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

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ClinicalTrials.gov Identifier: NCT03652506
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Korgün Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Laparoscopy Abdominal Wall Regional Anesthesia Device: regional oxymetry probe Procedure: Quadratus Lumborum block Procedure: Thoracic Epidural block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective,randomized
Masking: Single (Participant)
Masking Description: Participant, Outcomes Assessor
Primary Purpose: Diagnostic
Official Title: Investigation the Effect of Regional Anesthesia Methods Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy
Estimated Study Start Date : August 28, 2018
Estimated Primary Completion Date : December 28, 2018
Estimated Study Completion Date : December 28, 2018

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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. rso2 [ Time Frame: peroperative 2 hours ]
    The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line


Secondary Outcome Measures :
  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. tramadol consumption [ Time Frame: Postoperative 24 hours ]
    tramadol consumption with PCA (patient-controlled analgesia ) device

  3. additional analgesic use [ Time Frame: Postoperative 24 hours ]
    additional analgesic use (paracetamol and NSAİD)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652506


Contacts
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Contact: korgün Ökmen, M.D 05057081021 korgunokmen@gmail.com
Contact: Burcu Metin Ökmen, M.D 05057081020 burcumetinokmen@gmail.com

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

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Responsible Party: Korgün Ökmen, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03652506     History of Changes
Other Study ID Numbers: 2011-KAEK-25 2018/06-27
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs