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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

The Comparison of Postoperative Pain After Colon Resection in Intravenous

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03011359
Enrollment
66
Registered
2017-01-05
Start date
2018-06-17
Completion date
2018-12-07
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

Colon resection, Patient Controlled Analgesia, Optimizing Basal Infusion Mode

Brief 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.

Interventions

OTHEROptimizing 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).

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

1. The subjects who undergoing colon resection due to colon cancer 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

Design outcomes

Primary

MeasureTime frameDescription
painAt postoperative 6 hoursAt 6 hours after surgery, the pain scores will be measured by numeric rating scale range from 0 to 10.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026