Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068063
• Other study ID #: IPACK1
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: October 15, 2022

Study information

• Verified date: June 2022
• Source: University of Chile
• Contact: Sebastian L Layera, MD
• Phone: +562 29788221
• Email: sebastianlayera[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 15, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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%
• 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%

Locations

Country	Name	City	State
Chile	Clinica Alemana de Santiago	Santiago	RM
Chile	Hospital Clinico Universidad de Chile	Santiago	RM

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Clinica Alemana de Santiago

Country where clinical trial is conducted

Chile, 

References & Publications (9)

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. — View 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. — View Citation

Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Børglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Intraoperative opioid consumption	Total opioid use during intraoperative period	From anesthesia induction to extubation
Secondary	PACU opioid consumption	total opioid consumption during PACU stay	from PACU arrival to discharge up to 2 hours postoperatively
Secondary	Total opioid consumption	Total opioid consumption	6 hours, 12 hours and 24 hours after PACU arrival
Secondary	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
Secondary	Lower limb tourniquet	lower limb tourniquet duration	from inflation of pneumatic device to tourniquet release