Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Anterior Cruciate Ligament Rupture; Knee Injuries; Acute Pain
• Intervention / Treatment: Drug: Bupivacaine Injection; Drug: normal Saline

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian L Layera, MD; Phone Number: +562 29788221; Email: sebastianlayera@gmail.com
• Study Contact Backup: Name: Julian Aliste, MD; Phone Number: +562 29788221; Email: julian.aliste@uchile.cl

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile
      • Active, not recruiting
      • Clinica Alemana de Santiago
    • Santiago, RM, Chile
      • Recruiting
      • Hospital Clínico Universidad de Chile
      • Contact: Sebastian L Layera, MD; Phone Number: +562 29788221; Email: sebastianlayera@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Clinica Alemana de Santiago
• Investigators: Principal Investigator: Andrea Gonzalez, MD, Clinica Alemana de Santiago

Publications and helpful links

General Publications

• Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045.
• Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.
• Wilde J, Bedi A, Altchek DW. Revision anterior cruciate ligament reconstruction. Sports Health. 2014 Nov;6(6):504-18. doi: 10.1177/1941738113500910.
• Abdallah FW, Mejia J, Prasad GA, Moga R, Chahal J, Theodoropulos J, Dwyer T, Brull R. Opioid- and Motor-sparing with Proximal, Mid-, and Distal Locations for Adductor Canal Block in Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial. Anesthesiology. 2019 Sep;131(3):619-629. doi: 10.1097/ALN.0000000000002817.
• Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.
• Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21.
• Johnston DF, Black ND, Cowden R, Turbitt L, Taylor S. Spread of dye injectate in the distal femoral triangle versus the distal adductor canal: a cadaveric study. Reg Anesth Pain Med. 2019 Jan;44(1):39-45. doi: 10.1136/rapm-2018-000002.
• Chan E, Howle R, Onwochei D, Desai N. Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. Reg Anesth Pain Med. 2021 Sep;46(9):784-805. doi: 10.1136/rapm-2021-102681. Epub 2021 May 14. Review.
• Bushnell BD, Sakryd G, Noonan TJ. Hamstring donor-site block: evaluation of pain control after anterior cruciate ligament reconstruction. Arthroscopy. 2010 Jul;26(7):894-900. doi: 10.1016/j.arthro.2009.11.022. Epub 2010 May 13.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): October 15, 2022

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 26, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: nerve block; IPACK; femoral triangle
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Pain, Postoperative; Rupture; Acute Pain; Knee Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IPACK1

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