Postoperative PainNCT03751540
Retrospective Evaluation of Plane Blocks in Laparoscopic Cholecystectomy
An observational study of Postoperative Pain, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
the investigators use usually a plane block for postoperative analgesia; if it suitable. İn laparoscopic patients; investigators used oblique subcostal transversus abdominis plane block; formerly. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ostap and SIPB plus rectus sheath block
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 26 Nov 2018
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: adult patients undergoing laparoscopic cholecystectomy, ASA I-II-III patients.
Who may be able to join
- patients undergoed laparoscopic cholecystectomy ASA I-II-III
Who cannot join
- patients used another block or block combination
- no block performed patients
- procedure converted to open procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Maltepe University faculty of medicine
Istanbul, 34090
About this study
Official title: Ultrasound-guided Oblique Subcostal Transversus Abdominis Plane Block Versus Serratus Intercostal Plane Block Plus Rectus Sheath Block; in Laparoscopic Cholecystectomy
the investigators use usually a plane block for postoperative analgesia; if it suitable. İn laparoscopic patients; investigators used oblique subcostal transversus abdominis plane block; formerly. But in the last few months, the investigators have performed serratus intercostal (BRILMA) block with bilateral rectus sheath block. in this retrospective evaluation, the aim of the retrospective evaluation is to determine the effects of two block on postoperative opioid consumption.
- Conditions
- Postoperative Pain
- Being tested
- ostap, SIPB plus rectus sheath block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ostapProcedure or surgery
this block is performed under general anesthesia in this patients for postoperative analgesia.
SIPB plus rectus sheath blockProcedure or surgery
this block is performed under general anesthesia in this patients for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| OSTAP | Data of patients (performed oblique subcostal transversus abdominis plane-OSTAP- block for postoperative analgesia in laparoscopic cholecystectomy) will be collected. Receives: Procedure: ostap | |
| SIPB plus rectus sheath block | Data of patients (performed serratus intercostal plane block-SIPB- plus rectus sheath block for postoperative analgesia in laparoscopic cholecystectomy) will be collected. Receives: Procedure: SIPB plus rectus sheath block |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using
Measured: 24 hours
Secondary outcomes (1)
Pain assessed by NRS
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 May 2018
- Primary completion1 Nov 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asst. Prof. Serkan Tulgar, M.D., Maltepe University
- Investigators
- serkan tulgar, Principal investigator, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751540
- Sponsor's protocol ID
- Blocks in LC
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Y, Shi K, Xia Y, Zhang X, Papadimos TJ, Xu X, Wang Q. Sensory Assessment and Regression Rate of Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Volunteers. Reg Anesth Pain Med. 2018 Feb;43(2):174-179. doi: 10.1097/AAP.0000000000000715.
PubMed 29278604Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.
PubMed 29789137
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Oblique Subcostal Transversus Abdominis Plane Block Versus Serratus Intercostal Plane Block Plus Rectus Sheath Block; in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03751540
- Acronym / sponsor ID
- Blocks in LC
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 23 Nov 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.
the investigators use usually a plane block for postoperative analgesia; if it suitable. İn laparoscopic patients; investigators used oblique subcostal transversus abdominis plane block; formerly. But in the last few months, the investigators have performed serratus intercostal (BRILMA) block with bilateral rectus sheath block. in this retrospective evaluation, the aim of the retrospective evaluation is to determine the effects of two block on postoperative opioid consumption.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSTAP | – | Procedure: ostapData of patients (performed oblique subcostal transversus abdominis plane-OSTAP- block for postoperative analgesia in laparoscopic cholecystectomy) will be collected. |
| SIPB plus rectus sheath block | – | Procedure: SIPB plus rectus sheath blockData of patients (performed serratus intercostal plane block-SIPB- plus rectus sheath block for postoperative analgesia in laparoscopic cholecystectomy) will be collected. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients undergoing laparoscopic cholecystectomy, ASA I-II-III patients.
Key inclusion criteria (1 listed)
- patients undergoed laparoscopic cholecystectomy ASA I-II-III
Key exclusion criteria (3 listed)
- patients used another block or block combination
- no block performed patients
- procedure converted to open procedure
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 |
|---|---|---|
| ostapthis block is performed under general anesthesia in this patients for postoperative analgesia. | Procedure or surgery | OSTAP |
| SIPB plus rectus sheath blockthis block is performed under general anesthesia in this patients for postoperative analgesia. | Procedure or surgery | SIPB plus rectus sheath block |
Primary outcome
opioid consumption
Time frame: 24 hours
Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using
1 secondary outcome
Pain assessed by NRS
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Background: PubMed 29278604Chen Y, Shi K, Xia Y, Zhang X, Papadimos TJ, Xu X, Wang Q. Sensory Assessment and Regression Rate of Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Volunteers. Reg Anesth Pain Med. 2018 Feb;43(2):174-179. doi: 10.1097/AAP.0000000000000715.
- Background: PubMed 29789137Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.
- 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.
serkan tulgar principal investigator
Maltepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Maltepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751540, which also lists 2 linked publications.
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 27 Nov 2018.