Skip to main content
Clinical Trials/NCT03047044
NCT03047044
Completed
N/A

The Comparison of Postoperative Pain After Lumbar Fusion Surgery in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment

Yonsei University1 site in 1 country58 target enrollmentJuly 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Back Pain
Sponsor
Yonsei University
Enrollment
58
Locations
1
Primary Endpoint
the pain numeric rating scale
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The postoperative pain of lumbar fusion surgery is very severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The most common pain control method of this surgery is the intravenous (IV) PCA. but, if it is relatively insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce the pain intensity effectively. Consequently, it may result in the a lot of rescue analgesics requirement, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. In addition, the patient's satisfaction to the PCA may be low compared with that of expected. For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a new mode, so that the administered rate and amount of drug can be increased or decreased according to the patient's use of bolus button. Therefore, this PCA device can be implemented to the conventional mode, and added the function of automatically controlling the basal rate and administered amount of drug according to the use demand of the patient. However, since there are few studies related to this new mode of PCA, more research is needed in patients with postoperative pain.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
January 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The subjects who undergoing lumbar fusion surgery
  • ASA class Ⅰ-Ⅲ
  • Written consents obtained to participate voluntarily in this clinical trial

Exclusion Criteria

  • Sudden change of surgical plan
  • Patients who have the hypersensitivity to the pain killers including narcotics
  • Patients who are unable to express the degree of pain

Outcomes

Primary Outcomes

the pain numeric rating scale

Time Frame: At postoperative 6 hours

the pain scores will be measured by numeric rating scale range from 0 to 10.

Study Sites (1)

Loading locations...

Similar Trials