Clinical trial NCT05068063: Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia
Official title: A Randomised Comparison Between Combined Femoral Triangle Block+IPACK Block and Femoral Triangle Block for Anterior Cruciate Ligament Reconstruction Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Acute Pain
Pain, Postoperative
Knee Injuries
Keywords: nerve block
IPACK
femoral triangle
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Clinica Alemana de Santiago
First posted: 2021-10-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-operative pain scores at 2 hours of arrival to Post Anesthesia Care Unit (PACU)
timeFrame: 2 hours after arrival to PACU
Secondary outcomes:
measure: Post-operative static pain scores at 0 hours of arrival to PACU
timeFrame: 0 hours after arrival to PACU
measure: Post-operative static pain scores at PACU discharge
timeFrame: at discharge of PACU up to 2 hours postoperatively
measure: Post-operative static pain scores at 6 hours of arrival to PACU
timeFrame: 6 hours after arrival to PACU
measure: Post-operative static pain scores at 12 hours of arrival to PACU
timeFrame: 12 hours after arrival to PACU
measure: Post-operative static pain scores at 24 hours of arrival to PACU
timeFrame: 24 hours after arrival to PACU
measure: Post-operative dynamic pain scores at 0 hours of arrival to PACU
timeFrame: 0 hours after arrival to PACU
measure: Post-operative dynamic pain scores at PACU discharge
timeFrame: at discharge of PACU up to 2 hours postoperatively
measure: Post-operative dynamic pain scores at 6 hours of arrival to PACU
timeFrame: 6 hours after arrival to PACU
measure: Post-operative dynamic pain scores at 12 hours of arrival to PACU
timeFrame: 12 hours after arrival to PACU
measure: Post-operative dynamic pain scores at 24 hours of arrival to PACU
timeFrame: 24 hours after arrival to PACU
measure: Femoral Triangle Block success assessment at 2 hours
timeFrame: 2 hours after arrival to PACU
measure: Incidence of opioid related adverse events
timeFrame: 24 hours after arrival to PACU
measure: Intraoperative opioid consumption
timeFrame: From anesthesia induction to extubation
measure: PACU opioid consumption
timeFrame: from PACU arrival to discharge up to 2 hours postoperatively
measure: Total opioid consumption
timeFrame: 6 hours, 12 hours and 24 hours after PACU arrival
measure: Nerve block complications
timeFrame: From nerve block performance up to 24 hours after PACU arrival
measure: Lower limb tourniquet
timeFrame: from inflation of pneumatic device to tourniquet release
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
state: RM
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
state: RM
Study officials:
affiliation: Clinica Alemana de Santiago
name: Andrea Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilde J, Bedi A, Altchek DW. Revision anterior cruciate ligament reconstruction. Sports Health. 2014 Nov;6(6):504-18. doi: 10.1177/1941738113500910.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.