Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia

Not Applicable

• Conditions: Anterior Cruciate Ligament Rupture; Knee Injuries; Acute Pain; Pain, Postoperative
• Interventions: Drug: Bupivacaine Injection; Drug: normal Saline

• Registration Number: NCT05068063
• Lead Sponsor: University of Chile

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-26
• Study First Posted: 2021-10-05
• Status Verified: 2022-06
• Study Start: 2022-06-01
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-08
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral Triangle + IPACK block	Bupivacaine Injection	Patients randomized to receive a combination of femoral triangle block and active IPACK block
Femoral Triangle block	normal Saline	Patients randomized to receive a combination of femoral triangle block and sham IPACK block

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Clinica Alemana de Santiago; 🇨🇱 Santiago, RM, Chile

Hospital Clinico Universidad de Chile; 🇨🇱 Santiago, RM, Chile