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NCT Number: NCT06936995

Multimodal Analgesia vs. Femoral Block in ACL Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Faculty of Medicine

Ankara, 06230, Turkey (Türkiye)

Location status: Recruiting

Location contact

SEVDE NUR AYDIN KUŞSAN, M.D.

CONTACT

[email protected]

+905398561592

Sevde Nur AYDIN KUŞSAN, M.D.

PRINCIPAL_INVESTIGATOR

About this study

Postoperative pain following anterior cruciate ligament (ACL) reconstruction is typically acute in nature and may hinder early physiotherapy interventions. Effective postoperative pain control is essential for optimizing rehabilitation outcomes by enabling early mobilization, which can reduce the risk of thromboembolic complications, maintain pulmonary function, and mitigate metabolic and endocrine stress responses. Adequate analgesia also helps prevent the development of chronic pain, supports cognitive function, and may shorten hospital stay.

ACL injuries are commonly observed in athletes, as well as middle-aged individuals engaging in recreational activities. The success of ACL reconstruction surgery is highly dependent on early and effective postoperative rehabilitation, particularly muscle strength restoration.

Delayed mobilization following surgery may lead to muscle atrophy, cartilage degeneration, and connective tissue adhesions. Early ambulation and rehabilitation are critical for tissue healing and for maintaining joint function and mobility.

Various methods have been utilized for postoperative analgesia, including patient-controlled epidural analgesia, intravenous patient-controlled analgesia (PCA), peripheral nerve blocks, and intra-articular local anesthetic infiltration. Multimodal analgesia protocols have demonstrated superior outcomes in terms of pain control, opioid-sparing effects, and patient satisfaction when compared with single-modality approaches.

This prospective, randomized, double-blind clinical trial will compare the effects of preemptive intravenous multimodal analgesia and femoral triangle block on early postoperative rehabilitation compliance in adult patients undergoing ACL reconstruction under general anesthesia. The interventions are routinely used in clinical practice and are recognized as safe and effective.

The primary objective is to evaluate whether either approach improves compliance with early rehabilitation tasks. Compliance will be assessed using functional recovery metrics including the straight leg raise test, sit-to-stand success, and patient-reported pain scores using the Numerical Rating Scale (NRS) at predefined postoperative time points.

Secondary endpoints include total opioid consumption, frequency of opioid-related adverse events (e.g., nausea, vomiting, itching), and overall patient satisfaction. This study addresses a current gap in the literature, as no previous trials have directly compared these two methods in this clinical context.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Preemptive Multimodal Intravenous Analgesia

Drug

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

Other names: Multimodal Analgesia, IV Pain Management Protocol

Femoral Triangle Block

Procedure

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

Other names: Femoral Nerve Block Anesthesia

Primary outcomes

  1. Compliance with Straight Leg Raise Test (SLR)

    Time frame: Postoperative 2, 6, 12 and 24 hours

    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.

  2. Standing Ability

    Time frame: Postoperative 2,6,12 and 24 hours

    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.

Secondary outcomes

  1. Total Opioid Consumption

    Time frame: Postoperative 2, 6, 12, 24, 48, and 72 hours

    The total amount of opioids consumed by the patients in the first 72 hours after surgery will be recorded and compared between the two groups.

  2. Incidence of Opioid-Related Side Effects

    Time frame: Postoperative 2, 6, 12, 24, 48, and 72 hours

    The incidence of opioid-related side effects, such as nausea, vomiting, and itching, will be recorded and compared between the two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

SEVDE NUR AYDIN KUŞSAN, Research Assistant

CONTACT

[email protected]

+905398561592

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Comparison of Preemptive Multimodal Analgesia and Femoral Triangle Block on Early Rehabilitation in ACL Reconstruction: A Prospective, Randomized, Double-Blind Study

Acronym: MAPvsFTB

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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