Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia

NCT05068063 | Unknown

• 1 other identifier: IPACK1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

nerve block; IPACK; femoral triangle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Post-operative static pain scores at 0 hours of arrival to PACU

  0 hours after arrival to PACU

• Post-operative static pain scores at PACU discharge

  at discharge of PACU up to 2 hours postoperatively

• Post-operative static pain scores at 6 hours of arrival to PACU

  6 hours after arrival to PACU

• Post-operative static pain scores at 12 hours of arrival to PACU

  12 hours after arrival to PACU

• Post-operative static pain scores at 24 hours of arrival to PACU

  24 hours after arrival to PACU

Study Arms (2)

Femoral Triangle + IPACK block

EXPERIMENTAL

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

Drug: Bupivacaine Injection

Femoral Triangle block

ACTIVE COMPARATOR

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

Drug: normal Saline

Interventions

Bupivacaine Injection DRUG

Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of Bupivacaine 0.25%

Femoral Triangle + IPACK block

normal Saline DRUG

Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of normal saline 0.9%

Femoral Triangle block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead
• Clinica Alemana de Santiago: collaborator

Study Sites (2)

Clinica Alemana de Santiago

Santiago, RM, Chile

ACTIVE NOT RECRUITING

Hospital Clinico Universidad de Chile

Santiago, RM, Chile

RECRUITING

Related Publications (9)

• Wilde J, Bedi A, Altchek DW. Revision anterior cruciate ligament reconstruction. Sports Health. 2014 Nov;6(6):504-18. doi: 10.1177/1941738113500910.

  PMID: 25364483 BACKGROUND

• 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.

  PMID: 19680735 BACKGROUND

• 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.

  PMID: 26938989 BACKGROUND

• 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.

  PMID: 31246607 BACKGROUND

• 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.

  PMID: 25140514 BACKGROUND

• 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.

  PMID: 31980156 BACKGROUND

• 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.

  PMID: 30640651 BACKGROUND

• 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.

  PMID: 33990439 BACKGROUND

• 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.

  PMID: 20620788 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Acute Pain; Pain, Postoperative; Knee Injuries

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andrea Gonzalez, MD

  Clinica Alemana de Santiago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian L Layera, MD

CONTACT

+562 29788221; sebastianlayera@gmail.com

Julian Aliste, MD

CONTACT

+562 29788221; julian.aliste@uchile.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 5, 2021
• Study Start: June 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 15, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)