Analgesic Efficacy of Anterior Femoral, Genicular and Adductor Canal Nerve Block
Primary Purpose
Pain, Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACB
ACB + iPACK
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Age 18-90 yrs
- The American Society of Anesthesiologists (ASA) Physical Status 1-3
- Either gender
Exclusion Criteria:
- 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)
Sites / Locations
- Cedars Sinai Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Adductor canal block (ACB)
Adductor canal ACB + genicular (IPACK)
Arm Description
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
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
Outcomes
Primary Outcome Measures
Changes of pain scores (VRS) at rest
Verbal rating scale (VRS) scores: 0 = none to 10 = intolerable pain.
Changes of pain scores (VRS) at motion activity
Verbal rating scale (VRS) scores: 0 = none to 10 = intolerable pain.
Secondary Outcome Measures
Patient satisfaction score
(0-very dissatisfied to 10 very satisfied)
Patient satisfaction score
(0-very dissatisfied to 10 very satisfied)
Patient satisfaction score
(0-very dissatisfied to 10 very satisfied)
Gait distance
(feet)
Gait distance
(feet)
Gait distance
(feet)
Full Information
NCT ID
NCT02548104
First Posted
September 8, 2015
Last Updated
August 28, 2023
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02548104
Brief Title
Analgesic Efficacy of Anterior Femoral, Genicular and Adductor Canal Nerve Block
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 14, 2024 (Anticipated)
Study Completion Date
October 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adductor canal block (ACB)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Adductor canal ACB + genicular (IPACK)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
ACB
Intervention Description
ultrasound-guided ACB with 0.25% Bupivicaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with normal saline 15 ml
Intervention Type
Other
Intervention Name(s)
ACB + iPACK
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes of pain scores (VRS) at rest
Description
Verbal rating scale (VRS) scores: 0 = none to 10 = intolerable pain.
Time Frame
Post-op day 1,2,3
Title
Changes of pain scores (VRS) at motion activity
Description
Verbal rating scale (VRS) scores: 0 = none to 10 = intolerable pain.
Time Frame
Post-op day 1,2,3
Secondary Outcome Measure Information:
Title
Patient satisfaction score
Description
(0-very dissatisfied to 10 very satisfied)
Time Frame
Post-op day 1
Title
Patient satisfaction score
Description
(0-very dissatisfied to 10 very satisfied)
Time Frame
Post-op day 2
Title
Patient satisfaction score
Description
(0-very dissatisfied to 10 very satisfied)
Time Frame
Post-op day 3
Title
Gait distance
Description
(feet)
Time Frame
Post-op day 1
Title
Gait distance
Description
(feet)
Time Frame
Post-op day 2
Title
Gait distance
Description
(feet)
Time Frame
Post-op day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-90 yrs
The American Society of Anesthesiologists (ASA) Physical Status 1-3
Either gender
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roya Yumul, M.D.,PhD.
Phone
310-423-5841
Email
Roya.Yumul@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Tang, M.D.
Phone
310-423-5841
Email
tangfriend@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roya Yumul, M.D.,PhD.
Organizational Affiliation
Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roya Yumul, M.D., PhD.
Phone
310-423-5841
Email
Roya.Yumul@cshs.org
First Name & Middle Initial & Last Name & Degree
Jun Tang, M.D.
Phone
310-423-5841
Email
tangfriend@yahoo.com
12. IPD Sharing Statement
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Analgesic Efficacy of Anterior Femoral, Genicular and Adductor Canal Nerve Block
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