- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07683078
Effect of Adding Vastus Medialis Nerve Block to Adductor Canal Block After Anterior Cruciate Ligament Reconstruction (VAMA)
Effect of Adding Vastus Medialis Nerve Block to Adductor Canal Block on Postoperative Analgesia Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
Anterior cruciate ligament (ACL) reconstruction is frequently associated with moderate to severe postoperative pain, which can delay mobilization and rehabilitation. The adductor canal block (ACB) is widely used for postoperative pain management because it provides effective analgesia while preserving quadriceps muscle strength. However, pain originating from the medial aspect of the knee may not be adequately controlled with ACB alone because the nerve to the vastus medialis may not be consistently anesthetized.
This prospective randomized controlled trial evaluates whether adding a vastus medialis nerve block (VMNB) to a standard adductor canal block improves postoperative pain control in patients undergoing elective arthroscopic ACL reconstruction. Participants are randomly assigned to receive either ACB alone or ACB combined with VMNB before surgery, while all patients receive the same standardized general anesthesia, surgical technique, and postoperative analgesic regimen.
The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, time to first mobilization, length of hospital stay, and block-related complications. The results of this study may help determine whether the addition of a vastus medialis nerve block provides clinically meaningful benefits and may contribute to improving postoperative pain management following ACL reconstruction.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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ABD Dışında
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Istanbul, ABD Dışında, Turkey (Türkiye), 34400
- SBU Bagcilar Education and Training Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 65 years.
- Scheduled for elective primary arthroscopic anterior cruciate ligament (ACL) reconstruction.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Ability to provide written informed consent.
Exclusion Criteria:
- Previous surgery on the ipsilateral knee.
- Bilateral knee surgery.
- Coagulopathy or ongoing anticoagulant therapy contraindicating regional anesthesia.
- Peripheral neuropathy or neuromuscular disease.
- Local infection at the block injection site.
- Known allergy or hypersensitivity to amide local anesthetics.
- Contraindication to regional anesthesia.
- Refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Adductor Canal Block
Participants received an ultrasound-guided adductor canal block before elective arthroscopic anterior cruciate ligament reconstruction.
All participants received standardized general anesthesia and postoperative analgesic management.
|
An ultrasound-guided adductor canal block was performed before induction of general anesthesia using 15-20 mL of 0.25% bupivacaine as part of the multimodal analgesia protocol for anterior cruciate ligament reconstruction.
|
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Active Comparator: Adductor Canal Block Plus Vastus Medialis Nerve Block
Participants received an ultrasound-guided adductor canal block combined with an ultrasound-guided vastus medialis nerve block before elective arthroscopic anterior cruciate ligament reconstruction.
All participants received standardized general anesthesia and postoperative analgesic management.
|
An ultrasound-guided adductor canal block was performed before induction of general anesthesia using 15-20 mL of 0.25% bupivacaine as part of the multimodal analgesia protocol for anterior cruciate ligament reconstruction.
An ultrasound-guided vastus medialis nerve block was performed before induction of general anesthesia using 5-10 mL of 0.25% bupivacaine in addition to the adductor canal block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity
Time Frame: 24 hours after surgery
|
Postoperative pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS) at rest at 1, 6, 12, and 24 hours after surgery.
VAS scores range from 0 (no pain) to 10 (worst imaginable pain).
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Opioid Consumption
Time Frame: 24 hours after surgery
|
Total opioid consumption during the first 24 postoperative hours will be calculated as intravenous morphine equivalent dose (mg).
|
24 hours after surgery
|
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Time to First Mobilization
Time Frame: 24 hours after surgery
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Time from completion of surgery to the patient's first successful ambulation, recorded in hours.
|
24 hours after surgery
|
|
Length of Hospital Stay
Time Frame: 24 hours after surgery
|
Length of postoperative hospital stay measured in hours from the end of surgery until hospital discharge.
|
24 hours after surgery
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Postoperative Complications
- Pathologic Processes
- Leg Injuries
- Knee Injuries
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Anterior Cruciate Ligament Injuries
- Pain, Postoperative
- Socioeconomic Factors
- Population Characteristics
- Demography
- Family Characteristics
- Marital Status
- Single Person
Other Study ID Numbers
- 681433
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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