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Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia

Primary Purpose

Anterior Cruciate Ligament Rupture, Acute Pain, Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Bupivacaine Injection
normal Saline
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring nerve block, IPACK, femoral triangle

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica Alemana de Santiago
  • Hospital Clinico Universidad de ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Femoral Triangle + IPACK block

Femoral Triangle block

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2021
Last Updated
June 3, 2022
Sponsor
University of Chile
Collaborators
Clinica Alemana de Santiago
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1. Study Identification

Unique Protocol Identification Number
NCT05068063
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
October 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Clinica Alemana de Santiago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture, Acute Pain, Pain, Postoperative, Knee Injuries
Keywords
nerve block, IPACK, femoral triangle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Femoral Triangle + IPACK block
Arm Type
Experimental
Arm Description
Patients randomized to receive a combination of femoral triangle block and active IPACK block
Arm Title
Femoral Triangle block
Arm Type
Active Comparator
Arm Description
Patients randomized to receive a combination of femoral triangle block and sham IPACK block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Intervention Description
Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of Bupivacaine 0.25%
Intervention Type
Drug
Intervention Name(s)
normal Saline
Intervention Description
Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of normal saline 0.9%
Primary Outcome Measure Information:
Title
Post-operative pain scores at 2 hours of arrival to Post Anesthesia Care Unit (PACU)
Description
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Time Frame
2 hours after arrival to PACU
Secondary Outcome Measure Information:
Title
Post-operative static pain scores at 0 hours of arrival to PACU
Description
Pain evaluated at rest in Numeric Rating Score from 0 to 10 points
Time Frame
0 hours after arrival to PACU
Title
Post-operative static pain scores at PACU discharge
Description
Pain evaluated at rest in Numeric Rating Score from 0 to 10 points
Time Frame
at discharge of PACU up to 2 hours postoperatively
Title
Post-operative static pain scores at 6 hours of arrival to PACU
Description
Pain evaluated at rest in Numeric Rating Score from 0 to 10 points
Time Frame
6 hours after arrival to PACU
Title
Post-operative static pain scores at 12 hours of arrival to PACU
Description
Pain evaluated at rest in Numeric Rating Score from 0 to 10 points
Time Frame
12 hours after arrival to PACU
Title
Post-operative static pain scores at 24 hours of arrival to PACU
Description
Pain evaluated at rest in Numeric Rating Score from 0 to 10 points
Time Frame
24 hours after arrival to PACU
Title
Post-operative dynamic pain scores at 0 hours of arrival to PACU
Description
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Time Frame
0 hours after arrival to PACU
Title
Post-operative dynamic pain scores at PACU discharge
Description
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Time Frame
at discharge of PACU up to 2 hours postoperatively
Title
Post-operative dynamic pain scores at 6 hours of arrival to PACU
Description
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Time Frame
6 hours after arrival to PACU
Title
Post-operative dynamic pain scores at 12 hours of arrival to PACU
Description
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Time Frame
12 hours after arrival to PACU
Title
Post-operative dynamic pain scores at 24 hours of arrival to PACU
Description
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
Time Frame
24 hours after arrival to PACU
Title
Femoral Triangle Block success assessment at 2 hours
Description
Sensory block will be assessed with ice on the medial leg
Time Frame
2 hours after arrival to PACU
Title
Incidence of opioid related adverse events
Description
Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression, urinary retention)
Time Frame
24 hours after arrival to PACU
Title
Intraoperative opioid consumption
Description
Total opioid use during intraoperative period
Time Frame
From anesthesia induction to extubation
Title
PACU opioid consumption
Description
total opioid consumption during PACU stay
Time Frame
from PACU arrival to discharge up to 2 hours postoperatively
Title
Total opioid consumption
Description
Total opioid consumption
Time Frame
6 hours, 12 hours and 24 hours after PACU arrival
Title
Nerve block complications
Description
Incidence of nerve block complications (vascular puncture, puncture site erythema, hematoma, foot drop, LAST)
Time Frame
From nerve block performance up to 24 hours after PACU arrival
Title
Lower limb tourniquet
Description
lower limb tourniquet duration
Time Frame
from inflation of pneumatic device to tourniquet release

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian L Layera, MD
Phone
+562 29788221
Email
sebastianlayera@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Julian Aliste, MD
Phone
+562 29788221
Email
julian.aliste@uchile.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Gonzalez, MD
Organizational Affiliation
Clinica Alemana de Santiago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Alemana de Santiago
City
Santiago
State/Province
RM
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinico Universidad de Chile
City
Santiago
State/Province
RM
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian L Layera, MD
Phone
+562 29788221
Email
sebastianlayera@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25364483
Citation
Wilde J, Bedi A, Altchek DW. Revision anterior cruciate ligament reconstruction. Sports Health. 2014 Nov;6(6):504-18. doi: 10.1177/1941738113500910.
Results Reference
background
PubMed Identifier
19680735
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.
Results Reference
background
PubMed Identifier
26938989
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.
Results Reference
background
PubMed Identifier
31246607
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.
Results Reference
background
PubMed Identifier
25140514
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.
Results Reference
background
PubMed Identifier
31980156
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.
Results Reference
background
PubMed Identifier
30640651
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.
Results Reference
background
PubMed Identifier
33990439
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.
Results Reference
background
PubMed Identifier
20620788
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.
Results Reference
background

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Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia

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