NCT07683078

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2026

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

June 27, 2026

Last Update Submit

July 11, 2026

Conditions

Keywords

Anterior Cruciate Ligament ReconstructionAdductor Canal BlockVastus Medialis Nerve BlockRegional AnesthesiaPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity

    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 Outcomes (3)

  • Postoperative Opioid Consumption

    24 hours after surgery

  • Time to First Mobilization

    24 hours after surgery

  • Length of Hospital Stay

    24 hours after surgery

Study Arms (2)

Adductor Canal Block

ACTIVE COMPARATOR

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.

Procedure: Adductor Canal Block (ACB) Only

Adductor Canal Block Plus Vastus Medialis Nerve Block

ACTIVE COMPARATOR

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.

Procedure: Adductor Canal Block (ACB) OnlyProcedure: Vastus Medialis Nerve Block

Interventions

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.

Adductor Canal BlockAdductor Canal Block Plus Vastus Medialis Nerve Block

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.

Adductor Canal Block Plus Vastus Medialis Nerve Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBU Bagcilar Education and Training Hospital

Istanbul, ABD Dışında, 34400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesPain, Postoperative

Interventions

Single Person

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to receive either an adductor canal block alone or an adductor canal block combined with a vastus medialis nerve block before elective arthroscopic anterior cruciate ligament reconstruction. Both groups received standardized general anesthesia, perioperative care, and postoperative analgesic management.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 27, 2026

First Posted

July 6, 2026

Study Start

March 14, 2026

Primary Completion

July 4, 2026

Study Completion

July 11, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Locations