Femoral Triangle + IPACK Blocks for ACL Reconstruction Analgesia

Sponsor

University of Chile (Other)

Overall Status

Recruiting

CT.gov ID

NCT05068063

Collaborator

Clinica Alemana de Santiago (Other)

Enrollment

Locations

Arms

4.5

Anticipated Duration (Months)

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Rupture Acute Pain Pain, Postoperative Knee Injuries	Drug: Bupivacaine Injection Drug: normal Saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Femoral Triangle + IPACK block Patients randomized to receive a combination of femoral triangle block and active IPACK block	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%
Active Comparator: Femoral Triangle block Patients randomized to receive a combination of femoral triangle block and sham IPACK block	Drug: 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%

Arm

Intervention/Treatment

Experimental: Femoral Triangle + IPACK block

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

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%

Active Comparator: Femoral Triangle block

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

Drug: 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%

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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