Multimodal Analgesia vs. Femoral Block in ACL Surgery (MAPvsFTB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Postoperative Pain; Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Drug: Preemptive Multimodal Intravenous Analgesia; Procedure: Femoral Triangle Block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SEVDE NUR AYDIN KUŞSAN, Research Assistant; Phone Number: +905398561592; Email: sevdenuraydiiin@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Recruiting
    • Ankara University Faculty of Medicine
    • Contact: SEVDE NUR AYDIN KUŞSAN, M.D.; Phone Number: +905398561592; Email: sevdenuraydiiin@gmail.com
    • Contact: Sevde Nur AYDIN KUŞSAN, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preemptive Multimodal Intravenous Analgesia; Preemptive multimodal intravenous analgesia protocol, combining opioids, NSAIDs, and adjunctive medications to manage postoperative pain.	Drug: Preemptive Multimodal Intravenous Analgesia; Combination of opioids, NSAIDs, and adjunctive medications to manage postoperative pain before and during surgery.; Other Names: Multimodal Analgesia; IV Pain Management Protocol
Experimental: Femoral Triangle Blok; 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; Local anesthetic injection around the femoral nerve to manage postoperative pain via regional anesthesia.; Other Names: Femoral Nerve Block Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption	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.	Postoperative 2, 6, 12, 24, 48, and 72 hours
Incidence of Opioid-Related Side Effects	The incidence of opioid-related side effects, such as nausea, vomiting, and itching, will be recorded and compared between the two groups.	Postoperative 2, 6, 12, 24, 48, and 72 hours

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Study Director: MENEKŞE ÖZÇELİK, Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Estimated): November 25, 2025
• Study Completion (Estimated): January 20, 2026

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Pain Management; Postoperative Recovery; Multimodal Analgesia; Anterior Cruciate Ligament (ACL) Reconstruction; Femoral Triangle Block; Rehabilitation Outcomes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Pain, Postoperative
• Other Study ID Numbers: MFT_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No