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

NCT03047044 | Completed DMC

• 1 other identifier: 4-2016-1079
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

lumbar fusion surgery; Patient Controlled Analgesia; Optimizing Basal Infusion Mode

Outcome Measures

Primary Outcomes (1)

• the pain numeric rating scale

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

  At postoperative 6 hours

Study Arms (2)

Conventional PCA mode

ACTIVE COMPARATOR

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

Other: Conventional PCA mode

Optimizing B.I (New) PCA mode

EXPERIMENTAL

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

Other: Optimizing basal infusion (B.I)

Interventions

Optimizing basal infusion (B.I) 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).

Optimizing B.I (New) PCA mode

Conventional PCA mode OTHER

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

Conventional PCA mode

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Back Pain; Spinal Stenosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 8, 2017
• Study Start: July 1, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)