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
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2018
CompletedStudy Start
First participant enrolled
August 28, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2018
CompletedAugust 29, 2018
August 1, 2018
4 months
August 19, 2018
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
rso2
The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line
peroperative 2 hours
Secondary Outcomes (3)
Visual Analog Scale
Postoperative 24 hours
tramadol consumption
Postoperative 24 hours
additional analgesic use
Postoperative 24 hours
Study Arms (3)
Group A
ACTIVE COMPARATORThe regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
Group E
ACTIVE COMPARATORThoracic 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.
Group Q
ACTIVE COMPARATORUltrasound 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.
Interventions
The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
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 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.
Eligibility Criteria
You may qualify if:
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent laparoscopic cholecystectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Korgün Ökmen, M.D
Bursa Yuksek Ihtisas Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participant, Outcomes Assessor
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 19, 2018
First Posted
August 29, 2018
Study Start
August 28, 2018
Primary Completion
December 28, 2018
Study Completion
December 28, 2018
Last Updated
August 29, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share