- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790007
COMPARISON OF INTRAOPERATIVE LOCAL ANESTHETIC APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS
March 19, 2021 updated by: ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital
COMPARISON OF INTRAOPERATIVE TRANSVERSUS ABDOMINIS PLANE BLOCK, LOCAL ANESTHESIA APPLICATION TO THE PORT SITES AND INTRAPERITONEAL LOCAL ANESTHETIC APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34734
- Fatih Sultan Mehmet Research and Training Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients over 18 years of age who were admitted to the general surgery department with the diagnosis of cholelithiasis
Exclusion Criteria:
- Patients who need to undergo peroperative open cholecystectomy procedure.
- Patients with local anesthetic or NSAID allergy
- Patients in pregnancy
- Patients who are breastfeeding
- Patients with connective tissue disease
- Patients with malignancy in postoperative gallbladder pathological examination and patients with any malignancy diagnosis
- Patients with renal impairment, where the effect of using Marcain is unknown
- Cardiac disease
- Patients with hepatic impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TROCHAR SITES LOCAL ANESTHETIC INJECTION
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 our study this local anesthetic agent will be applied for postoperative pain relief
Other Names:
|
No Intervention: CONTROL GROUP
group will be the control group and any of these methods will not be applied,
|
|
Active Comparator: Transversus Abdominis Plane Block
Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis muscle regions) will be applied.
|
In our study this local anesthetic agent will be applied for postoperative pain relief
Other Names:
|
Active Comparator: INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD
Intraperitoneal direct vision of the gallbladder excision 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 SF, 20 cc 0.5% bupivacaine solution total 40 cc spraying will be applied.
|
In our study this local anesthetic agent will be applied for postoperative pain relief
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of postoperative pain: visual analogue scale
Time Frame: 24 hours
|
the level of the pain will be assessed using the VAS ( visual analogue scale) which is a psychometric response scale and the patient has to indicate a position along a continuous line between two end-points (no pain and maximum pain) that best reflects the intensity of their pain.
The pain measurements will be done at 1,2,4,6,12,24 hours.
Test is easy to obtain, reliable, valid and can detect changes of over time
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
December 15, 2018
First Submitted That Met QC Criteria
December 27, 2018
First Posted (Actual)
December 31, 2018
Study Record Updates
Last Update Posted (Actual)
March 23, 2021
Last Update Submitted That Met QC Criteria
March 19, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANIL ERGIN....
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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