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Completed

NCT Number: NCT03589404

Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation

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

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Key information

Conditions

Laparoscopy Abdominal Wall

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rso2

Device

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

Primary outcomes

  1. rso2

    Time frame: perioperative

    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

Secondary outcomes

  1. Visual Analog Scale

    Time frame: Postoperative 24 hours

    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)

  2. analgesic use

    Time frame: Postoperative 24 hours

    analgesic use

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 17, 2018
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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