NCT02548104

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2023

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

6.1 years

First QC Date

September 8, 2015

Last Update Submit

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 COMPARATOR

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

Adductor canal ACB + genicular (IPACK)

EXPERIMENTAL

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

Interventions

ACBOTHER

ultrasound-guided ACB with 0.25% Bupivicaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with normal saline 15 ml

Adductor canal block (ACB)

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

Adductor canal ACB + genicular (IPACK)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Roya Yumul, M.D.,PhD.

    Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

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

Locations