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

Osteo Arthritis Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931966
• Other study ID #: 02-202l/04:
• Status: Completed
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: August 17, 2021

Study information

• Verified date: August 2021
• Source: Karaman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 17, 2021
• Est. primary completion date: August 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• block
Adductor canal block
• adductor canal block
adductor canal block bupivacain
• Adductor Canal Block plus IPACK Block
Adductor Canal Block plus IPACK Block using bupivacaine
• adductor Canal Block plus PAI Block
Adductor Canal Block plus PAI Block using bupivacaine

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS scores	Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)	48 hours
Secondary	Opioid consumption	Analgesic consumption at 4-6-8-12-24 and 48 hours	4-6-8-12-24 and 48 hours
Secondary	Range of knee motion	Degrees of flexion	48 hours
Secondary	Complications	Complications	48 hours
Secondary	Patient satisfaction	Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No	48 hours
Secondary	Incidence of adverse events related to nerve block procedures	muscle weakness, systemic toxicity	Post-op 24 to 72 hours
Secondary	Rate of postoperative nausea and vomiting	nausea, vomiting	Post-op 24 to 48 hours
Secondary	Patient mobilization	Patient reporting time of first standing to the side of the bed and time up and go test 2 days	2 days