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| Name | Class |
|---|---|
| Clinica Alemana de Santiago | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral Triangle + IPACK block | Experimental | Patients randomized to receive a combination of femoral triangle block and active IPACK block |
|
| Femoral Triangle block | Active Comparator | Patients randomized to receive a combination of femoral triangle block and sham IPACK block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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% |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian L Layera, MD | Contact | +562 29788221 | sebastianlayera@gmail.com | |
| Julian Aliste, MD | Contact | +562 29788221 | julian.aliste@uchile.cl |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Gonzalez, MD | Clinica Alemana de Santiago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Alemana de Santiago | Active, not recruiting | Santiago | RM | Chile | ||
| Hospital Clinico Universidad de Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25364483 | Background | Wilde J, Bedi A, Altchek DW. Revision anterior cruciate ligament reconstruction. Sports Health. 2014 Nov;6(6):504-18. doi: 10.1177/1941738113500910. | |
| 19680735 | 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. |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 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% |
|
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 |
| Recruiting |
| Santiago |
| RM |
| Chile |
|
| 26938989 | 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. |
| 31246607 | 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. |
| 25140514 | 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. |
| 31980156 | 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. |
| 30640651 | 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. |
| 33990439 | 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. |
| 20620788 | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |