Multimodal Analgesia vs. Femoral Block in ACL Surgery

NCT06936995 | Recruiting

• 1 other identifier: MFT_01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effects of a preemptive multimodal intravenous analgesia protocol and a femoral triangle block on early postoperative rehabilitation compliance in patients undergoing anterior cruciate ligament (ACL) reconstruction under general anesthesia. Adult patients aged 18 to 65 will be randomized to receive either multimodal intravenous analgesia or femoral triangle block prior to surgery. Rehabilitation compliance will be evaluated using the straight leg raise test, sit-to-stand success, and pain scores at multiple postoperative time points. Secondary outcomes include opioid consumption, incidence of opioid-related side effects.

Conditions

Anterior Cruciate Ligament Injuries; Postoperative Pain; Pain, Postoperative

Keywords

Anterior Cruciate Ligament (ACL) Reconstruction; Postoperative Pain Management; Multimodal Analgesia; Femoral Triangle Block; Rehabilitation Outcomes; Postoperative Recovery

Outcome Measures

Primary Outcomes (2)

• Compliance with Straight Leg Raise Test (SLR)

  This outcome measure evaluates the patients' ability to perform the straight leg raise test (SLR) at various postoperative time points. The NRS (Numeric Rating Scale) score will be used to assess the pain during these activities. NRS (Numeric Rating Scale) for pain during the activity. Scale: 0 (no pain) to 10 (worst pain). Higher scores on the NRS indicate worse pain.

  Postoperative 2, 6, 12 and 24 hours

• Standing Ability

  This outcome measure evaluates the patients' ability to stand after surgery at various postoperative time points. The NRS (Numeric Rating Scale) score will be used to assess the pain during these activities. NRS (Numeric Rating Scale) for pain during the activity. Scale: 0 (no pain) to 10 (worst pain). Higher scores on the NRS indicate worse pain.

  Postoperative 2,6,12 and 24 hours

Secondary Outcomes (2)

• Total Opioid Consumption

  Postoperative 2, 6, 12, 24, 48, and 72 hours

• Incidence of Opioid-Related Side Effects

  Postoperative 2, 6, 12, 24, 48, and 72 hours

Study Arms (2)

Preemptive Multimodal Intravenous Analgesia

ACTIVE COMPARATOR

Preemptive multimodal intravenous analgesia protocol, combining opioids, NSAIDs, and adjunctive medications to manage postoperative pain.

Drug: Preemptive Multimodal Intravenous Analgesia

Femoral Triangle Blok

EXPERIMENTAL

Femoral triangle block, a regional anesthesia technique, to manage postoperative pain by injecting a local anesthetic around the femoral nerve at the femoral triangle point.

Procedure: Femoral Triangle Block

Interventions

Preemptive Multimodal Intravenous Analgesia DRUG

Combination of opioids, NSAIDs, and adjunctive medications to manage postoperative pain before and during surgery.

Also known as: Multimodal Analgesia, IV Pain Management Protocol

Preemptive Multimodal Intravenous Analgesia

Femoral Triangle Block PROCEDURE

Local anesthetic injection around the femoral nerve to manage postoperative pain via regional anesthesia.

Also known as: Femoral Nerve Block Anesthesia

Femoral Triangle Blok

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years or older. Condition: Patients scheduled for anterior cruciate ligament (ACL) reconstruction surgery.
• ASA Classification: Patients classified as ASA I, II, or III. Orientation: Patients who are fully oriented and can cooperate with study procedures.
• Consent: Patients capable of providing informed consent to participate in the study.

You may not qualify if:

• Informed Consent: Patients unable to provide informed consent. BMI: Patients with a BMI of ≥30 kg/m². Allergy: Known allergy to local anesthetics. Orientation and Cooperation: Patients who are not fully oriented or cannot cooperate with study procedures.
• Additional Trauma: Patients with other traumatic injuries requiring opioid analgesia.
• Neuropathic Pain History: Patients with a history of neuropathic pain. Chronic Pain Syndrome: Patients with a history of chronic pain syndrome.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Pain, Postoperative

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• MENEKŞE ÖZÇELİK

  Ankara University

  STUDY DIRECTOR

Central Study Contacts

SEVDE NUR AYDIN KUŞSAN, Research Assistant

CONTACT

+905398561592; sevdenuraydiiin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study will be double-blind, meaning neither the researchers nor the participants will know which treatment group they belong to, ensuring unbiased outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, randomized, double-blind clinical trial with parallel assignment. Participants will be randomized into two groups to compare the effects of preemptive intravenous multimodal analgesia versus femoral triangle block on early postoperative rehabilitation compliance and pain control following ACL reconstruction surgery.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 20, 2025
• Study Start: January 21, 2025
• Primary Completion: November 25, 2025
• Study Completion: January 20, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)