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

NCT ID: NCT03047044

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-01-30

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.

Conditions

Back Pain; Fusion of Spine, Lumbar Region; Spinal Stenosis

Study Design

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

Study Groups

Conventional PCA mode

(Mode setting; total volume: 140 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 15 minutes)

Group Type: ACTIVE_COMPARATOR

Conventional PCA mode

Intervention Type: OTHER

Mode setting; total volume: 150 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 10 minutes

Optimizing B.I (New) PCA mode

(Mode setting; total volume: 140 ml, flow rate: changable by patients' requirement, bolus volume: 0.5 ml, and LOT: 15 minutes)

Group Type: EXPERIMENTAL

Optimizing basal infusion (B.I)

Intervention Type: OTHER

In the intervention group, the optimizing B.I PCA mode will be setted. This mode is setted that the amount of administered drug per hour will be increased by 0.3 ml by pressing bolus button (The interval: \~ 8 hr: 2 - 4 ml, 8-24 hr: 1 - 3 ml, 24 hours \~ : 0.5 - 2.5 ml). Conversely, if the bolus button is not used for 90 minutes, the administered amount of drug per hour is setted to be reduced by 0.1 ml, and the maximum (or minimum) allowable flow rate is 4 ml (or 0.5 ml).

Interventions

Optimizing basal infusion (B.I)

In the intervention group, the optimizing B.I PCA mode will be setted. This mode is setted that the amount of administered drug per hour will be increased by 0.3 ml by pressing bolus button (The interval: \~ 8 hr: 2 - 4 ml, 8-24 hr: 1 - 3 ml, 24 hours \~ : 0.5 - 2.5 ml). Conversely, if the bolus button is not used for 90 minutes, the administered amount of drug per hour is setted to be reduced by 0.1 ml, and the maximum (or minimum) allowable flow rate is 4 ml (or 0.5 ml).

Intervention Type: OTHER

Conventional PCA mode

Mode setting; total volume: 150 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 10 minutes

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

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

Other Identifiers

4-2016-1079

Identifier Type: -

Identifier Source: org_study_id