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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring laparoscopic cholecystectomy, postoperative pain relief, local anesthetic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fatih Sultan Mehmet Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Transversus Abdominis Plane Block

TROCHAR SITES LOCAL ANESTHETIC INJECTION

INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD

CONTROL GROUP

Arm Description

Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis muscle regions) will be applied.

local anesthetic injection (6 cc to subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution to be applied)

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.

group will be the control group and any of these methods will not be applied,

Outcomes

Primary Outcome Measures

Level of postoperative pain: visual analogue scale
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

Secondary Outcome Measures

Full Information

First Posted
December 15, 2018
Last Updated
March 19, 2021
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03790007
Brief Title
COMPARISON OF INTRAOPERATIVE LOCAL ANESTHETIC APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
laparoscopic cholecystectomy, postoperative pain relief, local anesthetic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
3 types of local anesthetic applying method will be compared
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transversus Abdominis Plane Block
Arm Type
Active Comparator
Arm Description
Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis muscle regions) will be applied.
Arm Title
TROCHAR SITES LOCAL ANESTHETIC INJECTION
Arm Type
Active Comparator
Arm Description
local anesthetic injection (6 cc to subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution to be applied)
Arm Title
INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
group will be the control group and any of these methods will not be applied,
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
marcaine
Intervention Description
In our study this local anesthetic agent will be applied for postoperative pain relief
Primary Outcome Measure Information:
Title
Level of postoperative pain: visual analogue scale
Description
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
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fatih Sultan Mehmet Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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