Effects of Intravenous Ibuprofen on Acute Pain After Laparoscopic Cholecystectomy; a Double-blind, Randomized, Placebo-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Seoul St. Mary's Hospital
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- VAS (Visual Analogue Scale) score
Study Overview
Brief Summary
This clinical trial is a medical intervention study to evaluate the necessity and effectiveness of intravenous ibupropan for postoperative acute pain relief after laparoscopic cholecystectomy in benign gallbladder disease. Comparison and evaluation of changes in pain scores after surgery according to the presence or absence of use.
Detailed Description
Cholecystectomy is the most common abdominal surgical procedure and is usually performed laparoscopically. Laparoscopic cholecystectomy is considered the standard surgery for gallstone disease, and this procedure has the advantages of less postoperative pain, better cosmetic results, shorter hospital stay, and faster wound healing than open cholecystectomy.
There are several factors that can cause pain after laparoscopic cholecystectomy, including stimulation of the phrenic nerve due to CO2 injection into the abdominal cavity, incision pain at the port site, and pain at the gallbladder removal site. Postoperative pain is an acute sensation that accompanies the surgical trauma and the observed inflammatory process and decreases as the tissue heals.
Postoperative analgesics are known to prevent pain-related effects in patients after surgery, such as increased cardiovascular system workload and increased stress response due to neuroendocrine and sympathetic nervous system activation. Like other NSAIDs, ibupropan is a propionic acid derivative that has anti-inflammatory, antipyretic and analgesic effects. The oral form has been used safely for a long time and is one of the most commonly used NSAIDs. Ibuprofan in the intravenous (IV) form has been used in the United States since 2009 for the treatment of mild to moderate and severe pain in combination with narcotic analgesics. Research on ibuprolan for intravenous injection is still insufficient, and there are very few studies showing its effect on pain relief after surgery. Therefore, this study was conducted in a double-blind, prospective, randomized, placebo-controlled clinical trial to investigate the evidence for clinical usefulness of the effect of intravenous ibupropan on postoperative pain in patients who underwent laparoscopic cholecystectomy.
Study population
- Inclusion criteria
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who underwent elective gallbladder surgery (cholelithiasis, chronic cholecystitis, gallbladder polyps, gallbladder adenomyomatosis)
- •Patients between the ages of 19 and 65 ③ A person who voluntarily signed a written consent form after hearing and understanding the explanation of this clinical trial
Exclusion Criteria
- •Patients with acute cholecystitis
- •② Gallbladder cancer
- •Cholecystitis with a gallbladder thickness of 4 mm or more on CT or ultrasound
- •Cholecystitis with adhesions with surrounding organs due to inflammation of the gallbladder
- •Pregnant or lactating women
- •Those who undergo surgery at the same time due to other organ diseases ⑤ Those with immunosuppression and hemorrhagic tendencies
- •Persons who have undergone preoperative percutaneous cholecystectomy (PTGBD)
- •Persons who need drainage tube installation during surgery ⑧ Those who participated in other clinical trials within 3 months before screening ⑨ Persons judged by other investigators to be inappropriate to participate in this clinical trial
Outcomes
Primary Outcomes
VAS (Visual Analogue Scale) score
Time Frame: 7 days
Postoperative pain score in patients who underwent a laparoscopic cholecystectomy with the ibuprofen and normal saline. pain score : minimum 0 to maximum 10 (0:no pain - 10: worst pain)
Secondary Outcomes
- consumption of analgesics(Participants will be followed for the duration of hospital stay, an expected average of 2 days)
Investigators
Taeho Hong
Professor
Seoul St. Mary's Hospital