Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia

Study Overview
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Brief Summary
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An adequate balance between analgesia and motor function is an essential requirement to facilitate functional recovery and early discharge after anterior cruciate ligament (ACL) reconstruction surgery. Proximal nerve blocks (i.e. femoral and sciatic nerve blocks) are associated with optimal analgesia, but they can cause muscle weakness, interfering with rehabilitation and increasing the risk of falls . A recent randomized controlled trial concluded that, compared to mid-and distal ACB, a distal femoral triangle block (FTB) is associated with lower opioid consumption and improved postoperative analgesia for ambulatory ACL reconstruction. In ACL reconstruction surgery there are other potential sources of pain not covered by a FTB, such as intra-articular structures (menisci, cruciate ligaments), posterior knee capsule and the graft donor site. Evidence supporting the addition of an IPACK block to a FTB has been studied for patients undergoing total knee replacement, nonetheless, there is no trial analyzing the analgesic contribution of IPACK to a FTB in the context of ACL reconstruction surgery. In this multicentric trial, the investigators set out to analyze the analgesic benefit of adding an IPACK block to a FTB.

Official Title
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A Randomised Comparison Between Combined Femoral Triangle Block+IPACK Block and Femoral Triangle Block for Anterior Cruciate Ligament Reconstruction Analgesia

Conditions
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Acute Pain, Anterior Cruciate Ligament Rupture, Pain, Postoperative, Knee Injuries

Intervention / Treatment
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* Drug: Bupivacaine Injection
* Drug: normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled to undergo anterior cruciate ligament reconstruction under general anesthesia with ipsilateral autologous graft. Age between 18 and 65 years American Society of Anesthesiologists classification 1-3 Body mass index between 19 and 35 (kg/m2) Exclusion Criteria: Adults who are unable to give their own consent Pre-existing neuropathy (assessed by history and physical examination) Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50) Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) Allergy to local anesthetics (LAs), morphine or tramadol Pregnancy ACL revision surgery Contralateral graft or any type of allograft Chronic pain syndromes requiring opioid intake at home

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femoral Triangle + IPACK block<br>Patients randomized to receive a combination of femoral triangle block and active IPACK block | Drug: Bupivacaine Injection<br>* Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of Bupivacaine 0.25%<br>|
| Active Comparator: Femoral Triangle block<br>Patients randomized to receive a combination of femoral triangle block and sham IPACK block | Drug: normal Saline<br>* Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of normal saline 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain scores at 2 hours of arrival to Post Anesthesia Care Unit (PACU) | Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points | 2 hours after arrival to PACU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative static pain scores at 0 hours of arrival to PACU | Pain evaluated at rest in Numeric Rating Score from 0 to 10 points | 0 hours after arrival to PACU | 
| Post-operative static pain scores at PACU discharge | Pain evaluated at rest in Numeric Rating Score from 0 to 10 points | at discharge of PACU up to 2 hours postoperatively | 
| Post-operative static pain scores at 6 hours of arrival to PACU | Pain evaluated at rest in Numeric Rating Score from 0 to 10 points | 6 hours after arrival to PACU | 
| Post-operative static pain scores at 12 hours of arrival to PACU | Pain evaluated at rest in Numeric Rating Score from 0 to 10 points | 12 hours after arrival to PACU | 
| Post-operative static pain scores at 24 hours of arrival to PACU | Pain evaluated at rest in Numeric Rating Score from 0 to 10 points | 24 hours after arrival to PACU | 
| Post-operative dynamic pain scores at 0 hours of arrival to PACU | Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points | 0 hours after arrival to PACU | 
| Post-operative dynamic pain scores at PACU discharge | Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points | at discharge of PACU up to 2 hours postoperatively | 
| Post-operative dynamic pain scores at 6 hours of arrival to PACU | Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points | 6 hours after arrival to PACU | 
| Post-operative dynamic pain scores at 12 hours of arrival to PACU | Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points | 12 hours after arrival to PACU | 
| Post-operative dynamic pain scores at 24 hours of arrival to PACU | Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points | 24 hours after arrival to PACU | 
| Femoral Triangle Block success assessment at 2 hours | Sensory block will be assessed with ice on the medial leg | 2 hours after arrival to PACU | 
| Incidence of opioid related adverse events | Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression, urinary retention) | 24 hours after arrival to PACU | 
| Intraoperative opioid consumption | Total opioid use during intraoperative period | From anesthesia induction to extubation | 
| PACU opioid consumption | total opioid consumption during PACU stay | from PACU arrival to discharge up to 2 hours postoperatively | 
| Total opioid consumption | Total opioid consumption | 6 hours, 12 hours and 24 hours after PACU arrival | 
| Nerve block complications | Incidence of nerve block complications (vascular puncture, puncture site erythema, hematoma, foot drop, LAST) | From nerve block performance up to 24 hours after PACU arrival | 
| Lower limb tourniquet | lower limb tourniquet duration | from inflation of pneumatic device to tourniquet release | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nerve block, IPACK, femoral triangle