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The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery

Primary Purpose

Pediatric Surgical Patients, Preemptive Epidural Analgesia

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

0.2 ml/kg of 0.2% ropivacaine

0.2mg/kg of Normal Saline

About this trial

This is an interventional other trial for Pediatric Surgical Patients focused on measuring child, analgesia, epidural, pain, postoperative, orthopedics

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pediatric patients (3-12 years of age) scheduled for corrective osteotomy of the lower extremities
ASA class I and II

Exclusion Criteria:

Coagulopathy
Neurological disease
Allergy to local anesthetics or contraindication to use of ropivacaine
Infection at the site of epidural catheter insertion

Sites / Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

preemptive group

saline group

Arm Description

Group who will be received ropivacaine bolus and continous infusion 5 minutes before skin incision.

Group who will be received saline bolus and continous infusion 5 minutes before skin incision

Outcomes

Primary Outcome Measures

FLACC scale score (Face, Legs, Activity, Cry, Consolability)

Secondary Outcome Measures

Full Information

NCT ID

NCT02813018

First Posted

June 22, 2016

Last Updated

June 19, 2018

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02813018

Brief Title

The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

July 7, 2016 (Actual)

Primary Completion Date

July 15, 2017 (Actual)

Study Completion Date

July 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Management of postoperative pain is critical in the pediatric patients, however, safe and effective analgesia for pediatric surgical patients remains a challenge. Preemptive analgesia is based on preventing a prolonged change in central nervous system function by blocking afferent input before the surgical stimulation may evoke central sensitization and aggravate amplification and prolongation of postoperative pain. However, the clinical efficacy of preemptive analgesia is still controversial. In this study, the investigators aim to assess the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for corrective osteotomy of the lower extremities expecting severe postoperative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric Surgical Patients, Preemptive Epidural Analgesia

Keywords

child, analgesia, epidural, pain, postoperative, orthopedics

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

preemptive group

Arm Type

Experimental

Arm Description

Group who will be received ropivacaine bolus and continous infusion 5 minutes before skin incision.

Arm Title

saline group

Arm Type

Placebo Comparator

Arm Description

Group who will be received saline bolus and continous infusion 5 minutes before skin incision

Intervention Type

Procedure

Intervention Name(s)

0.2 ml/kg of 0.2% ropivacaine

Intervention Description

In the preemptive group, 5 minutes before skin incision, the epidural catheter is dosed with 0.2 ml/kg of 0.2% ropivacaine, followed by continuous infusion of 5 minutes before skin incision at 0.2 ml/kg/h.

Intervention Type

Procedure

Intervention Name(s)

0.2mg/kg of Normal Saline

Intervention Description

In the saline group, 5 minutes before skin incision, the epidural catheter is dosed with 0.2 ml/kg of normal saline, followed by continuous infusion of 5 minutes before skin incision at 0.2 ml/kg/h.

Primary Outcome Measure Information:

Title

FLACC scale score (Face, Legs, Activity, Cry, Consolability)

Time Frame

0-6 hours after the operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pediatric patients (3-12 years of age) scheduled for corrective osteotomy of the lower extremities ASA class I and II Exclusion Criteria: Coagulopathy Neurological disease Allergy to local anesthetics or contraindication to use of ropivacaine Infection at the site of epidural catheter insertion

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

15710025

Citation

Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.

Results Reference

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The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery

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