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Completed

NCT Number: NCT03011359

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

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subjects who undergoing colon resection due to colon cancer
  • ASA class Ⅰ-Ⅲ
  • Written consents obtained to participate voluntarily in this clinical trial

Exclusion criteria

  • 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

Treatment and study plan

Optimizing B.I (New) PCA mode

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: ~ 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 names: (Mode setting; total volume: 150 ml, flow rate: changable by patients' requirement, bolus volume: 0.5 ml, and LOT: 10 minutes)

Conventional PCA mode

Other

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

Primary outcomes

  1. pain

    Time frame: At postoperative 6 hours

    At 6 hours after surgery, the pain scores will be measured by numeric rating scale range from 0 to 10.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

The Comparison of Postoperative Pain After Colon Resection in Intravenous

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2017
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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