Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05676892 |
| Other study ID # |
Seoul_S11 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Seoul St. Mary's Hospital |
| Contact |
Tae ho Hong |
| Phone |
+82-10-5206-5266 |
| Email |
gshth[@]catholic.ac.kr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
1. Inclusion criteria
① Patients who underwent elective gallbladder surgery (cholelithiasis, chronic
cholecystitis, gallbladder polyps, gallbladder adenomyomatosis)
② 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
2. 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
④ Those who undergo surgery at the same time due to other organ diseases
⑤ Those with immunosuppression and hemorrhagic tendencies
⑥ Persons who have undergone preoperative percutaneous cholecystectomy
(PTGBD)
⑦ 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
3. Target number of subjects and calculation basis In order to calculate the number of
subjects in this study, it was assumed that the baseline postoperative pain score was
the same in both groups based on the existing literature, and the VAS score within 6
hours after surgery was 2.33 ± 0.99 in the ibuprofen group and 3.20 ± 1.83 in the
placebo group. seemed As a result of calculating the study subjects with 95% power using
two-group T-test with two-side with a two-sided significance level of 0.05, each group
requires 63 subjects, and calculating a 10% dropout rate, 70 subjects per group, a total
of 140 subjects subject is required
Study design
1. Design of clinical trials This clinical trial is an exploratory clinical trial to
evaluate whether intravenous analgesic use after surgery can help reduce postoperative
pain scores in gallbladder disease requiring elective surgery. implement On the day of
surgery, after determining whether the selection/exclusion criteria are met, suitable
subjects are randomly assigned to the test group and control group in a 1:1 ratio. Only
for the test group, an investigational drug (ibuprofen 800mg/8ml) is administered
through intravenous injection after surgery, and physiological saline is administered
for 30 minutes to the control group. Painkillers and physiological saline are
administered repeatedly at 12-hour intervals from the first dose until the patient is
discharged.
On the day of surgery (OP day) and the day of discharge, an adverse reaction
investigation, laboratory test, and physical examination are conducted to evaluate
safety and efficacy, and the degree of postoperative pain and hospitalization period are
evaluated. At 1 week after discharge, an outpatient visit is conducted for adverse
events, laboratory tests, and physical examinations to evaluate the degree of
postoperative pain, postoperative infection-related complications, complications other
than infection, and whether additional procedures are required. In addition, when
visiting the emergency room due to postoperative infection-related complications within
one month after discharge, the degree of postoperative pain, rehospitalization,
complications other than infection, and whether additional procedures are required are
evaluated and compared.
2. Method of subject registration and randomization Subjects who have listened to the
explanation of this clinical trial and agreed to voluntarily participate in the trial
will be given a subject identification code in the order in which they signed the
consent form at the screening visit. Randomization is performed to ensure the scientific
validity of clinical trials by ensuring that the subjectivity of the investigator is not
involved in the assignment.
Block randomization is performed to divide the patients into 2 groups and allocate them in a
1:1 ratio for patients who satisfy the selection/exclusion criteria and agree to participate
in the clinical trial. For randomization, a statistician independent of this clinical trial
generates a randomization number using SAS ver.9.4 for Microsoft Windows (SAS Institute Inc,
NC, Cary, USA) or higher and assigns them sequentially.
Method of operation
1. Surgery was started under general anesthesia
2. A trocar of 10 mm was placed on the navel, 5 mm under the blade, and 5 mm trocar was
placed on the right upper abdomen.
3. Pneumoperitoneum was performed using CO2 gas in the abdominal cavity.
- Double pressure through CO2 gas was maintained at 12mmHg / and 2L / min.
4. Dissection started from Calot's triangle, and the operation was performed by retrograde
cholecystectomy.
- The cystic duct was ligated with a 10mm clip, and the cystic artery was also
ligated with a 10mm clip.
- If the cystic duct was unstably ligated, ligation was performed through an end
loop.
- After ligation, the gallbladder was dissected from the liver.
5. Washed the surgical site.
6. The excised gallbladder was placed in a laparoscopic pocket and extracted through the
umbilicus.
7. The trocar was removed, the skin was sutured, and the operation was completed.
characteristics of observational and clinical test
- Hematology tests: Hematocrit, Hemoglobin, Platelet, WBC & Differential count
- Blood coagulation test: PT INR, aPTT, BT
- Blood chemistry test: SGOT (AST), SGPT (ALT), alkaline phosphatase, γ-GTP, bilirubin
(total / direct), fasting plasma glucose, BUN, creatinine, sodium, potassium, chloride,
total protein, albumin, uric acid, CPK, LDH, CRP
- Imaging medical examination
- Postoperative hospital stay
- Check for infection.
- Check for leakage of bile.
- Surgery time and bleeding amount were described.
- Postoperative complications
Statistical analysis In the case of categorical variables for the length of stay, surgical
time, and complication data obtained as secondary endpoints, n (%) was presented, and the
ratio difference between the two groups was tested using Chi-square or Fisher's exact test.
In addition, for continuous variables, the mean, standard deviation, median, minimum, and
maximum values were presented. The normality test was performed to test with Student's t-test
for normal distribution and the non-normal distribution Wilcoxon rank-sum test. The
difference between the two groups would be tested. All statistical analyses would use SPSS
version 21.0, and it would be judged that it was statistically significant below the
significance level of 0.05.
