Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation

Laparoscopy Clinical Trial

Official title:

Investigation of the Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589404
• Other study ID #: 2011-KAEK-25 2018/04-24
• Status: Completed
• Phase: N/A
• Start date: July 15, 2018
• Est. completion date: November 15, 2019

Study information

• Verified date: December 2019
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• 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 pneumoperitoneum administered during laparoscopic cholecystectomy on abdominal wall oxygenation and postoperative pain scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 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
• Pneumoperitoneum

Intervention

Device:
• rso2
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
Turkey	Bursa Yuksek Ihtisas Training and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rso2	The regional oxymetry probe (Medtronic Quick Assist INVOS™ (In-Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter) will be placed in the abdominal region of the umbilicus in the middle clavicular line	perioperative
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	analgesic use	analgesic use	Postoperative 24 hours