LaparoscopyNCT03652506
The Impact of Anterior Abdominal Wall Tissue Oxygenation During Pneumoperitoneum of Regional Anesthesia Methods
A study testing regional oxymetry probe, Quadratus Lumborum block and Thoracic Epidural block in people with Laparoscopy and Abdominal Wall, run by Bursa Yuksek Ihtisas Training and Research Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparoscopy, Abdominal Wall, Regional Anesthesia
- What is being tested?
- regional oxymetry probe, Quadratus Lumborum block and Thoracic Epidural block
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2018to 28 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent laparoscopic cholecystectomy
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation the Effect of Regional Anesthesia Methods Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy
During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall.
Read the 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.
- Conditions
- Laparoscopy, Abdominal Wall, Regional Anesthesia
- Being tested
- regional oxymetry probe, Quadratus Lumborum block, Thoracic Epidural block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional oxymetry probeDevice
Also called abdominal wall tissue oxygenation
The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
Quadratus Lumborum blockProcedure or surgery
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 blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins. Receives: Device: regional oxymetry probe |
| Group E | Active comparator | 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. Receives: Device: regional oxymetry probe; Procedure: Thoracic Epidural block |
| Group Q | Active comparator | 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. Receives: Device: regional oxymetry probe; Procedure: Quadratus Lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
rso2
The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line
Measured: peroperative 2 hours
Secondary outcomes (3)
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)
Measured: Postoperative 24 hours
tramadol consumption
tramadol consumption with PCA (patient-controlled analgesia ) device
Measured: Postoperative 24 hours
additional analgesic use
additional analgesic use (paracetamol and NSAİD)
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start28 Aug 2018 (estimated)
- Primary completion28 Dec 2018 (estimated)
- Study completion28 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective,randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, M.D, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652506
- Sponsor's protocol ID
- 2011-KAEK-25 2018/06-27
- Status last verified
- Aug 2018
- First submitted
- 19 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation the Effect of Regional Anesthesia Methods Anterior Abdominal Wall Tissue Oxygenation on Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03652506
- Acronym / sponsor ID
- 2011-KAEK-25 2018/06-27
- Conditions
- Laparoscopy, Abdominal Wall, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 28 Aug 2018 (estimated)
- Primary completion
- 28 Dec 2018 (estimated)
- Study completion
- 28 Dec 2018 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- prospective,randomized
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: regional oxymetry probeThe 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 comparator | Device: regional oxymetry probe, Procedure: Thoracic Epidural blockThoracic 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 comparator | Device: regional oxymetry probe, Procedure: Quadratus Lumborum blockUltrasound 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent laparoscopic cholecystectomy
Key exclusion criteria (8 listed)
- Previous surgeon surgeon
- Local anesthetic allergy,
- Bleeding is a diathesis disorder
- Mental impairment,
- Allergic to the drugs used,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regional oxymetry probeAlso: abdominal wall tissue oxygenationThe regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins. | Device | Group A, Group E, Group Q |
| Quadratus Lumborum blockUltrasound 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. | Procedure or surgery | Group Q |
| Thoracic Epidural blockThoracic 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. | Procedure or surgery | Group E |
Primary outcome
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
3 secondary outcomes
Visual Analog Scale
Time frame: Postoperative 24 hours
tramadol consumption
Time frame: Postoperative 24 hours
additional analgesic use
Time frame: Postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Korgün Ökmen, M.D principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing regional oxymetry probe, Quadratus Lumborum block and Thoracic Epidural block in people with Laparoscopy and Abdominal Wall, run by Bursa Yuksek Ihtisas Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact korgün Ökmen, M.D (05057081021, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rso2 (time frame: peroperative 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.