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

• Sponsor: Karaman Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04931966
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 57.1

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Osteo Arthritis Knee	Procedure: block; Procedure: adductor canal block; Procedure: Adductor Canal Block plus IPACK Block; Procedure: adductor Canal Block plus PAI Block	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 22, 2021
• Actual Primary Completion Date: Aug 8, 2021
• Actual Study Completion Date: Aug 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A Adductor canal block	Procedure: block; Adductor canal block; Procedure: adductor canal block; adductor canal block bupivacain
Active Comparator: Group B Adductor canal block plus IPACK	Procedure: block; Adductor canal block; Procedure: adductor canal block; adductor canal block bupivacain; Procedure: Adductor Canal Block plus IPACK Block; Adductor Canal Block plus IPACK Block using bupivacaine
Active Comparator: Group C Adductor canal block plus PAI	Procedure: block; Adductor canal block; Procedure: adductor canal block; adductor canal block bupivacain; Procedure: adductor Canal Block plus PAI Block; Adductor Canal Block plus PAI Block using bupivacaine

Outcome Measures

Primary Outcome Measures

1. NRS scores [48 hours]

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

Secondary Outcome Measures

1. Opioid consumption [4-6-8-12-24 and 48 hours]

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

2. Range of knee motion [48 hours]

   Degrees of flexion

3. Complications [48 hours]

   Complications

4. Patient satisfaction [48 hours]

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

5. Incidence of adverse events related to nerve block procedures [Post-op 24 to 72 hours]

   muscle weakness, systemic toxicity

6. Rate of postoperative nausea and vomiting [Post-op 24 to 48 hours]

   nausea, vomiting

7. Patient mobilization [2 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karaman Training and Research Hospital	Karaman		Turkey	70200

Sponsors and Collaborators

• Karaman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.

• Responsible Party: Karaman Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04931966
• Other Study ID Numbers: 02-202l/04:
• First Posted: Jun 18, 2021
• Last Update Posted: Aug 18, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Karaman Training and Research Hospital: Total knee arthroplasty; Peri articular infiltration; Ipack block; Adductor canal block
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Aug 18, 2021