be started at the end of surgery at a concentration of 0.5 mg/ml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes | Procedure or surgery | Modified TIPS Block, TIPS Block |
Primary outcome
Postoperative opioid rescue analgesic requirements
Time frame: 24 hours
Intravenous morphine patient controlled analgesia will be started at the end of surgery at a concentration of 0.5 mg/ml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes. Total postoperative morphine consumption will be measured
4 secondary outcomes
The time to the 1st demand dose of rescue analgesia
Time frame: 24 hours
Resting and dynamic VAS assessment
Time frame: 24 hours
Timed Up and Go (TUG) test
Time frame: 24 hours
30-second Chair Stand Test (30s-CST)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Results publication: PubMed 36806233Woodworth GE, Arner A, Nelsen S, Nada E, Elkassabany NM. Pro and Con: How Important Is the Exact Location of Adductor Canal and Femoral Triangle Blocks? Anesth Analg. 2023 Mar 1;136(3):458-469. doi: 10.1213/ANE.0000000000006234. Epub 2023 Feb 17.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon request via mail to the principal investigator
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing General Anesthesia, TIPS block and Modified TIPS block in people with Knee Arthropathy and Anesthesia, Local, run by Alexandria 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 1 inclusion and 1 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 6 Aug 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 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 moustafa Abdelaziz, MD (1222373407 ext. +20, m.3abdelaziz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid rescue analgesic requirements (time frame: 24 hours). 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 NCT06539910, which also lists 1 linked publication.
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 6 Aug 2024.