- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06402110
Femoral Triangle Block Versus Adductor Canal Block in Arthroscopic Anterior Cruciate Ligament Reconstruction
July 30, 2025 updated by: Mohammed Said ElSharkawy, Tanta University
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Revisional surgery.
- Body mass index (BMI) >35kg/m2.
- Coagulopathy.
- Infection at site of intervention.
- Hypersensitive to the study drugs.
- Chronic analgesic use.
- Neuromuscular disease.
- Drug abuse.
- Cognitive impairment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Femoral Triangle Block (FTB) Group
Patients will receive femoral triangle block (FTB) at the end of surgery.
|
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.
|
|
Experimental: Adductor Canal Block (ACB) Group
Patients will receive adductor canal block (ACB) at the end of surgery.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of 1st rescue analgesia
Time Frame: 24 hours postoperatively
|
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.
|
24 hours postoperatively
|
|
Pain score using Numeric Rating Scale (NRS)
Time Frame: 24 hours postoperatively
|
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.
|
24 hours postoperatively
|
|
Quadriceps strength
Time Frame: 24 hours postoperatively
|
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).
|
24 hours postoperatively
|
|
Patient satisfaction
Time Frame: 24 hours postoperatively
|
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)
|
24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2024
Primary Completion (Actual)
April 27, 2025
Study Completion (Actual)
April 27, 2025
Study Registration Dates
First Submitted
May 2, 2024
First Submitted That Met QC Criteria
May 2, 2024
First Posted (Actual)
May 7, 2024
Study Record Updates
Last Update Posted (Actual)
July 31, 2025
Last Update Submitted That Met QC Criteria
July 30, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 36264MS559/4/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
After the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anterior Cruciate Ligament Reconstruction
-
Federal University of Health Science of Porto AlegreRecruitingAnterior Cruciate Ligament Reconstruction | Anterior Cruciate Ligament Reconstruction RehabilitationBrazil
-
Federal University of Health Science of Porto AlegreRecruitingAnterior Cruciate Ligament Reconstruction | Anterior Cruciate Ligament Reconstruction RehabilitationBrazil
-
Egas Moniz - Cooperativa de Ensino Superior, CRLRecruitingAnterior Cruciate Ligament Reconstruction | Athlete | Anterior Cruciate Ligament Reconstruction RehabilitationPortugal
-
Hacettepe UniversityRecruitingAnterior Cruciate Ligament Reconstruction Rehabilitation | Strength Outcomes | Anterior Cruciate Ligament (ACL) Reconstruction SurgeryTurkey (Türkiye)
-
University of Sao Paulo General HospitalUnknownAnterior Cruciate Ligament Reconstruction | Rehabilitation | Anterolateral Ligament ReconstructionBrazil
-
Hospital for Special Surgery, New YorkRecruitingAnterior Cruciate Ligament Reconstruction | Medial Patellofemoral Ligament ReconstructionUnited States
-
Universiti Sains MalaysiaNot yet recruitingAnterior Cruciate Ligament ReconstructionChina
-
Marquette UniversityRecruitingAnterior Cruciate Ligament ReconstructionUnited States
-
Assaf-Harofeh Medical CenterRecruitingAnterior Cruciate Ligament ReconstructionIsrael
-
Linnaeus UniversityNot yet recruitingAnterior Cruciate Ligament ReconstructionSweden
Clinical Trials on Femoral Triangle Block
-
Karaman Training and Research HospitalRecruitingOsteo Arthritis of the KneeTurkey (Türkiye)
-
Clinique Medipole GaronneCompletedPrimary Total Knee ArthroplastyFrance
-
Social Medical Corporation DaiyukaiRecruitingTotal Knee Arthroplasty | Total Knee Arthroplasty Recovery | Total Knee Arthroplasty Postoperative PainJapan
-
Lithuanian University of Health SciencesCompletedTotal Knee ArthroplastyLithuania
-
Changi General HospitalCompletedTotal Knee ReplacementsSingapore
-
Hospital Universitari Vall d'Hebron Research InstituteCompletedFemoral Triangle Block: Early Mobilization and Postoperative Analgesia After Total Knee ArthroplastyPain, Postoperative | Arthroplasty, Replacement, Knee | Anesthesia, Conduction | Ultrasonography, InterventionalSpain
-
Ankara UniversityRecruitingPain, Postoperative | Postoperative Pain | Anterior Cruciate Ligament InjuriesTurkey
-
Ziekenhuis Oost-LimburgCompletedAnalgesia | Total Knee ArthroplastyBelgium
-
Centre hospitalier de l'Université de Montréal...Completed
-
Alexandria UniversityNot yet recruiting