Study on efficacy and safety of the slow release drug delivery device PF-72

Not Applicable

Conditions: Diseases of the digestive system

Registration Number: KCT0004388

Lead Sponsor: TGelBio Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 108

Inclusion Criteria

1. Adults aged 19 to 70
2. American society of anesthesiologist physical status 1, 2 or 3
3. Patients with elective surgery scheduled for laparoscopic gastrectomy for gastric cancer or for laparoscopic colon resection for colon cancer
4. Patients without clinically significant abnormal findings in laboratory tests
5. Patients who decided to voluntarily participate in the trial and who agreed in writing to the consent of the study ethics review committee

Exclusion Criteria

1. Patients scheduled for laparotomy
2. Patients requiring emergency surgery
3. Patients with a history of intra-abdominal organs resection
4. Patients with pain greater than zero at the site of surgery on the abdomen, evaluated on the preoperative 100 mm visual analog scale (VAS)
5. Patients scheduled for resection of the organs other than the stomach or colon
6. Patients with cognitive impairment that do not complain of subjective pain
7. Patients who weighed less than 50 ? for men and less than 45 ? for women
8 Body mass index more than 35 kg/m2
9. septic patients
10. Women who were pregnant or lactating
11. Clinically significant impairment of cardiovascular, hepatic, or renal function; history of cardiac arrhythmia
12. Use of pre-operative analgesic or neuroleptic medication
13. History of substance abuse or psychiatric disease

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The area under the curve of patin intensity on major incision site unil 72 hr postoperatively

Secondary Outcome Measures

Name	Time	Method
Postoperative pain measeud by NRS (numerical rating scale) at 3, 6, 24, 48, and 72 hours postoperatively;Total cumulative amount of PCA and frequency and dosage of rescue analgesics