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

NCT ID: NCT02813018

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-07
• Study Completion Date: 2017-07-15

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.

Conditions

Pediatric Surgical Patients; Preemptive Epidural Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

preemptive group

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

Group Type: EXPERIMENTAL

0.2 ml/kg of 0.2% ropivacaine

Intervention Type: PROCEDURE

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.

saline group

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

Group Type: PLACEBO_COMPARATOR

0.2mg/kg of Normal Saline

Intervention Type: PROCEDURE

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.

Interventions

0.2 ml/kg of 0.2% ropivacaine

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

0.2mg/kg of Normal Saline

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 15710025 (View on PubMed)

Other Identifiers

4-2016-0322

Identifier Type: -

Identifier Source: org_study_id