Pain, PostoperativeNCT02548104
Analgesic Efficacy of Anterior Femoral, Genicular and Adductor Canal Nerve Block
A study testing ACB and ACB + iPACK in people with Pain, Postoperative, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ACB and ACB + iPACK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 6 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90 yrs
- The American Society of Anesthesiologists (ASA) Physical Status 1-3
- Either gender
Who cannot join
- 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
Show all 9Show fewer
- Infection at the site of needle insertion
- Systemic infection
- Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory evaluation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
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
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- ACB, ACB + iPACK
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
ACB + iPACKOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: ACB + iPACK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of pain scores (VRS) at rest
Verbal rating scale (VRS) scores: 0 = none to 10 = intolerable pain.
Measured: 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.
Measured: Post-op day 1,2,3
Secondary outcomes (6)
Patient satisfaction score
(0-very dissatisfied to 10 very satisfied)
Measured: Post-op day 1
Patient satisfaction score
(0-very dissatisfied to 10 very satisfied)
Measured: Post-op day 2
Patient satisfaction score
(0-very dissatisfied to 10 very satisfied)
Measured: Post-op day 3
Gait distance
(feet)
Measured: Post-op day 1
Gait distance
(feet)
Measured: Post-op day 2
Gait distance
(feet)
Measured: Post-op day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study start1 Oct 2017
- Primary completion6 Nov 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Tang, MD, Cedars-Sinai Medical Center
- Investigators
- Roya Yumul, M.D.,PhD., Principal investigator, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548104
- Sponsor's protocol ID
- CSMCPro00034213
- Status last verified
- Jun 2025
- First submitted
- 8 Sep 2015
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02548104
- Acronym / sponsor ID
- CSMCPro00034213
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block (ACB) | Active comparator | Other: ACBGroup 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) | Experimental | Other: ACB + iPACKGroup 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-90 yrs
- The American Society of Anesthesiologists (ASA) Physical Status 1-3
- Either gender
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACBultrasound-guided ACB with 0.25% Bupivicaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with normal saline 15 ml | Other | Adductor canal block (ACB) |
| ACB + iPACKultrasound-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 | Other | Adductor canal ACB + genicular (IPACK) |
Primary outcome
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.
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.
6 secondary outcomes
Patient satisfaction score
Time frame: Post-op day 1
Patient satisfaction score
Time frame: Post-op day 2
Patient satisfaction score
Time frame: Post-op day 3
Gait distance
Time frame: Post-op day 1
Gait distance
Time frame: Post-op day 2
Gait distance
Time frame: Post-op day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roya Yumul, M.D.,PhD. principal investigator
Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACB and ACB + iPACK in people with Pain, Postoperative, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of pain scores (VRS) at rest (time frame: Post-op day 1,2,3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.