The Impact of Anterior Abdominal Wall Tissue Oxygenation During Pneumoperitoneum of Regional Anesthesia Methods

Investigation the Effect of Regional Anesthesia Methods Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy

During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall.

Study Overview

• Status: Unknown
• Conditions: Laparoscopy; Regional Anesthesia; Abdominal Wall
• Intervention / Treatment: Device: regional oxymetry probe; Procedure: Thoracic Epidural block; Procedure: Quadratus Lumborum block

Detailed Description

The investigators aimed to investigate the effects of regional anesthesia methods administered during laparoscopic cholecystectomy on abdominal wall oxygenation and postoperative pain scores.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: korgün Ökmen, M.D; Phone Number: 05057081021; Email: korgunokmen@gmail.com
• Study Contact Backup: Name: Burcu Metin Ökmen, M.D; Phone Number: 05057081020; Email: burcumetinokmen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who were in the American Society of Anesthesiologists (ASA) I-III class
• Underwent laparoscopic cholecystectomy

Exclusion Criteria:

• Previous surgeon surgeon
• Local anesthetic allergy,
• Bleeding is a diathesis disorder
• Mental impairment,
• Allergic to the drugs used,
• Patients who are not reluctant to participate in the study,
• Presence of infection in the block area,
• Patients whose body mass index is over 30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.	Device: regional oxymetry probe; The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.; Other Names: abdominal wall tissue oxygenation
Active Comparator: Group E; Thoracic Epidural block +The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.	Device: regional oxymetry probe; The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.; Other Names: abdominal wall tissue oxygenation; Procedure: Thoracic Epidural block; Thoracic Epidural block with 20 ml %0.25 bupivacaine+The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
Active Comparator: Group Q; Ultrasound guided unilateral anterior Quadratus Lumborum block +The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.	Device: regional oxymetry probe; The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.; Other Names: abdominal wall tissue oxygenation; Procedure: Quadratus Lumborum block; Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 bupivacaine+The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rso2	The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line	peroperative 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)	Postoperative 24 hours
tramadol consumption	tramadol consumption with PCA (patient-controlled analgesia ) device	Postoperative 24 hours
additional analgesic use	additional analgesic use (paracetamol and NSAİD)	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Korgün Ökmen, M.D, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 28, 2018
• Primary Completion (Anticipated): December 28, 2018
• Study Completion (Anticipated): December 28, 2018

Study Registration Dates

• First Submitted: August 19, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2011-KAEK-25 2018/06-27

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