Knee DiseaseNCT05289427
Triple Injection Peri-sartorius (TIPS) Block
A study testing ultrasound guided triple injection peri-sartorius block and Femoral Nerve Block in people with Knee Disease and Nerve Pain, run by Alexandria University at 1 site in Egypt.
Trial summary
Comparison between the pain scores after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus femoral nerve block (FNB) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Disease, Nerve Pain
- What is being tested?
- ultrasound guided triple injection peri-sartorius block and Femoral Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 7 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
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: Triple Injection Peri-sartorius (TIPS) Block for Postoperative Analgesia After Total Knee Arthroplasty (TKA): Randomised Controlled Study
Comparison between the pain scores after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus femoral nerve block (FNB)
Read the detailed description
Introduction: Adequate pain control, along with quadriceps muscle preservation, has become a goal among orthopedic departments following TKA(1). The femoral nerve block (FNB) has been for many years the gold standard analgesic therapy for TKA however, it leads to quadriceps weakness(2).
Subsartorial block has been originally prescribed to block sensation in the front and the medial aspect of the knee with little quadriceps weakness (3). Local anaesthetic (LA) injected at the distal third of the adductor canal may enter into the popliteal region along with the femoral vessels to involve the popliteal plexus which supplies the posterior knee joint capsule (4). The anterior femoral cutaneous nerve (AFCN) is the overall term for the intermediate femoral cutaneous nerves (IFCNs) and the medial femoral cutaneous nerve (MFCN). The MFCN innervates the distal medial thigh as well as the anteromedial knee region. It may be anesthetized in the proximal part of the femoral triangle. The IFCN innervates the distal anterior thigh, which includes the proximal part of the surgical incision for TKA. They can be ultrasonographically identified and targeted in the subcutaneous plane on the anterior thigh where they pierce the fascia lata (FL) anterior to the sartorius muscle (SAM) before they ramify in multiple branches(5).
We hypothesize that injection of LA at the femoral triangle level above and below the sartorius muscle and at the distal end of the adductor canal may provide superior analgesia to femoral nerve block alone with little quadriceps weakness in TKA.
Aim of the study: The primary aim of this study is to compare the visual analogue scale scores during the 1st 24 postoperative hours after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus FNB.
The secondary aims of this study are to compare the total postoperative opioid (morphine) consumption, evaluate the effect of the two techniques on the motor power of the operated limb and to detect any complications related to the block or opioids used.
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 80 patients scheduled for unilateral TKA. A total sample size of 80 patients, 40 in each group will be sufficient to provide more than 80 % power at a two sided 0.05 significance level. 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 divided into 2 groups. Group TIPS; patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision. Group FNB; patients will receive femoral nerve block (FNB) before surgical incision.
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. Plan of anaesthesia will be determined by the anesthesiologist in charge. After induction of general anaesthesia or administration of spinal anaesthesia, patients will be randomly divided by a closed envelope method into two groups:
Group TIPS: Patients will receive a combination of supra-sartorius plane block, femoral triangle block and distal ACB. Ten ml of 0.25 % bupivacaine will be injected. Femoral triangle block will be given just (1-2 cm) proximal to the apex of the femoral tringle which is the point at which the medial border of the sartorius muscle (STM) meets the medial border of the adductor longus muscle (ALM). Ten ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected just below the STM. The needle will be withdrawn subcutaneously and another 10 ml of local anesthetic will be injected above the sartorius and below the fascia lata (5). Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal. At this level, femoral vessels dip into the opening of the adductor hiatus to become popliteal vessels. Sonoanatomy of this region shows the adductor magnus muscle (AMM) posteromedially, vastus medialis muscle (VMM) anterolaterally, and the STM medially.(6) Group FNB: Patients will receive single injection of 20 ml 0.25 % bupivacaine mixed with 4 mg dexamethasone about 2 cm below the inguinal ligament. LA mixture will be injected under the fascia iliaca just lateral to the femoral nerve. The femoral artery at this level will appear as a single vessel before bifurcation into profunda femoris and superficial femoral artery.
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 at a dose of 0.05 mg/kg will be given as a rescue analgesic when the VAS ≥4. Resting and dynamic VAS assessment will be carried out every 4 hours during the 24 hour follow up period. Total postoperative morphine requirements will be measured during the postoperative follow up period.
Rehabilitation through physical therapy will be performed by patients during the 24 hour follow up period. Ambulation distances from both morning and evening sessions will be combined into a total ambulatory distance for comparative purposes. Active postoperative knee extension while patients are in seated position will be normalized into degrees of flexion (90°-0°). Physical therapy data will be obtained from physical therapy notes. Postoperative complications related to opioid usage like nausea and vomiting or related to the block like neurological symptoms or falls will be recorded. Postoperative patient satisfaction will be recorded after 24 hours.
- Conditions
- Knee Disease, Nerve Pain
- Being tested
- ultrasound guided triple injection peri-sartorius block, Femoral Nerve Block
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided triple injection peri-sartorius blockProcedure or surgery
Patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision
Femoral Nerve BlockProcedure or surgery
Patients will receive femoral nerve block (FNB) before surgical incision
| Study group | Role | What they receive |
|---|---|---|
| TIPS Block | Experimental | Group TIPS; patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision Receives: Procedure: ultrasound guided triple injection peri-sartorius block |
| FNB | Active comparator | Group FNB; patients will receive femoral nerve block (FNB) before surgical incision Receives: Procedure: Femoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue scale (resting and dynamic, 11 point scale from 0 - 10 where 0 accounts for no pain and 10 accounts for worst pain)
Compare the two groups regarding the visual analogue scale scores
Measured: 24 hours postoperatively
Secondary outcomes (3)
Total postoperative morphine consumption
Compare the total postoperative opioid (morphine) consumption after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus FNB
Measured: 24 hours postoperatively
Operated limb motor power
Compare the two groups regarding the operated limb motor power
Measured: 24 hours postoperatively
Complications
Compare the two groups regarding complications of the two techniques and opioid related side effects
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 posted21 Mar 2022
- Study start1 Apr 2022
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiseaseStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289427
- Sponsor's protocol ID
- 0305449
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the resultsrepoted in this article after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Injection Peri-sartorius (TIPS) Block for Postoperative Analgesia After Total Knee Arthroplasty (TKA): Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05289427
- Acronym / sponsor ID
- 0305449
- Conditions
- Knee Disease, Nerve Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 21 Mar 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.
Comparison between the pain scores after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus femoral nerve block (FNB)
Detailed description
Introduction: Adequate pain control, along with quadriceps muscle preservation, has become a goal among orthopedic departments following TKA(1). The femoral nerve block (FNB) has been for many years the gold standard analgesic therapy for TKA however, it leads to quadriceps weakness(2).
Subsartorial block has been originally prescribed to block sensation in the front and the medial aspect of the knee with little quadriceps weakness (3). Local anaesthetic (LA) injected at the distal third of the adductor canal may enter into the popliteal region along with the femoral vessels to involve the popliteal plexus which supplies the posterior knee joint capsule (4). The anterior femoral cutaneous nerve (AFCN) is the overall term for the intermediate femoral cutaneous nerves (IFCNs) and the medial femoral cutaneous nerve (MFCN). The MFCN innervates the distal medial thigh as well as the anteromedial knee region. It may be anesthetized in the proximal part of the femoral triangle. The IFCN innervates the distal anterior thigh, which includes the proximal part of the surgical incision for TKA. They can be ultrasonographically identified and targeted in the subcutaneous plane on the anterior thigh where they pierce the fascia lata (FL) anterior to the sartorius muscle (SAM) before they ramify in multiple branches(5).
We hypothesize that injection of LA at the femoral triangle level above and below the sartorius muscle and at the distal end of the adductor canal may provide superior analgesia to femoral nerve block alone with little quadriceps weakness in TKA.
Aim of the study: The primary aim of this study is to compare the visual analogue scale scores during the 1st 24 postoperative hours after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus FNB.
The secondary aims of this study are to compare the total postoperative opioid (morphine) consumption, evaluate the effect of the two techniques on the motor power of the operated limb and to detect any complications related to the block or opioids used.
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 80 patients scheduled for unilateral TKA. A total sample size of 80 patients, 40 in each group will be sufficient to provide more than 80 % power at a two sided 0.05 significance level. 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 divided into 2 groups. Group TIPS; patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision. Group FNB; patients will receive femoral nerve block (FNB) before surgical incision.
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. Plan of anaesthesia will be determined by the anesthesiologist in charge. After induction of general anaesthesia or administration of spinal anaesthesia, patients will be randomly divided by a closed envelope method into two groups:
Group TIPS: Patients will receive a combination of supra-sartorius plane block, femoral triangle block and distal ACB. Ten ml of 0.25 % bupivacaine will be injected. Femoral triangle block will be given just (1-2 cm) proximal to the apex of the femoral tringle which is the point at which the medial border of the sartorius muscle (STM) meets the medial border of the adductor longus muscle (ALM). Ten ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected just below the STM. The needle will be withdrawn subcutaneously and another 10 ml of local anesthetic will be injected above the sartorius and below the fascia lata (5). Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal. At this level, femoral vessels dip into the opening of the adductor hiatus to become popliteal vessels. Sonoanatomy of this region shows the adductor magnus muscle (AMM) posteromedially, vastus medialis muscle (VMM) anterolaterally, and the STM medially.(6) Group FNB: Patients will receive single injection of 20 ml 0.25 % bupivacaine mixed with 4 mg dexamethasone about 2 cm below the inguinal ligament. LA mixture will be injected under the fascia iliaca just lateral to the femoral nerve. The femoral artery at this level will appear as a single vessel before bifurcation into profunda femoris and superficial femoral artery.
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 at a dose of 0.05 mg/kg will be given as a rescue analgesic when the VAS ≥4. Resting and dynamic VAS assessment will be carried out every 4 hours during the 24 hour follow up period. Total postoperative morphine requirements will be measured during the postoperative follow up period.
Rehabilitation through physical therapy will be performed by patients during the 24 hour follow up period. Ambulation distances from both morning and evening sessions will be combined into a total ambulatory distance for comparative purposes. Active postoperative knee extension while patients are in seated position will be normalized into degrees of flexion (90°-0°). Physical therapy data will be obtained from physical therapy notes. Postoperative complications related to opioid usage like nausea and vomiting or related to the block like neurological symptoms or falls will be recorded. Postoperative patient satisfaction will be recorded after 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS Block | Experimental | Procedure: ultrasound guided triple injection peri-sartorius blockGroup TIPS; patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision |
| FNB | Active comparator | Procedure: Femoral Nerve BlockGroup FNB; patients will receive femoral nerve block (FNB) before surgical incision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
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 |
|---|---|---|
| ultrasound guided triple injection peri-sartorius blockPatients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision | Procedure or surgery | TIPS Block |
| Femoral Nerve BlockPatients will receive femoral nerve block (FNB) before surgical incision | Procedure or surgery | FNB |
Primary outcome
Visual Analogue scale (resting and dynamic, 11 point scale from 0 - 10 where 0 accounts for no pain and 10 accounts for worst pain)
Time frame: 24 hours postoperatively
Compare the two groups regarding the visual analogue scale scores
3 secondary outcomes
Total postoperative morphine consumption
Time frame: 24 hours postoperatively
Operated limb motor power
Time frame: 24 hours postoperatively
Complications
Time frame: 24 hours
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 10 Mar 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the resultsrepoted in this article after deidentification (text, tables, figures, and appendices)
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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 ultrasound guided triple injection peri-sartorius block and Femoral Nerve Block in people with Knee Disease and Nerve Pain, 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 0 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: finished, as of the sponsor's last update on 10 Mar 2023. 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?
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?
Visual Analogue scale (resting and dynamic, 11 point scale from 0 - 10 where 0 accounts for no pain and 10 accounts for worst pain) (time frame: 24 hours postoperatively). 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 10 Mar 2023; AzTrials last refreshed its copy on 27 Oct 2026.