Peri-articular Injection and (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.
Condition: Postoperative Pain; Regional Anesthesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This is a prospective randomized double blind controlled study to evaluate the post-operative
      analgesic effect of adductor canal block (ACB) or peri-articular injection (PAIs) compared to
      combined adductor canal block and infiltration of the interspace between popliteal artery and
      the capsule of posterior knee block ( IPACK) in patient undergoing total knee arthroplasty
    

Detailed description: 
      This prospective randomized study will be carried out in Tanta University Hospitals in
      Anesthesia Department for one year after approval from ethical committee of faculty of
      medicine of Tanta university. After approval from institutional ethics committee, an informed
      consent will be taken from each patient. All data of the patients will be confidential with
      secret codes and private file for each patient, all given data will be used for the current
      medical research only. Any unexpected risks encountered during the course of the research
      will be cleared to the participants as well as to the Ethical Committee on time. Every
      patient will receive an explanation to the purpose of the study and every patient will have a
      secret code number to ensure privacy to participants and confidentiality of data.

      Inclusion criteria:

      Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for
      elective Total knee arthroplasty will be enrolled in the study.

      Exclusion criteria:

        -  Patient who refuse the regional anesthesia technique.

        -  History of allergy to local anesthetics.

        -  Local infection at the site of the block.

        -  Patients with bleeding and coagulation disorders.

        -  Patient with Advanced renal, hepatic and cardiac diseases.

        -  Preexisting lower extremity neurological abnormality, or neuropathy and difficulties in
           comprehending (NRS).

      Grouping and Allocation:

      60 patients will be enrolled in this study in each group, Patients will be randomly
      classified into three equal groups (20 patients each).

      Randomization will be done by computer generated numbers into:

      Group (I): 20 patients will receive adductor canal block alone. Group (II): 20 Patients will
      receive peri-articular injection alone. Group (III): 20 patients will receive adductor canal
      block (ACB) and infiltration of the interspace between popliteal artery and the capsule of
      posterior knee block (IPACK).

      Anesthetic technique:

      Preoperative assessment will be done by:

      History talking, clinical examination, routine laboratory investigations including CBC,
      coagulation profile, random blood sugar, liver and renal function tests. During the
      pre-anesthetic assessment, all patients will be familiarized with Numeric Rating Scale (NRS)
      score. On entering the operating room, intravenous line (IV) will be inserted, routine
      monitoring of heart rate by ECG, noninvasive blood pressure (NIBP), pulse oximetry will be
      done. All patients will receive spinal anesthesia with 3 ml 0.5% (15 mg) hyperbaric
      bupivacaine plus 25 μgm fentanyl at the L3/4 interspaces and the study of regional anesthetic
      technique will be performed postoperatively according to each group. All patients will
      receive postoperative analgesic regimen which is paracetamol 1gm intravenously every 8 hours
      and ketorolac 30mg every12 hours. Rescue analgesia in the form of 0.05 mg/kg of morphine IV
      will be administrated when the Numeric Rating Score (NRS) exceeding 3. The morphine dose will
      be repeated whenever indicated considering the total dose in the first 24 hours never
      exceeding 20 mg.

      Measurements:

        1. Demographic data (age, gender, weight, ASA classification).

        2. Post-operative pain will be assessed by Numeric Rating Scale (NRS) from 0 to 10 at
           0,2,4,6 then every 6h for 24 hours and in the second and third postoperative days at
           rest and during Physiotherapy.

        3. Postoperative analgesia, which will be assessed by total analgesic consumption, and time
           till administration of first rescue analgesia will be recorded.

        4. Effect on Motor function: by recording the mean time taken to achieve 90o active knee
           flexion each day till the third postoperative day.

        5. Adverse effects: hypotension, Bradycardia, infection, hematoma and local anesthetic
           toxicity will be observed and treated accordingly.
    

Intervention name(s): Adductor canal block (ACB) group; Peri-articular injection group; Adductor canal block and IPACK block group
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal; Patients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon.
A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL; Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized controlled study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: peri-articular injection; adductor canal block; IPACK; Total knee arthroplasty