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

Not Applicable

Completed

• Conditions: Fusion of Spine, Lumbar Region; Back Pain; Spinal Stenosis
• Interventions: Other: Conventional PCA mode; Other: Optimizing basal infusion (B.I)

• Registration Number: NCT03047044
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-05
• Study First Submitted QC: 2017-02-05
• Study First Posted: 2017-02-08
• Study Start: 2018-07-01
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

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

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Exclusion Criteria

1. Sudden change of surgical plan
2. Patients who have the hypersensitivity to the pain killers including narcotics
3. Patients who are unable to express the degree of pain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional PCA mode	Conventional PCA mode	(Mode setting; total volume: 140 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 15 minutes)
Optimizing B.I (New) PCA mode	Optimizing basal infusion (B.I)	(Mode setting; total volume: 140 ml, flow rate: changable by patients' requirement, bolus volume: 0.5 ml, and LOT: 15 minutes)

Primary Outcome Measures

Name	Time	Method
the pain numeric rating scale	At postoperative 6 hours	the pain scores will be measured by numeric rating scale range from 0 to 10.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of