Comparing Adductor Canal Block and Adductor Canal Block-Local Infiltration Analgesia for Post-operative Pain Management

Comparison of the Effectiveness of Adductor Canal Block Versus Combination of Adductor Canal Block and Local Infiltration Analgesia: A Randomized Controlled Trial of the Effect on Postoperative Analgesia and Motor Power

Anterior cruciate ligament (ACL) reconstruction is one of the most commonly performed surgeries amongst young orthopedic surgery patients. Optimal post-operative pain control helps to reduce the opioid burden and to improve the patient's experience. Regional anesthesia, such as the femoral nerve block (FNB) and adductor canal block (ACB), are commonly used for post-operative pain control after surgery. The ACB has replaced the FNB. This is because the ACB targets the femoral nerve, while avoiding the numbing effects on quadricep muscle strength that make it difficult to move the leg. Another form of pain control is local infiltration anesthesia (LIA), which directly blocks pain in the knee. Similar to the ACB, it avoids the numbing effects on the quadricep muscle.This can help improve patient safety and experience by reducing risks of falls and allowing the patient to move earlier. This can also be associated with decreased time in the hospital and decreased costs. Technically, it is less complex and can be done the shorter period of time.

The purpose of this study is to refine the pain management technique following anterior cruciate ligament surgery. More specifically, the aim of this study is to evaluate the effects of LIA alone, and a LIA-ACB combination on post-operative pain and thigh muscle strength.

Study Overview

• Status: Unknown
• Conditions: ACL; ACL Injury; ACL Tear
• Intervention / Treatment: Procedure: Local Infiltration Anesthetic; Procedure: Local Infiltration Anesthetic + Adductor Canal Block

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• English speaking or any other language with possibility of adequate translation
• ASA I-III patients
• Age 18-50
• BMI ≤ 38 kg/m2

Exclusion Criteria:

• Refusal or inability to provide informed consent
• Any contraindication to regional anesthesia including coagulopathy or bleeding diathesis,
• Allergy to local anesthetics, or infection at the site of the block
• History of long-term opioid intake (more than 3 months use) or chronic pain disorder (more than 3 months)
• History of preexisting neuropathy in the operative leg
• Revision of ACL repair

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Local Infiltration Anesthetic; This group of patients will receive the local infiltration anesthetic only.	Procedure: Local Infiltration Anesthetic; For the local infiltration anesthetic, patients will receive 20 cc of 0.5% ropivacaine, by intra-articular injection performed by the surgeon. The injection is done at the end of the surgical procedure, after suturing the incision.
EXPERIMENTAL: Local Infiltration Anesthetic + Adductor Canal Block; This group of patients will receive the local infiltration anesthetic and adductor canal block combination.	Procedure: Local Infiltration Anesthetic + Adductor Canal Block; For the local infiltration anesthetic, patients will receive 20 cc of 0.25% ropivacaine, by intra-articular injection performed by the surgeon. The injection is done at the end of the surgical procedure, after suturing the incision. For the adductor canal block, patients will receive 20 cc of 0.25% ropivicaine, through injection performed by the anesthesiologist. The injection is done under the sartorius muscle, in mid-thigh, using ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral morphine equivalent consumption	Cumulative oral morphine equivalent consumption over 24 hours post-op	Up to 24-hours after surgery
Quadriceps motor strength	Percent decrease in quadriceps motor strength at 30 minutes following anesthesia compared to baseline	Pre-op, 30 minutes post-anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inta-operative opioid consumption	Cumulative amount of opioids consumed during surgery	during surgery
Oral morphine equivalent consumption in PACU	Cumulative oral morphine equivalent consumed in PACU	PACU admission to PACU discharge (approximately 4 hours)
Post-operative Pain	area under the curve for rest pain scores during the first 24 hours post-op, using the numeric pain rating scale from 0-10, with 0 being no pain and 10 being the worst possible pain	Up to 24 hours post-operative
Quality of Recovery	Measured using the QoR-15 questionnaire at 24 hours post-op	At 24 hours post-operative
Time in hospital	Time from admission to discharge	From hospital admission to hospital discharge (approximately 12 hours)
Nerve Block Complications	Presence or absence of nerve block complications	up to 24 hours post-operative, up to 2 weeks post-operative

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): November 1, 2021

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (ACTUAL): January 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2382

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No