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

February 27, 2018 updated by: Mehmet Ali Erdoğan, Inonu University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey, 044100
        • Inonu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Postoperatively at 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Study Chair: Mahmut Durmuş, Profoser, Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Scoliosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Intermittent bolus epidural morphine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe