Comparison of Local Anesthetic Dose in Ipack Block Performed in Knee Arthroplasty Operations
Condition: Analgesia; Pain, Postoperative; Anesthesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The investigators research was designed as a single-center, prospective, randomized study.
      The patients undergoing knee artrhroplasty surgery in Istanbul University Istanbul Medicine
      Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally
      authorized to make decisions on their behalf will be informed about the research and their
      written consent will be obtained. Patients who do not give consent will not be included in
      the study.

      Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block
      needle after compliance with the rules of asepsia and antisepsis in the supine position
      according to the group of patients in which they were included.

      IPACK and adductor block will be done for postoperative analgesia. After then, a single dose
      of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position,
      using the appropriate spinal needle, as is routinely applied in the investigators clinic.
      After the block is completed, the pinprick test will be done and the operation will be
      started after the successful completion of the block is confirmed. Oxygen will be given to
      the patients with a face mask at 4 lt / min throughout the operation. ECG, saturation,
      invasive / noninvasive blood pressure monitoring of the patients will be done.

      In the investigators clinic, the use of IPACK block, adductor block and PCA (patient
      controlled analgesia) device with intravenous morphine for postoperative analgesia is
      routinely performed. In this study, four randomized groups will be formed together with the
      control group.

      IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd
      group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25%
      bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and
      PCA (patient controlled analgesia) device with intravenous morphine for postoperative
      analgesia is performed.

      Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at
      the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with
      intravenous morphine applied in routine practice to all four groups. As in routine practice,
      when NRS > 4 after each interrogation, morphine 2 mg iv will be administered as additional
      analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS
      < 4.
    

Detailed description: 
      The investigators research was designed as a single-center, prospective, randomized study.

      The patients undergoing knee arthroplasty in Istanbul University Istanbul Medicine Faculty
      Department of Orthopedics and Traumatology will be included. Patients who are legally
      authorized to make decisions on their behalf will be informed about the research and their
      written consent will be obtained. Patients who do not give consent will not be included in
      the study.

      Patients will be evaluated preoperative before surgery, a detailed history will be taken and
      physical examination will be carried out. Medical and surgical resume information will be
      obtained. Patients' NRS scores will be recorded before the operation. Patients will be taken
      to the operating room after premedication.

      ECG, pulse oximeter, blood pressure monitoring will be performed in the operating room.
      Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block
      needle after compliance with the rules of asepsia and antisepsis in the supine position
      according to the group of patients in which they were included.

      IPACK and adductor block will be done for postoperative analgesia. After then, a single dose
      of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position,
      using the appropriate spinal needle, as is routinely applied in the investigators clinic.
      After the block is completed, the pinprick test will be done and the operation will be
      started after the successful completion of the block is confirmed. Oxygen will be given to
      the patients with a face mask at 4 lt / min throughout the operation.ECG, saturation,
      invasive / noninvasive blood pressure monitoring of the patients will be done.

      In the investigators clinic, the use of IPACK block, adductor block and PCA (patient
      controlled analgesia) device with intravenous morphine for postoperative analgesia is
      routinely performed. In this study, four randomized groups will be formed together with the
      control group.Computer-generated random numbers will be used for simple randomization of
      patients.

      IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd
      group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25%
      bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and
      PCA (patient controlled analgesia) device with intravenous morphine for postoperative
      analgesia is performed.

      Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at
      the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with
      intravenous morphine applied in routine practice to all four groups. As in routine practice,
      when NRS > 4 after each interrogation, morphine 2 mg iv will be administered as additional
      analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS
      < 4.

      Patients are followed up in the service for 48 hours postoperatively in routine practice.

      In the postoperative period, patients will be evaluated in terms of additional nausea and
      vomiting,amount of morphine consumed and additional analgesic need postoperative period up to
      48 hours.First mobilization time, hospitalization time will be evaluated.Womac osteoarthritis
      index and joint range of motion will be evaluated at preoperative period and at the discharge
      day from the hospital.The Medical Research Council (MRC) Scale for Muscle Strength for lower
      extremity will be evaluated preoperative period, at postoperative 24th hour and at the
      discharge day from the hospital.

      Postop patient satisfaction and surgical satisfaction with Likert scale will also be
      evaluated at postoperative period.

      During the procedure, complications such as failed block, nerve damage, vascular injury,
      intravenous injection of local anesthetic, local anesthetic toxicity and allergic reactions
      will be recorded.

      Before the study, it was determined that at least 112 patients should be collected in the
      power analysis performed with the help of similar literature data. After collecting the
      demographic data and morphine consumption data of the patients, the data will be transferred
      to the statistical program called SPSS and statistical analysis will be made.The
      investigators study does not contain any modifications other than the investigators daily
      routine practices.
    

Intervention name(s): Bupivacaine; Morphine Sulfate
Intervention type(s): Drug; Drug
Intervention description(s): US guided IPACK block will be performed with 10/15/20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0,25 bupivacaine.; In this group,adductor block will be performed with 15 ml %0,25 bupivacaine using a 22 gauge 10 mm block needle and patients will be postoperatively administered patient controlled analgesia with morphine.
Other intervention name(s): Marcaine; morphine
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: IPACK block; Postoperative Pain; Postoperative Patient Controlled Analgesia; Knee Artroplasty; Regional Anesthesia; Numeric rating scale