- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04931966
Comparision of IPACK and Periarticular Block With Adductor Block Alone After Total Knee Artroplasty
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
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Karaman, Turkey, 70200
- Karaman Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Physical status according to American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for total knee arthroplasty
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group A
Adductor canal block
|
Adductor canal block
adductor canal block bupivacain
|
ACTIVE_COMPARATOR: Group B
Adductor canal block plus IPACK
|
Adductor canal block
adductor canal block bupivacain
Adductor Canal Block plus IPACK Block using bupivacaine
|
ACTIVE_COMPARATOR: Group C
Adductor canal block plus PAI
|
Adductor canal block
adductor canal block bupivacain
Adductor Canal Block plus PAI Block using bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NRS scores
Time Frame: 48 hours
|
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events related to nerve block procedures
Time Frame: Post-op 24 to 72 hours
|
muscle weakness, systemic toxicity
|
Post-op 24 to 72 hours
|
Patient satisfaction
Time Frame: 48 hours
|
Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
|
48 hours
|
Range of knee motion
Time Frame: 48 hours
|
Degrees of flexion
|
48 hours
|
Opioid consumption
Time Frame: 4-6-8-12-24 and 48 hours
|
Analgesic consumption at 4-6-8-12-24 and 48 hours
|
4-6-8-12-24 and 48 hours
|
Complications
Time Frame: 48 hours
|
Complications
|
48 hours
|
Rate of postoperative nausea and vomiting
Time Frame: Post-op 24 to 48 hours
|
nausea, vomiting
|
Post-op 24 to 48 hours
|
Patient mobilization
Time Frame: 2 days
|
Patient reporting time of first standing to the side of the bed and time up and go test 2 days
|
2 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-202l/04:
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteo Arthritis Knee
-
University of PaviaNot yet recruitingLower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation.Osteo Arthritis Knee and Hip | Lower Limb ArthroplastyItaly
-
NHS LothianNot yet recruitingOsteo Arthritis Knee | Arthropathy of Knee | Arthritis KneeUnited Kingdom
-
Science and Research Centre KoperSlovenian Research AgencyCompletedOsteo Arthritis Knee | Knee ArthroplastySlovenia
-
Anchen Pharmaceuticals, IncNovum Pharmaceutical Research ServicesCompletedOsteo Arthritis of the KneeUnited States
-
Royal Infirmary of EdinburghUnknownOsteo Arthritis Knee | Arthroplasty, Replacement, KneeUnited Kingdom
-
Vastra Gotaland RegionActive, not recruiting
-
Smith & Nephew, Inc.Terminated
-
CorinRecruitingOsteo Arthritis Knee | Total Knee Arthroplasty | Total Knee Replacement | Knee DiseaseFrance
-
CorinActive, not recruitingOsteo Arthritis Knee | Total Knee Arthroplasty | Total Knee Replacement | Knee DiseaseFrance
-
Mostafa BahaaRecruiting
Clinical Trials on block
-
National Cancer Institute, EgyptRecruiting
-
University of FloridaUnited States Department of Defense; Brooks RehabilitationRecruiting
-
Huazhong University of Science and TechnologyRecruitingPain, Acute | Nerve Block | Thoracic AnesthesiaChina
-
Kyungpook National University HospitalCompletedPain | Radicular; Neuropathic, Cervical
-
University of PennsylvaniaAbiomed Inc.Not yet recruiting
-
Sakarya UniversityNot yet recruitingFemur Fracture | Erector Spinae | Lumbar Plexus | Ultrasound Guide
-
Makassed General HospitalRecruiting
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedVideo-assisted Thoracoscopic Surgery | Postoperative Analgesia | Thoracic Paravertebral BlockTurkey
-
Wake Forest University Health SciencesCompletedPostoperative Analgesia | Medial Unicompartmental Knee ArthroplastyUnited States
-
University of TriesteCliniche Humanitas Gavazzeni; A.O.U. Città della Salute e della Scienza - Molinette...UnknownPain, Postoperative | SAP Block Versus ESP Block | Evaluation of Locoregional Techniques | Multimodal Pain ManagementItaly