Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia

University of Chile

Status: Enrolling

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

Treatments: Drug: normal Saline; Drug: Bupivacaine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05068063

IPACK1

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Femoral Triangle + IPACK block

Experimental group

Description:

Patients randomized to receive a combination of femoral triangle block and active IPACK block

Treatment:

Drug: Bupivacaine Injection

Femoral Triangle block

Active Comparator group

Description:

Patients randomized to receive a combination of femoral triangle block and sham IPACK block

Treatment:

Drug: normal Saline