Comparison of Local Anesthetic Dose in PENG Block Performed in Total Hip Replacement Operations
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The investigators research was designed as a single-center, prospective, randomized
      double-blind study. The patients undergoing total hip replacement surgery in Istanbul
      University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be
      included. Patients or persons 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 PENG 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.

      PENG block will be done for postoperative analgesia. After the PENG block, 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. Measurements
      made at 5-minute intervals will be recorded.

      In the investigators clinic, the use of PENG 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.

      The local anesthetic solution given by the supervisor, whose doses of local anesthetic are
      predetermined (the investigators and participants do not know the dosage), with a total
      volume of 20 cc will be used. Local anesthetic agent will not be applied to the control
      group. As mentioned above, spinal anesthesia will be performed after PENG block and the
      operation will be started.

      Pain score and total morphine consumption will be determined by visual pain scoring (VAS) at
      the postoperative 0, 6, 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 VAS>4 after each interrogation, morphine 0.05 mg/kg iv will be administered as
      additional analgesia and the maximum will be increased to 10 mg. Pain management will
      continue when VAS <4.
    

Detailed description: 
      The investigators research was designed as a single-center, prospective, randomized
      double-blind study. After the approval of the Ethics Committee, the study will start and is
      aimed to be completed in 12 months.

      The patients undergoing total hip replacement surgery in Istanbul University Istanbul
      Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients or
      persons 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' Vas 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 PENG 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.

      PENG block will be done for postoperative analgesia. After the PENG block, 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. Measurements made at 5-minute intervals will be recorded.

      In the investigators clinic, the use of PENG 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.

      The local anesthetic solution given by the supervisor, whose doses of local anesthetic are
      predetermined (the investigators and participants do not know the dosage), with a total
      volume of 20 cc will be used. Local anesthetic agent will not be applied to the control
      group. As mentioned above, spinal anesthesia will be performed after PENG block and the
      operation will be started.

      Pain score and total morphine consumption will be determined by visual pain scoring (VAS) at
      the postoperative 0, 6, 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 VAS>4 after each interrogation, morphine 0.05 mg/kg iv will be administered as
      additional analgesia and the maximum will be increased to 10 mg. Pain management will
      continue when VAS <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, first mobilization time, hospitalization time, amount of morphine consumed and
      additional analgesic need, onset time of narcotic analgesic need, preoperative and
      postoperative in the first month Depression-BECK Score, quadriceps weakness, postop patient
      satisfaction and surgical satisfaction. 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 84 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 HCl 0.5 % in 20 ML Injection; Bupivacaine HCl 0.25 % in 20 ML Injection; Bupivacaine HCl 0.125 % in 20 ML Injection; NaCl 0.9%
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In this group, US guided PENG block will be performed with 20 ml 0.5% bupivacaine using a 22 gauge 10 mm block needle.; In this group, US guided PENG block will be performed with 20 ml 0.25% bupivacaine using a 22 gauge 10 mm block needle.; In this group, US guided PENG block will be performed with 20 ml 0.125% bupivacaine using a 22 gauge 10 mm block needle.; In this group, US guided PENG block will be performed with 20 ml %0.9 NaCl solution using a 22 gauge 10 mm block needle (Control Group).
Other intervention name(s): Marcaine; Marcaine; Marcaine; Saline Solution
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pericapsuler Nerve Group Block; Regional Anesthesia; Analgesic consumption; Postoperative analgesia; Numeric rating scale