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Clinical Trials/NCT03011359
NCT03011359CompletedNot Applicable

The Comparison of Postoperative Pain After Colon Resection in Intravenous

Yonsei University1 site in 1 country66 target enrollmentStarted: June 17, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
66
Locations
1
Primary Endpoint
pain

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

1) Conventional PCA mode

Experimental

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

Intervention: Conventional PCA mode (Other)

2) Optimizing B.I PCA mode

Active Comparator

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

Intervention: Optimizing B.I (New) PCA mode (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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