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

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Intermittent bolus epidural morphine
continuous epidural morphine
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Analgesia, Epidural,Pain, Postoperative

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Inonu university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intermittent bolus epidural morphine

Continuous epidural morphine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain Scores (at movement and at rest)
Pain scores were assessed using a visual analog scale (0: No pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10: Excruciating pain).

Secondary Outcome Measures

Full Information

First Posted
January 27, 2016
Last Updated
February 27, 2018
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT02669004
Brief Title
Intermittent Epidural Bolus Versus Epidural Infusion for Posterior Spinal Fusion After Adolescent Idiopathic Scoliosis
Official Title
Patient-controlled Intermittent Epidural Bolus Versus Epidural Infusion for Posterior Spinal Fusion After Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Analgesia, Epidural,Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermittent bolus epidural morphine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Continuous epidural morphine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intermittent bolus epidural morphine
Other Intervention Name(s)
PCIEA, Group 1.
Intervention Description
morphine given with patient- controlled intermittent bolus epidural, 50 µg/kg in 10 mL bolus, lockout time 1 hour, no infusion
Intervention Type
Drug
Intervention Name(s)
continuous epidural morphine
Other Intervention Name(s)
PCCEA, Group 2.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Scores (at movement and at rest)
Description
Pain scores were assessed using a visual analog scale (0: No pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10: Excruciating pain).
Time Frame
Postoperatively at 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmut Durmuş, Profoser
Organizational Affiliation
Inonu University
Official's Role
Study Chair
Facility Information:
Facility Name
Inonu university
City
Malatya
ZIP/Postal Code
044100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20091934
Citation
Taenzer AH, Clark C. Efficacy of postoperative epidural analgesia in adolescent scoliosis surgery: a meta-analysis. Paediatr Anaesth. 2010 Feb;20(2):135-43. doi: 10.1111/j.1460-9592.2009.03226.x.
Results Reference
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PubMed Identifier
18458547
Citation
Borgeat A, Blumenthal S. Postoperative pain management following scoliosis surgery. Curr Opin Anaesthesiol. 2008 Jun;21(3):313-6. doi: 10.1097/ACO.0b013e3282f82baa.
Results Reference
background
PubMed Identifier
19700988
Citation
Gauger VT, Voepel-Lewis TD, Burke CN, Kostrzewa AJ, Caird MS, Wagner DS, Farley FA. Epidural analgesia compared with intravenous analgesia after pediatric posterior spinal fusion. J Pediatr Orthop. 2009 Sep;29(6):588-93. doi: 10.1097/BPO.0b013e3181b2ba08.
Results Reference
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Intermittent Epidural Bolus Versus Epidural Infusion for Posterior Spinal Fusion After Adolescent Idiopathic Scoliosis

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