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Intermittent Epidural Bolus Versus Epidural Infusion for Posterior Spinal Fusion After Adolescent Idiopathic Scoliosis

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ClinicalTrials.gov Identifier: NCT02669004
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mehmet Ali Erdoğan, Inonu University

Brief 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.


Condition or disease Intervention/treatment Phase
Pain Drug: Intermittent bolus epidural morphine Drug: continuous epidural morphine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient-controlled Intermittent Epidural Bolus Versus Epidural Infusion for Posterior Spinal Fusion After Adolescent Idiopathic Scoliosis
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Active Comparator: Intermittent bolus epidural morphine

Patients who received epidural morphine with patient- controlled intermittent bolus epidural analgesia (PCIEA) represented Group 1. 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.

Patients received morphine 50 µg/kg in 10 mL bolus, lockout time 1 hour, no infusion.

Drug: Intermittent bolus epidural morphine
morphine given with patient- controlled intermittent bolus epidural, 50 µg/kg in 10 mL bolus, lockout time 1 hour, no infusion
Other Names:
  • PCIEA
  • Group 1.

Active Comparator: Continuous epidural morphine
epidural morphine with patient- controlled continuous epidural analgesia (PCCEA) represented Group 2. 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.
Drug: continuous epidural morphine
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 Names:
  • PCCEA
  • Group 2.




Primary Outcome Measures :
  1. Pain Scores (at movement and at rest) [ Time Frame: Postoperatively at 24 hours ]
    Pain scores were assessed using a visual analog scale (0: No pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10: Excruciating pain).



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Clinical diagnosis of idiopathic scoliosis

  • scheduled for elective posterior spinal fusion
  • American Society of Anesthesia Classification (ASA) I-II

Exclusion Criteria:

  • 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:

  • accidental perforation of dura,
  • faulty epidural catheter placement, postoperative neurologic deficit
  • uncontrollable nausea, vomiting and pruritus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669004


Locations
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Turkey
Inonu university
Malatya, Turkey, 044100
Sponsors and Collaborators
Inonu University
Investigators
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Study Chair: Mahmut Durmuş, Profoser Inonu University

Publications:
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Responsible Party: Mehmet Ali Erdoğan, MD, Associate professor, Inonu University
ClinicalTrials.gov Identifier: NCT02669004     History of Changes
Other Study ID Numbers: scoliosis
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mehmet Ali Erdoğan, Inonu University:
Analgesia, Epidural,Pain, Postoperative
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents