Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06402110
Other study ID # 36264MS559/4/24
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 7, 2024
Est. completion date October 1, 2024

Study information

Verified date May 2024
Source Tanta University
Contact Mohammed S Elsharkawy, MD
Phone 00201148207870
Email mselsharkawy@med.tanta.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Femoral Triangle Block
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 Block
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.

Locations

Country Name City State
Egypt Tanta University Tanta El-Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 hours postoperatively
Secondary 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. 24 hours postoperatively
Secondary 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. 24 hours postoperatively
Secondary 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). 24 hours postoperatively
Secondary 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) 24 hours postoperatively
See also
  Status Clinical Trial Phase
Completed NCT06280456 - Tranexamic Acid Injection With Different Drainage Clamping Time After Anterior Cruciate Ligament Reconstruction N/A
Active, not recruiting NCT02772770 - Pediatric ACL: Understanding Treatment Options
Terminated NCT00300300 - Anterior Cruciate Ligament (ACL) Reconstruction Using Different Grafts and Surgical Techniques Phase 4
Completed NCT00775892 - SeriACLâ„¢ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair Phase 1/Phase 2
Completed NCT04504344 - Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction Phase 1
Recruiting NCT06327555 - Study on the Effect of Telerehabilitation Using Wearable Devices After ACL Reconstruction N/A
Recruiting NCT05968729 - Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol N/A
Not yet recruiting NCT05972876 - Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction N/A
Withdrawn NCT03688477 - Iovera° to Treat Pain Associated With ACL Reconstruction and Rehabilitation N/A
Completed NCT02945553 - Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery Phase 1/Phase 2
Recruiting NCT01279759 - Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction N/A
Completed NCT00245271 - Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction Phase 3
Recruiting NCT06131047 - High Intensity Resistance Training With and Without Blood Flow Restriction in ACL Reconstruction N/A
Recruiting NCT06206200 - The Effect of Cognitive Dual-task Rehabilitation on Arthrogenic Muscle Responses After ACL Reconstruction N/A
Recruiting NCT06430775 - Exploring Prolonged AMR in ACL Reconstructed Patients
Not yet recruiting NCT06318039 - Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction N/A
Recruiting NCT03336060 - Neurophysiologic Correlates of Movement Planning During Complex Jump Landing Tasks and the Role of Cognitive Function N/A
Completed NCT03304561 - The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction N/A
Not yet recruiting NCT05619393 - Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People N/A
Completed NCT02604550 - Anterior Cruciate Ligament Pain Study Phase 4