Anterior Cruciate Ligament InjuriesMAPvsFTBNCT06936995
Multimodal Analgesia vs. Femoral Block in ACL Surgery
A study testing Preemptive Multimodal Intravenous Analgesia and Femoral Triangle Block in people with Anterior Cruciate Ligament Injuries and Postoperative Pain, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Postoperative Pain, Pain, Postoperative
- What is being tested?
- Preemptive Multimodal Intravenous Analgesia and Femoral Triangle Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Faculty of Medicine
Ankara, 06230
SEVDE NUR AYDIN KUŞSAN, M.D., +905398561592, sevdenuraydiiin@gmail.com
Sevde Nur AYDIN KUŞSAN, M.D.
About this study
Official title: 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.
Read the 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.
- Being tested
- Preemptive Multimodal Intravenous Analgesia, Femoral Triangle Block
- Keywords
- Anterior Cruciate Ligament (ACL) Reconstruction, Postoperative Pain Management, Multimodal Analgesia, Femoral Triangle Block, Rehabilitation Outcomes, Postoperative Recovery
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemptive Multimodal Intravenous AnalgesiaDrug
Also called Multimodal Analgesia, IV Pain Management Protocol
Combination of opioids, NSAIDs, and adjunctive medications to manage postoperative pain before and during surgery.
Femoral Triangle BlockProcedure or surgery
Also called Femoral Nerve Block Anesthesia
Local anesthetic injection around the femoral nerve to manage postoperative pain via regional anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Preemptive Multimodal Intravenous Analgesia | Active comparator | Preemptive multimodal intravenous analgesia protocol, combining opioids, NSAIDs, and adjunctive medications to manage postoperative pain. Receives: 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. Receives: Procedure: Femoral Triangle Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postoperative 2,6,12 and 24 hours
Secondary outcomes (2)
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.
Measured: 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.
Measured: Postoperative 2, 6, 12, 24, 48, and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start21 Jan 2025
- Primary completion25 Nov 2025 (estimated)
- Study completion20 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEVDE NUR AYDIN KUSSAN, Ankara University
- Investigators
- MENEKŞE ÖZÇELİK, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936995
- Sponsor's protocol ID
- MFT_01
- Acronym
- MAPvsFTB
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preemptive Multimodal Analgesia and Femoral Triangle Block on Early Rehabilitation in ACL Reconstruction: A Prospective, Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT06936995
- Acronym / sponsor ID
- MAPvsFTB / MFT_01
- Keywords
- Anterior Cruciate Ligament (ACL) Reconstruction, Postoperative Pain Management, Multimodal Analgesia, Femoral Triangle Block, Rehabilitation Outcomes, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 25 Nov 2025 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Preemptive Multimodal Intravenous Analgesia | Active comparator | Drug: Preemptive Multimodal Intravenous AnalgesiaPreemptive multimodal intravenous analgesia protocol, combining opioids, NSAIDs, and adjunctive medications to manage postoperative pain. |
| Femoral Triangle Blok | Experimental | Procedure: Femoral Triangle BlockFemoral triangle block, a regional anesthesia technique, to manage postoperative pain by injecting a local anesthetic around the femoral nerve at the femoral triangle point. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preemptive Multimodal Intravenous AnalgesiaAlso: Multimodal Analgesia, IV Pain Management ProtocolCombination of opioids, NSAIDs, and adjunctive medications to manage postoperative pain before and during surgery. | Drug | Preemptive Multimodal Intravenous Analgesia |
| Femoral Triangle BlockAlso: Femoral Nerve Block AnesthesiaLocal anesthetic injection around the femoral nerve to manage postoperative pain via regional anesthesia. | Procedure or surgery | Femoral Triangle Blok |
Primary outcome
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.
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.
2 secondary outcomes
Total Opioid Consumption
Time frame: Postoperative 2, 6, 12, 24, 48, and 72 hours
Incidence of Opioid-Related Side Effects
Time frame: Postoperative 2, 6, 12, 24, 48, and 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MENEKŞE ÖZÇELİK study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preemptive Multimodal Intravenous Analgesia and Femoral Triangle Block in people with Anterior Cruciate Ligament Injuries and Postoperative Pain, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEVDE NUR AYDIN KUŞSAN, Research Assistant (+905398561592, sevdenuraydiiin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with Straight Leg Raise Test (SLR) (time frame: Postoperative 2, 6, 12 and 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.