Comparison of Analgesic Efficacy of ESP Block and Caudal Block in Patients Undergoing Hypospadias Surgery
Condition: Post Operative Pain; Hypospadias
MeSH terms: Hypospadias; Pain, Postoperative
Study type: Interventional

Summary: 
      The goal of clinical trial is to compare in of analgesic efficacy of sacrale erector spinae
      plane block and caudal block in patients undergoing hypospadias surgery.We will include
      children between the ages of 6 months and 7 years in the 1st and 2nd categories in the ASA.

      In our study, we seek answers to the following questions:

        -  Which of the sacral erector spinae plane block and caudal block applied to patients
           undergoing hypospadias surgery has higher postoperative analgesic efficiency than the
           other?

        -  Which of the sacral erector spinae plane block and caudal block applied to patients
           undergoing hypospadias surgery is superior in duration of analgesia? After general
           anesthesia is administered to the participants, one of the 2 blocks will be administered
           in a randomized manner and the relevant data will be recorded.Our research will be
           conducted in a single center as a prospective randomized controlled study. It was
           planned to include 60 patients from the ASA I-II pediatric patient group aged between 6
           months and 7 years, who will undergo hypospadias surgery in our hospital between
           December 2022-December 2023, and randomization will be done by closed envelope method.
           Two groups with sacral ESP and caudal block will be formed, each with 30 patients.
    

Detailed description: 
      Our research will be conducted in a prospective randomized controlled in a single center. In
      our hospital December 2022-December 2023 aged 6 months to 7 years period will be applied to
      hypospadias surgery, ASA I-II pediatric patient in the group with 60 patients included in the
      study randomisation was planned to be made and to be sealed. Two groups will be formed in
      which sacral ESP and caudal block are applied so that there will be 30 patients in each.
      Patients will be randomized into 2 groups, using the sealed envelope technique based on
      computer-generated randomized numbers.

      The study was planned to be performed as a double blind. User sacral ESP and caudal block
      will be administered by an anesthesiologist not responsible for the perioperative and
      postoperative management of the patients. A second anesthesiologist, who will be in charge of
      patient monitoring and data recording, will be unaware of the patients' group assignments.
      Additionally, parents, surgeons, and other personnel involved in the data collection process
      will be unaware of the group to which the child is assigned. Surgeons will not be present in
      the operating room while the anesthesiologist administers the block (sacral ESP block or
      caudal block). All patients will undergo aseptic skin preparation using Betadine. Since
      bandages will be applied to two points, the actual injection site will not be known.

      The age, height, weight, gender and ASA (American Society of Anaesthesiology) scores of the
      patients in both groups will be recorded.

      After the patients are taken to the operation table, standard monitoring will be performed.
      Patients's heart rate (HR), mean arterial pressure (OAB), body temperature, peripheral oxygen
      saturation (SpO2) will be monitored and anaesthesia before induction (basal value), before
      surgical incision, after surgical incision, before awakening, postoperative 5. - 30. min
      values will be recorded.

      All patients will be placed in an IV cannula using 8% sevoflurane in 50/50 O2 / air for 2 - 4
      minutes with a face mask, followed by induction of inhaled anesthesia. All patients will be
      placed in I-gel (supraglottic airway vehicle) by performing routine induction of general
      anesthesia with propofol 2-3 mg kg-1, fentanyl 1 mcg kg-1 and appropriate height for weight.
      Patients will be taken to artificial respiration support and tidal volume will be set to 8-
      10 ml/kg and minute breathing will be set to 16-26. The end tidal carbon dioxide will be kept
      between 35-40 mmHg. Anesthesia maintenance will be provided with a starting dose of
      sevoflurane 2% and IV remifentanil 0.05 mcg kg-1 min-1 with a flow of 3 Lt min-1, an O₂/air
      mixture. >20% increase in intraoperative heart rate will be evaluated as pain and
      remifentanil dose will be increased and the need for remifentanil used intraoperatively will
      be recorded.

      Group ESP (n=30) patients will be given a lateral decubitus position under general anesthesia
      before the operation and sacral ESP block will be performed accompanied by ultrasound. Group
      C (n=30) patients who will undergo caudal block will also be given a lateral decubitus
      position and ultrasound-guided block will be performed.

      After block applications 15. min surgery will be initiated. All operations will be performed
      by the same experienced team with the same surgical technique.

      Near the end of the operation, 15 mg kg-1 IV paracetamol will be given. At the end of the
      operation, the duration of operation will be recorded.

      Patients after surgery 5. minutes and 30. minutes and 1. ,2. ,4. ,6. ,12. ,24. on the hours
      the pain scoring system Face, Legs, Activity, Cry, Consolability (FLACC) will be recorded.

      At the end of the operation, the time until the time when there is a need for analgesia will
      be evaluated as "the first need for analgesia (hour)".

      Total amount of additional analgesia (oral paracetamol, mg), amount of rescue analgesia (oral
      ibuprofen, mg), patient relative satisfaction (1-Not satisfied, 2-Satisfied, 3-Very
      satisfied) will be recorded.

      Motor weakness, neurological deficit, urinary retention, nausea, vomiting, hypotension,
      bradycardia, itching, local anesthetic toxicity and bleeding that may occur in patients were
      planned to be recorded.
    

Intervention name(s): SACRAL ESP AND CAUDAL BLOCK
Intervention type(s): Procedure
Intervention description(s): Application of ultrasound-guided sacral erector spinae plane (ESP) block or ultrasound-guided caudal block with 1mL/kg 0.25% bupivacaine (local anesthetic) to patients
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Our research will be conducted in a single center as a prospective randomized controlled study. It was planned to include 60 patients from the ASA I-II pediatric patient group aged between 6 months and 7 years, who will undergo hypospadias surgery in our hospital between December 2022 and December 2023, and randomization will be done by closed envelope method. Two groups with sacral ESP and caudal block will be formed, each with 30 patients.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: sacral erector spinae plane block; caudal block; hypospadias; pediatric surgery