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Osteo Arthritis KneeNCT04931966

Comparision of IPACK and Periarticular Block With Adductor Block Alone After Total Knee Artroplasty

A study testing block, adductor canal block and Adductor Canal Block plus IPACK Block in people with Osteo Arthritis Knee, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

105 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of three groups, namely group A (n=35), where an adductor canal block, group B (N:35) where an adductor canal block with IPCAK, and group C (n=35) where an adductor canal block with PAI will be… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
block, adductor canal block and Adductor Canal Block plus IPACK Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Jun 2021to 17 Aug 2021
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 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Physical status according to American Society of Anesthesiologists (ASA) I-III
  • Patients scheduled for total knee arthroplasty

Who cannot join

  • Previous operation on same knee
  • Hepatic or renal insufficiency
  • Younger than 18 years old and older than 85
  • Patients undergoing general anesthesia
  • Allergy or intolerance to one of the study medications
  • BMI > 40
Show all 9Show fewer
  • ASA IV
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Karaman Training and Research Hospital

    Karaman, 70200

Other trials in Turkey (Türkiye)

About this study

Official title: Comparision of IPACK and Periarticular Block With Adductor Block Alone After Total Knee Artroplasty: a Prospective Randomized Trial on Pain and Knee Function After Total Knee Artroplasty

105 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of three groups, namely group A (n=35), where an adductor canal block, group B (N:35) where an adductor canal block with IPCAK, and group C (n=35) where an adductor canal block with PAI will be performed preoperatively. All patients will receive a standardized multimodal approach. NRS scores will be evaluated in static and dynamic conditions during the first 48 hours postoperatively.

Read the detailed description

Total knee replacement (TKP) is accepted as one of the major orthopedic surgery that most patients suffer from pain in the postoperative period. The primary aim of this research is to compare the analgesic efficacy of infiltration between the popliteal artery and capsule of the knee(IPACK) with the periarticular block when an additional adductor canal block is used. In the literature, adductor canal block(ACB) and sciatic nerve block are used as part of multimodal analgesia for postoperative pain management of patients undergoing TKP. Nevertheless, ACB is found less effective for pain originating from the posterior part of the knee. Sciatic nerve block and periarticular injection(PAI) are commonly used blocks to improve the analgesic effect of ACB. Besides this, ACB is effective for pain originated from the posterior part of the knee. IPACK block is performed under ultrasound guidance and targets the articular branches of tibial, common peroneal, and obturator nerves with sparing lower extremity motor function.

Patients scheduled for knee surgery under spinal anesthesia are included fort his study. All groups will be applied 0.03 mg/kg midazolam iv, then spinal anesthesia will be applied to 15 mg 0.5 % heavy bupivacaine. Three groups of 105 patients will be included in the study.

Adductor Canal Block (ACB) (Group A ) (n:35): After the patients are given the supine position, under the guidance of the ultrasound linear probe, 10-15cm proximal to the knee joint, under the sartorius muscle, next to the femoral artery. After the saphenous is observed, 0.25% 20 mL of bupivacaine will be given

Adductor + İPACK Grup ( group B) (n: 35): Adductor canal 0.25% 20 mL of bupivacaine will be administered. After the knee is flexed, after the convex probe is placed in the popliteal space, 20 ml of 0.25% bupivacaine will be injected into the area between the popliteal artery and the femur called IPACK

Adductor + PAI ( group C) (n: 35): Adductor canal 0.25% 20 mL of bupivacaine will be administered. Patients will receive 60 ml of local anesthetic cocktail intraoperatively by the surgeon. At the end of the operation to the peri-articular area (posterior capsule, collateral ligament, quadriceps muscle). Cocktail consists of 40 ml 0.25% bupivacaine + 8 ml 8 mg morphine+12 ml saline.

Routine multimodal analgesia will be used for postoperative analgesia

Being tested
block, adductor canal block, Adductor Canal Block plus IPACK Block, adductor Canal Block plus PAI Block
Keywords
Total knee arthroplasty, Peri articular infiltration, Ipack block, Adductor canal block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blockProcedure or surgery

    Adductor canal block

  • adductor canal blockProcedure or surgery

    adductor canal block bupivacain

  • Adductor Canal Block plus IPACK BlockProcedure or surgery

    Adductor Canal Block plus IPACK Block using bupivacaine

  • adductor Canal Block plus PAI BlockProcedure or surgery

    Adductor Canal Block plus PAI Block using bupivacaine

Study groups in NCT04931966
Study groupRoleWhat they receive
Group AActive comparatorAdductor canal block
Receives: Procedure: block; Procedure: adductor canal block
Group BActive comparatorAdductor canal block plus IPACK
Receives: Procedure: block; Procedure: adductor canal block; Procedure: Adductor Canal Block plus IPACK Block
Group CActive comparatorAdductor canal block plus PAI
Receives: Procedure: block; Procedure: adductor canal block; Procedure: adductor Canal Block plus PAI Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NRS scores

    Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)

    Measured: 48 hours

Secondary outcomes (7)

  1. Opioid consumption

    Analgesic consumption at 4-6-8-12-24 and 48 hours

    Measured: 4-6-8-12-24 and 48 hours

  2. Range of knee motion

    Degrees of flexion

    Measured: 48 hours

  3. Complications

    Complications

    Measured: 48 hours

  4. Patient satisfaction

    Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No

    Measured: 48 hours

  5. Incidence of adverse events related to nerve block procedures

    muscle weakness, systemic toxicity

    Measured: Post-op 24 to 72 hours

  6. Rate of postoperative nausea and vomiting

    nausea, vomiting

    Measured: Post-op 24 to 48 hours

  7. Patient mobilization

    Patient reporting time of first standing to the side of the bed and time up and go test 2 days

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start22 Jun 2021
  3. Primary completion8 Aug 2021
  4. Study completion17 Aug 2021

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04931966
Sponsor's protocol ID
02-202l/04:
Status last verified
Aug 2021
First submitted
9 Jun 2021
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kertkiatkachorn W, Kampitak W, Tanavalee A, Ngarmukos S. Adductor Canal Block Combined With iPACK (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block vs Periarticular Injection for Analgesia After Total Knee Arthroplasty: A Randomized Noninferiority Trial. J Arthroplasty. 2021 Jan;36(1):122-129.e1. doi: 10.1016/j.arth.2020.06.086. Epub 2020 Jul 2.

    PubMed 32694032

  • Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.

    PubMed 30234517

Questions about this trial

What is this clinical trial studying?

A study testing block, adductor canal block and Adductor Canal Block plus IPACK Block in people with Osteo Arthritis Knee, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).

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 2 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 18 Aug 2021. 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 Turkey (Türkiye). 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?

NRS scores (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04931966, which also lists 2 linked publications.

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 18 Aug 2021.

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