Acute Pain, Anterior Cruciate Ligament Rupture, Knee Injuries, Pain, Postoperative
Conditions
Keywords
nerve block, IPACK, femoral triangle
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.
Interventions
DRUGBupivacaine Injection
Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of Bupivacaine 0.25%
DRUGnormal Saline
Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of normal saline 0.9%
Sponsors
Clinica Alemana de Santiago
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain scores at 2 hours of arrival to Post Anesthesia Care Unit (PACU) | 2 hours after arrival to PACU | Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative static pain scores at PACU discharge | at discharge of PACU up to 2 hours postoperatively | 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 | 6 hours after 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 | 12 hours after 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 | 24 hours after 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 | 0 hours after 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 | at discharge of PACU up to 2 hours postoperatively | 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 | 6 hours after 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 | 12 hours after arrival to PACU | Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points |
| Post-operative static pain scores at 0 hours of arrival to PACU | 0 hours after arrival to PACU | Pain evaluated at rest in Numeric Rating Score from 0 to 10 points |
| Femoral Triangle Block success assessment at 2 hours | 2 hours after arrival to PACU | Sensory block will be assessed with ice on the medial leg |
| Incidence of opioid related adverse events | 24 hours after arrival to PACU | Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression, urinary retention) |
| Intraoperative opioid consumption | From anesthesia induction to extubation | Total opioid use during intraoperative period |
| PACU opioid consumption | from PACU arrival to discharge up to 2 hours postoperatively | total opioid consumption during PACU stay |
| Total opioid consumption | 6 hours, 12 hours and 24 hours after PACU arrival | Total opioid consumption |
| Nerve block complications | From nerve block performance up to 24 hours after PACU arrival | Incidence of nerve block complications (vascular puncture, puncture site erythema, hematoma, foot drop, LAST) |
| Lower limb tourniquet | from inflation of pneumatic device to tourniquet release | lower limb tourniquet duration |
| Post-operative dynamic pain scores at 24 hours of arrival to PACU | 24 hours after arrival to PACU | Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points |
Countries
Chile
Contacts
Primary ContactSebastian L Layera, MD
Backup ContactJulian Aliste, MD
Outcome results
None listed