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

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03652506
• Other study ID #: 2011-KAEK-25 2018/06-27
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: December 28, 2018

Study information

• Verified date: August 2018
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: korgün Ökmen, M.D
• Phone: 05057081021
• Email: korgunokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 28, 2018
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Wall
• Laparoscopy
• Regional Anesthesia

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rso2	The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line	peroperative 2 hours
Secondary	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
Secondary	tramadol consumption	tramadol consumption with PCA (patient-controlled analgesia ) device	Postoperative 24 hours
Secondary	additional analgesic use	additional analgesic use (paracetamol and NSAID)	Postoperative 24 hours