Intermittent Epidural Bolus Versus Epidural Infusion for Posterior Spinal Fusion After Adolescent Idiopathic Scoliosis
Condition: Pain
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Patient-controlled Intermittent epidural bolus versus epidural infusion for posterior spinal
      fusion after adolescent idiopathic scoliosis.

      Scoliosis surgery is commonly performed in adolescent due to idiopathic scoliosis. It is
      reported that the postoperative pain after scoliosis surgery that occurs due to Surgical
      trauma and severe reflex muscle spasm be severe and excruciating. There are many methods for
      postoperative pain management. It is used often opioid , paracetamol and non-steroidal
      anti-inflammatory drug with patient- controlled intravenous analgesia (IV-PCA). In addition;
      intrathecal opioids, one catheter epidural with intermittent dosing bolus of morphine or
      continuous infusion (either opioids or local anaesthetics or both), double epidural catheter
      with continuous infusion and intravenous ketamine infusion were preferred other postoperative
      pain management models.

      Epidural analgesia is accepted procedure with the efficacy and safety profile for
      postoperative pain management in major orthopedic surgery including scoliosis surgery.
      Epidural analgesia techniques commonly have been used in continuous infusion of local
      anesthetics with or without opioid. It was emphasized that there was not adequate data in the
      literature to provide argument concerning the use of epidural opioids after spinal surgery.
      The objective of this study was to compare the effects and side effects patient- controlled
      intermittent bolus epidural analgesia (PCIEA) and patient- controlled continuous epidural
      analgesia (PCCEA) with morphine for postoperative pain control in adolescent idiopathic
      scoliosis after posterior spinal fusion.

      Methods The study was conducted after obtaining written consent from all patients and
      guardian, approval from the Inonu University Faculty of Medicine Ethics Committee. This
      prospective randomized controlled double-blinded study was conducted 47 patient between 8-18
      years, American Society of Anesthesia Classification (ASA) I-II, with idiopathic scoliosis,
      scheduled for elective posterior spinal fusion.

      Patients with a history of allergy to the drugs used in the study protocol, drug abused ,
      preoperative neurologic deficit, inability to use a visual analogue scale, pulmonary, cardiac
      and neuropsychiatric disorders were excluded. Exclusion criteria during the study were
      accidental perforation of dura, faulty epidural catheter placement, postoperative neurologic
      deficit or uncontrollable nausea, vomiting and pruritus.

      The patients who were not premedicated were instructed on the visual analog scale (VAS) and
      the patient-controlled analgesia (PCA) device that was implanted during the postoperative
      period.

      Patients were divided into two groups using the envelope drawing method. Patients who
      received epidural morphine with PCIEA represented Group 1, epidural morphine with PCCEA
      represented Group 2. The anesthetist who collected data and the patients were blinded.

      All operations were performed by the same surgical team. The posterior instrumentation with
      pedicle screws was applied to thoracic and lumbar spine. Epidural catheter was inserted by
      surgeon under direct visualization at the midpoint of the incision and advanced 5-6 cm
      cephalad to thoracic 4-5 before surgical closure. Intubated patients was taken to in the
      reanimation intensive care unit after operation, IV acetaminophen 15 mg / kg was started
      before extubation and repeated every 6 hours.

      After extubation and a neurological examination, patients in the PCİEA group received
      morphine 50 µg/kg in 10 mL bolus, lockout time 1 hour, no infusion. In Group 2, PCECA
      infusion the following initial setting loading morphine 0.02mg/kg in 8mL, was maintained 0.01
      mg/kg continuous infusion 4mL, 0.05 mg/kg 2mL bolus dose. 30 minute lock-out interval. 4 hour
      limit was 4 mg/kg.

      Pain score, morphine usage, postoperative nausea and vomiting, pruritus, rate their
      satisfaction ,sedation scores and motor block were assessed by researchers who were blinded
      to the study groups at postoperatively 2., 4., 6., 8., 12., 18., ve 24.hour, in all patients.
    

Detailed description: 
      Scoliosis surgery is reported that the postoperative pain after scoliosis surgery that occurs
      due to Surgical trauma and severe reflex muscle spasm be severe and excruciating. There are
      many methods for postoperative pain management as opioid , paracetamol and non-steroidal
      anti-inflammatory drug with patient- controlled intravenous analgesia (IV-PCA). In addition;
      intrathecal opioids, one catheter epidural with intermittent dosing bolus of morphine or
      continuous infusion (either opioids or local anaesthetics or both), double epidural catheter
      with continuous infusion and intravenous ketamine infusion were preferred other postoperative
      pain management models.

      Epidural analgesia is accepted procedure with the efficacy and safety profile for
      postoperative pain management in major orthopedic surgery including scoliosis surgery.
      Epidural analgesia techniques commonly have been used in continuous infusion of local
      anesthetics with or without opioid. It was emphasized that there was not adequate data in the
      literature to provide argument concerning the use of epidural opioids after spinal surgery.
      The objective of this study was to compare the effects and side effects patient- controlled
      intermittent bolus epidural analgesia (PCIEA) and patient- controlled continuous epidural
      analgesia (PCCEA) with morphine for postoperative pain control in adolescent idiopathic
      scoliosis after posterior spinal fusion.

      Methods This prospective randomized controlled double-blinded study was conducted 47 patient
      between 8-18 years, American Society of Anesthesia Classification (ASA) I-II, with idiopathic
      scoliosis, scheduled for elective posterior spinal fusion.

      Patients with a history of allergy to the drugs used in the study protocol, drug abused ,
      preoperative neurologic deficit, inability to use a visual analogue scale, pulmonary, cardiac
      and neuropsychiatric disorders were excluded. Exclusion criteria during the study were
      accidental perforation of dura, faulty epidural catheter placement, postoperative neurologic
      deficit or uncontrollable nausea, vomiting and pruritus.

      Patients were divided into two groups using the envelope drawing method. Patients who
      received epidural morphine with PCIEA represented Group 1, epidural morphine with PCCEA
      represented Group 2. The anesthetist who collected data and the patients were blinded.

      All operations were performed by the same surgical team. The posterior instrumentation with
      pedicle screws was applied to thoracic and lumbar spine. Epidural catheter was inserted by
      surgeon under direct visualization at the midpoint of the incision and advanced 5-6 cm
      cephalad to thoracic 4-5 before surgical closure. Intubated patients was taken to in the
      reanimation intensive care unit after operation, IV acetaminophen 15 mg / kg was started
      before extubation and repeated every 6 hours.

      After extubation and a neurological examination, patients in the PCİEA group received
      morphine 50 µg/kg in 10 mL bolus, lockout time 1 hour, no infusion. In Group 2, PCECA
      infusion the following initial setting loading morphine 0.02mg/kg in 8mL, was maintained 0.01
      mg/kg continuous infusion 4mL, 0.05 mg/kg 2mL bolus dose. 30 minute lock-out interval. 4 hour
      limit was 4 mg/kg.

      Pain score, morphine usage, postoperative nausea and vomiting, pruritus, rate their
      satisfaction ,sedation scores and motor block were assessed by researchers who were blinded
      to the study groups at postoperatively 2., 4., 6., 8., 12., 18., ve 24.hour, in all patients.

      The data were given as median with min and max values Statistical analysis was performed
      using IBM SPSS statistics software 22.0. the groups were compared using Yates' corrected
      chi-square test and Mann-Whitney U test. Statistical significance was defined as P< 0.05
    

Intervention name(s): Intermittent bolus epidural morphine; continuous epidural morphine
Intervention type(s): Drug; Drug
Intervention description(s): morphine given with patient- controlled intermittent bolus epidural, 50 µg/kg in 10 mL bolus, lockout time 1 hour, no infusion; morphine given with patient- controlled continuous epidural, initial setting loading morphine 0.02mg/kg in 8mL, was maintained 0.01 mg/kg continuous infusion 4mL, 0.05 mg/kg 2mL bolus dose. 30 minute lock-out interval. 4 hour limit was 4 mg/kg.
Other intervention name(s): PCIEA; Group 1.; PCCEA; Group 2.
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia, Epidural,Pain, Postoperative