Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03790007 |
| Other study ID # |
ANIL ERGIN.... |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2018 |
| Est. completion date |
March 1, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Fatih Sultan Mehmet Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Since 1987, laparoscopic cholecystectomy has become the standard procedure for gallbladder
stones and lesions. Complications due to improvements in laparoscopy and increased surgical
experience have decreased day by day, but there is still a problem in terms of postoperative
pain management. Several pain management procedures have been tried to combat pain after
laparoscopic cholecystectomy. The aim of this study is to decrease the length of hospital
stay, to increase the comfort of the patient and to reduce the cost of treatment. Local
anesthetic injection to port locations, intraperitoneal periportal local anesthetic injection
,Transversus Abdominis Plane Blok and without any local anesthetic application to the control
group compared to the group's analgesic efficiency and to reduce the amount of analgesics
needed, shorten the length of hospital stay and improve patient comfort.
Description:
Laparoscopic cholecystectomy procedure will be performed in patients older than 18 years of
age for the diagnosis of cholelithiasis. Laparoscopic cholecystectomy procedure will be
performed.4 patients group will be formed Power: 0.80 and alpha: :0.05 The minimum number of
samples determined for each group is n: 34 for each group. It will be determined. In our
clinic, local anesthetic injections are performed routinely to the trocar areas in
laparoscopic cholecystectomy operations. After endotracheal intubation at the beginning of
the operation, after appropriate skin staining and sterile dressing, Transversus abdominis
plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis
muscle regions) will be applied. to the second group local anesthetic injection (6 cc to
subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution)
to be applied, in the third group intraperitoneal direct vision of the gallbladder
area-periportal area under the direct injection of local anesthetic spraying process
(percutaneous method injected into the periportal area 1: 1 diluted with 20 cc saline, 20 cc
0.5% bupivacaine solution total 40 cc spraying will be applied. The fourth group will be the
control group and any of these methods will not be applied, the operation time and
peroperative complications (pouch perforation etc.) will be recorded. Paracetamol 1 g + 1 mg
/ kg tramadol IV will be applied to all four groups as standard before extubation. Visual
analogue scale (VAS) will be applied to all patients in the postoperative period. If VAS> 3
is still present, a dose of 1 mg / kg tramadol will be administered. Tenoxicam 1x1 IV will be
applied to the patients on the 12th hour. All patients were postoperative; 1,2,4,6,12,24. VAS
scores , patient satisfaction (0: never satisfied, 5: very satisfied) will be recorded. The
group of patients will be determined according to the order of surgery. Pain scores of the
patients will be performed by a physician who is not in the operation who does not know which
group is taken. The patients included in the group will not be known to the patient by the
pain scoring system and the study will be done as double blind. Patients will be randomized
with this method.
