NCT03047044

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

Completed NA Last updated 28 February 2019

What this trial tests

NA trial testing Optimizing basal infusion (B.I) in Back Pain in 58 participants. Completed in 30 January 2019.

Timeline

1 July 2018

Primary endpoint
30 January 2019

30 January 2019

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	58
Start date	1 July 2018
Primary completion	30 January 2019
Estimated completion	30 January 2019
Sites	1 location across South Korea

Drugs / interventions tested

• Optimizing basal infusion (B.I)
• Conventional PCA mode

Conditions studied

• Back Pain — all drugs for Back Pain →
• Fusion of Spine, Lumbar Region — all drugs for Fusion of Spine, Lumbar Region →
• Spinal Stenosis — all drugs for Spinal Stenosis →

Sponsor

Yonsei University

Who can join

Adults 20 to 70, any sex, with Back Pain or Fusion of Spine, Lumbar Region. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.