Analgesic Efficacy of Anterior Femoral, Genicular and Adductor Canal Nerve Block
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
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
September 14, 2015
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2023
CompletedJune 19, 2025
June 1, 2025
6.1 years
September 8, 2015
June 16, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Changes of pain scores (VRS) at rest
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
Verbal rating scale (VRS) scores: 0 = none to 10 = intolerable pain.
Post-op day 1,2,3
Secondary Outcomes (6)
Patient satisfaction score
Post-op day 1
Patient satisfaction score
Post-op day 2
Patient satisfaction score
Post-op day 3
Gait distance
Post-op day 1
Gait distance
Post-op day 2
- +1 more secondary outcomes
Study Arms (2)
Adductor canal block (ACB)
ACTIVE COMPARATORGroup 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
Adductor canal ACB + genicular (IPACK)
EXPERIMENTALGroup 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
Interventions
ultrasound-guided ACB with 0.25% Bupivicaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with normal saline 15 ml
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
Eligibility Criteria
You may qualify if:
- Age 18-90 yrs
- The American Society of Anesthesiologists (ASA) Physical Status 1-3
- Either gender
You may not qualify if:
- Refusal to participate in the study
- Age\< 18 yrs, or\> 90 yrs
- General anesthesia
- Bilateral TKA, or revision of TKA
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roya Yumul, M.D.,PhD.
Department of Anesthesiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of anesthesiology
Study Record Dates
First Submitted
September 8, 2015
First Posted
September 14, 2015
Study Start
October 1, 2017
Primary Completion
November 6, 2023
Study Completion
November 6, 2023
Last Updated
June 19, 2025
Record last verified: 2025-06