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

NCT03790007 | Completed Phase 4

• 1 other identifier: ANIL ERGIN....
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

laparoscopic cholecystectomy; postoperative pain relief; local anesthetic

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Study Arms (4)

Transversus Abdominis Plane Block

ACTIVE COMPARATOR

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

TROCHAR SITES LOCAL ANESTHETIC INJECTION

ACTIVE COMPARATOR

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

INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD

ACTIVE COMPARATOR

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

CONTROL GROUP

NO INTERVENTION

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

Interventions

Bupivacaine DRUG

In our study this local anesthetic agent will be applied for postoperative pain relief

Also known as: marcaine

INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD; TROCHAR SITES LOCAL ANESTHETIC INJECTION; Transversus Abdominis Plane Block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age who were admitted to the general surgery department with the diagnosis of cholelithiasis

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asistant doctor

Model Details: 3 types of local anesthetic applying method will be compared

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: December 31, 2018
• Study Start: November 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)