COMPARISON OF INTRAOPERATIVE LOCAL ANESTHETIC APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS

Sponsor

Fatih Sultan Mehmet Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03790007

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Bupivacaine	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

3 types of local anesthetic applying method will be compared3 types of local anesthetic applying method will be compared

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Bupivacaine In our study this local anesthetic agent will be applied for postoperative pain relief Other Names: marcaine
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)	Drug: Bupivacaine In our study this local anesthetic agent will be applied for postoperative pain relief Other Names: marcaine
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.	Drug: Bupivacaine In our study this local anesthetic agent will be applied for postoperative pain relief Other Names: marcaine
No Intervention: CONTROL GROUP group will be the control group and any of these methods will not be applied,

Outcome Measures

Primary Outcome Measures

Level of postoperative pain: visual analogue scale [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fatih Sultan Mehmet Research and Training Hospital	Istanbul		Turkey	34734

Sponsors and Collaborators

Fatih Sultan Mehmet Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ANIL ERGIN, asistant doctor, Fatih Sultan Mehmet Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT03790007

Other Study ID Numbers:

ANIL ERGIN....

First Posted:

Dec 31, 2018

Last Update Posted:

Mar 23, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ANIL ERGIN, asistant doctor, Fatih Sultan Mehmet Training and Research Hospital

laparoscopic cholecystectomy

postoperative pain relief

local anesthetic

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Mar 23, 2021