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

NCT03011359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-02-28

No results posted yet for this study

Summary

Colon resection is one of the major surgery, the postoperative pain is so severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The most common pain management of this surgery is the intravenous (IV) PCA. If it is relatively insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce the pain effectively. Consequently, it may result in the a lot of rescue analgesics use, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. And the patient's satisfaction to the PCA may be low.

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

Interventions

OTHER

Optimizing B.I (New) PCA mode

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: \~ 6 hr: 1.5 - 3.5 ml, 6-24 hr: 1 - 3 ml, 24 hr \~ : 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 3.5 ml (or 0.5 ml).

OTHER

Conventional PCA mode

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-17
Primary Completion
2018-12-07
Completion
2018-12-07

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03011359 on ClinicalTrials.gov