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

Clinical trial to compare efficacy and safety of 'PF-72', a sustained-release drug delivery system that is injected into the incision site during surgical operation after mixing with 0.75% ropivacine for the purpose of reducing postoperative pain, with 0.75% ropivacine in patients undergoing laparoscopic gastrectomy or laparoscopic colorectal surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004388

Enrollment

108

Registered

2019-10-28

Start date

2019-11-11

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

None listed

Interventions

Procedure/Surgery : At the time when the main procedure of the surgery is finished and the skin is to be sutured, a procedure is performed to alleviate the postoperative pain. For the test group (PF-7

ropivacaine), 0.8 ml of 0.75&#37

ropivacaine per 1 cm of incision site is injected at the same site as the test group.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The area under the curve of patin intensity on major incision site unil 72 hr postoperatively	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Moon Choi

Asan Medical Center

rios76@hanmail.net+82-2-3010-1704

Outcome results