Analgesic Efficacy of Anterior Femoral, Genicular and Adductor Canal Nerve Block

August 28, 2023 updated by: Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Randomized, Double-Blinded Study to Evaluate the Analgesic Efficacy of Anterior Femoral Cutaneous Nerve Block and/or Genicular Nerve Block When Combined With Adductor Canal (Saphenous) Nerve Block After Total Knee Arthroplasty

Recently, more distal approach to femoral nerve branches (saphenous) in the adductor canal in the medial compartment of the thigh have shown to provide comparable anesthesia and analgesia without quadriceps muscle weakness than traditional femoral nerve blocks (FNB) after total knee arthroplasty (TKA). Adductor canal block (ACB) has the unique advantage of providing localized analgesia to the peripatellar and intra-articular aspects of the knee joint without reducing the patient's ability to perform a straight leg raise. However, it does not adequately address the incisional pain component on the anterior surface of the knee innervated by anterior femoral cutaneous nerve. This pain may be improved by addition of the anterior femoral block (AFB). Additionally, the ACB does not provide analgesia to the posterior aspect of the knee, which is commonly moderate to severe after surgery. This pain may be decreased by addition of the genicular block, also known as the iPACK block (interspace between the popliteal artery and the capsule of the knee). There is no study that has evaluated the potentially analgesic benefits of the AFB or the iPACK block combined with ACB after TKA. Therefore, the investigators designed this randomized, prospective, and double-blinded study to assess our hypothesis that the addition of the AFB and/or iPACK block to the ACB will improve analgesic effects, decrease pain scores, deceased opioid requirement, and as well as facilitate early recovery and improve patient satisfaction with pain management in patient after TKA.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain associated with total knee arthroplasty (TKA) can pose significant challenges in the recovery process of the patients undergoing this procedure. Traditionally, opioids have played a significant role in treating postoperative pain. It is well established that opioids are highly effective in relieving pain at rest, but are less effective in relieving pain associated with motion (e.g. ambulation, passive motion, and physical rehabilitation). Furthermore, the use of opioids for analgesia is associated with well-known side effects (such as: nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus, drowsiness, sedation, and allergic reaction). These opioid side effects, which range in severity, can significantly interfere with the rehabilitation process and contribute to a delay in hospital discharge.

Significant interest exists in the application of regional anesthetic techniques as an adjuvant to traditional opioid analgesics for pain control in patients after TKA. Specifically, the incorporation of femoral nerve blocks (FNB) as an adjunct in postoperative pain control has been widely reported in the anesthesia literature. While it has shown to be effective in post-operative pain control, it has introduced additional challenges for physical therapy and raised new concerns regarding the associated quadriceps muscle weakness. Until adequate quadriceps function returns, the need for knee immobilization devices to protect patients with traditional FNB from falls interferes with the early recovery process and the achievement of physical therapy milestones.

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-90 yrs
  2. The American Society of Anesthesiologists (ASA) Physical Status 1-3
  3. Either gender

Exclusion Criteria:

  1. Refusal to participate in the study
  2. Age< 18 yrs, or> 90 yrs
  3. General anesthesia
  4. Bilateral TKA, or revision of TKA

  5. Contraindications to regional blockage including but not limited to:

    • Patient refusal to regional blockade
    • Infection at the site of needle insertion
    • Systemic infection
    • Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory evaluation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adductor canal block (ACB)
Group I Adductor canal block (ACB): 0.25% bupivacaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with normal saline 15 ml
Other: ACB
ultrasound-guided ACB with 0.25% Bupivicaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with normal saline 15 ml
Experimental: Adductor canal ACB + genicular (IPACK)
Group II Adductor canal block (ACB): 0.25% bupivacaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with 0.25% Bupivicaine with 1:200,000 epinephrine 15 ml
Other: ACB + iPACK
ultrasound-guided ACB with 0.25% Bupivicaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with 0.25% Bupivicaine with 1:200,000 epinephrine 15 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of pain scores (VRS) at rest
Time Frame: Post-op day 1,2,3
Verbal rating scale (VRS) scores: 0 = none to 10 = intolerable pain.
Post-op day 1,2,3
Changes of pain scores (VRS) at motion activity
Time Frame: Post-op day 1,2,3
Verbal rating scale (VRS) scores: 0 = none to 10 = intolerable pain.
Post-op day 1,2,3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction score
Time Frame: Post-op day 1
(0-very dissatisfied to 10 very satisfied)
Post-op day 1
Patient satisfaction score
Time Frame: Post-op day 2
(0-very dissatisfied to 10 very satisfied)
Post-op day 2
Patient satisfaction score
Time Frame: Post-op day 3
(0-very dissatisfied to 10 very satisfied)
Post-op day 3
Gait distance
Time Frame: Post-op day 1
(feet)
Post-op day 1
Gait distance
Time Frame: Post-op day 2
(feet)
Post-op day 2
Gait distance
Time Frame: Post-op day 3
(feet)
Post-op day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Roya Yumul, M.D.,PhD., Department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Estimated)

October 14, 2024

Study Completion (Estimated)

October 14, 2024

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimated)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMCPro00034213

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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