Effects of Intravenous Ibuprofen on Acute Pain After Laparoscopic Cholecystectomy
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2022
CompletedFirst Posted
Study publicly available on registry
January 9, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 3, 2023
February 1, 2023
4 months
December 28, 2022
February 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS (Visual Analogue Scale) score
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)
7 days
Secondary Outcomes (1)
consumption of analgesics
Participants will be followed for the duration of hospital stay, an expected average of 2 days
Study Arms (2)
The experimental group in benign gallbladder disease
EXPERIMENTALinclusion criteria * 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 intravenous ibuprofen 800mg/8ml was used after surgery.
The controled group in benign gallbladder disease
EXPERIMENTALinclusion criteria * 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 normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) was used after surgery.
Interventions
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 a 5 mm trocar was placed on the right upper abdomen. 3. Pneumoperitoneum was performed using CO2 gas in the abdominal cavity. 4. Dissection started from Calot's triangle, and the operation was performed by retrograde cholecystectomy. 5. The excised gallbladder was placed in a laparoscopic pocket and extracted through the umbilicus. 6. The trocar was removed, and the skin was sutured
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of HBP Surgery, Seoul St. Mary's hospital
Seoul, Seocho-gu, Banopo-dong, 137-701, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sung eun Park
The Catholic University of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 28, 2022
First Posted
January 9, 2023
Study Start
March 1, 2023
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
February 3, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share