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

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04721119
Collaborator
(none)
100
2
9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Local Infiltration Anesthetic
  • Procedure: Local Infiltration Anesthetic + Adductor Canal Block
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Oral morphine equivalent consumption [Up to 24-hours after surgery]

    Cumulative oral morphine equivalent consumption over 24 hours post-op

  2. Quadriceps motor strength [Pre-op, 30 minutes post-anesthesia]

    Percent decrease in quadriceps motor strength at 30 minutes following anesthesia compared to baseline

Secondary Outcome Measures

  1. inta-operative opioid consumption [during surgery]

    Cumulative amount of opioids consumed during surgery

  2. Oral morphine equivalent consumption in PACU [PACU admission to PACU discharge (approximately 4 hours)]

    Cumulative oral morphine equivalent consumed in PACU

  3. Post-operative Pain [Up to 24 hours post-operative]

    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

  4. Quality of Recovery [At 24 hours post-operative]

    Measured using the QoR-15 questionnaire at 24 hours post-op

  5. Time in hospital [From hospital admission to hospital discharge (approximately 12 hours)]

    Time from admission to discharge

  6. Nerve Block Complications [up to 24 hours post-operative, up to 2 weeks post-operative]

    Presence or absence of nerve block complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ottawa Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT04721119
Other Study ID Numbers:
  • 2382
First Posted:
Jan 22, 2021
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 22, 2021