Femoral Triangle BlockNCT06402110
Femoral Triangle Block Versus Adductor Canal Block in Arthroscopic Anterior Cruciate Ligament Reconstruction
A study testing Femoral Triangle Block and Adductor Canal Block in people with Femoral Triangle Block and Adductor Canal Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the postoperative analgesic effect of femoral triangle block (FTB) and adductor canal block (ACB)after arthroscopic anterior cruciate ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Femoral Triangle Block, Adductor Canal Block, Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Femoral Triangle Block and Adductor Canal Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 7 May 2024to 27 Apr 2025
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I and II.
- Undergoing elective arthroscopic Anterior Cruciate Ligament (ACL) reconstruction.
Who cannot join
- Revisional surgery.
- Body mass index (BMI) >35kg/m2.
- Coagulopathy.
- Infection at site of intervention.
- Hypersensitive to the study drugs.
- Chronic analgesic use.
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- Neuromuscular disease.
- Drug abuse.
- Cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Femoral Triangle Block Versus Adductor Canal Block for Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Trial
The aim of this study is to compare the postoperative analgesic effect of femoral triangle block (FTB) and adductor canal block (ACB)after arthroscopic anterior cruciate ligament (ACL) reconstruction.
Read the detailed description
The number of patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction has risen over the past decade. ACL reconstruction is associated with moderate to severe postoperative pain leading to hypertension, tachycardia, increased O2 demand, and myocardial stress.
- Being tested
- Femoral Triangle Block, Adductor Canal Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Triangle BlockOther
Patients will receive femoral triangle block (FTB) at the end of surgery. The probe will be positioned at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle, a block needle advanced in an in-plane technique into femoral triangle. After negative aspiration, 2ml of saline will be injected to confirm the needle tip position close to the femoral artery then injection of 15ml of bupivacaine 0.25% will be performed.
Adductor Canal BlockOther
Patients will receive adductor canal block (ACB) at the end of surgery. The probe will be positioned at the point midway between the anterior superior iliac spine and the upper pole of the patella. The adductor canal will be located as a hyperechoic structure beneath the Sartorius muscle and a block needle advanced in an in-plane technique toward the target nerve after negative aspiration, 2ml of saline will be injected into adductor canal to confirm the block needle tip within it, the block needle will be advanced with the guidance of ultrasound in an in-plane technique and 15ml bupivacaine 0.25% will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Femoral Triangle Block (FTB) Group | Experimental | Patients will receive femoral triangle block (FTB) at the end of surgery. Receives: Other: Femoral Triangle Block |
| Adductor Canal Block (ACB) Group | Experimental | Patients will receive adductor canal block (ACB) at the end of surgery. Receives: Other: Adductor Canal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia of 3 mg morphine IV will be given if the Numeric Rating Scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4. NRS will be assessed at 2, 4, 6, 12, and 24h postoperatively
Measured: 24 hours postoperatively
Secondary outcomes (4)
Time of 1st rescue analgesia
Postoperatively, all patients will receive paracetamol 1gm/6h and diclofenac sodium 75mg I.M/12h as regular analgesia. Rescue analgesia of 3 mg morphine IV will be given if the Numeric Rating Scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4. NRS will be assessed at 2, 4, 6, 12, and 24h postoperatively.
Measured: 24 hours postoperatively
Pain score using Numeric Rating Scale (NRS)
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) (0 represents "no pain" while 10 represents "the worst pain imaginable"). It will be assessed at 2, 4, 6, 12, and 24h postoperatively.
Measured: 24 hours postoperatively
Quadriceps strength
Quadriceps strength will be assessed at 2, 4, 6, 12, and 24h postoperatively. The criteria for evaluation of quadriceps strength are as follow: I (no contraction), II (have contraction, but cannot move joint), III (can move joint, but cannot resist gravity), IV (can resist gravity, but cannot bear substantial resistance), V (can bear a certain intensity of resistance), and VI (can bear full resistance).
Measured: 24 hours postoperatively
Patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start7 May 2024
- Primary completion27 Apr 2025
- Study completion27 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Triangle BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402110
- Sponsor's protocol ID
- 36264MS559/4/24
- Status last verified
- Jul 2025
- First submitted
- 2 May 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Triangle Block Versus Adductor Canal Block for Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06402110
- Acronym / sponsor ID
- 36264MS559/4/24
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 27 Apr 2025 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 7 May 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 aim of this study is to compare the postoperative analgesic effect of femoral triangle block (FTB) and adductor canal block (ACB)after arthroscopic anterior cruciate ligament (ACL) reconstruction.
Detailed description
The number of patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction has risen over the past decade. ACL reconstruction is associated with moderate to severe postoperative pain leading to hypertension, tachycardia, increased O2 demand, and myocardial stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Triangle Block (FTB) Group | Experimental | Other: Femoral Triangle BlockPatients will receive femoral triangle block (FTB) at the end of surgery. |
| Adductor Canal Block (ACB) Group | Experimental | Other: Adductor Canal BlockPatients will receive adductor canal block (ACB) at the end of surgery. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I and II.
- Undergoing elective arthroscopic Anterior Cruciate Ligament (ACL) reconstruction.
Key exclusion criteria (9 listed)
- Revisional surgery.
- Body mass index (BMI) >35kg/m2.
- Coagulopathy.
- Infection at site of intervention.
- Hypersensitive to the study drugs.
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 |
|---|---|---|
| Femoral Triangle BlockPatients will receive femoral triangle block (FTB) at the end of surgery. The probe will be positioned at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle, a block needle advanced in an in-plane technique into femoral triangle. After negative aspiration, 2ml of saline will be injected to confirm the needle tip position close to the femoral artery then injection of 15ml of bupivacaine 0.25% will be performed. | Other | Femoral Triangle Block (FTB) Group |
| Adductor Canal BlockPatients will receive adductor canal block (ACB) at the end of surgery. The probe will be positioned at the point midway between the anterior superior iliac spine and the upper pole of the patella. The adductor canal will be located as a hyperechoic structure beneath the Sartorius muscle and a block needle advanced in an in-plane technique toward the target nerve after negative aspiration, 2ml of saline will be injected into adductor canal to confirm the block needle tip within it, the block needle will be advanced with the guidance of ultrasound in an in-plane technique and 15ml bupivacaine 0.25% will be injected. | Other | Adductor Canal Block (ACB) Group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Rescue analgesia of 3 mg morphine IV will be given if the Numeric Rating Scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4. NRS will be assessed at 2, 4, 6, 12, and 24h postoperatively
4 secondary outcomes
Time of 1st rescue analgesia
Time frame: 24 hours postoperatively
Pain score using Numeric Rating Scale (NRS)
Time frame: 24 hours postoperatively
Quadriceps strength
Time frame: 24 hours postoperatively
Patient satisfaction
Time frame: 24 hours 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 31 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Femoral Triangle Block and Adductor Canal Block in people with Femoral Triangle Block and Adductor Canal Block, run by Tanta 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 4 inclusion and 9 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 31 Jul 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 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?
Total morphine consumption (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 31 Jul 2025.