Laparoscopic CholecystectomyPhase 4NCT05021822
The Effect of Erector Spinae Block on Diaphragma Movement
A Phase 4 study testing Erector spinae plane block in people with Laparoscopic Cholecystectomy and Acute Post-operative Pain, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy surgeries cause moderate/severe pain and thus can result in shallow breathing, atelectasis and increased opioid consumption in the early postoperative period which in turn cause a longer hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Acute Post-operative Pain, Respiratory Diaphragm
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Aug 2021to 18 Sep 2021
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 and 65
- Patients in American Society of Anesthesiologists Classification I or II
- Elective laparoscopic cholecystectomy surgery performed under general anesthesia
Who cannot join
- Patient refusal
- Patients who can not provide informed consent or with a known psychiatric disease
- Patients with a known allergy to study drugs
- Patients using anticoagulants and corticosteroids
- Patients with diaphragma hernia, chronic obstructive pulmonary disease, lung cancer
- Patients who are not able to use a patient controlled analgesia device
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi
Ankara, 06520
About this study
Official title: The Effect of Erector Spinae Plane Block on Diaphragma Movement in Laparoscopic Cholecystectomies
Laparoscopic cholecystectomy surgeries cause moderate/severe pain and thus can result in shallow breathing, atelectasis and increased opioid consumption in the early postoperative period which in turn cause a longer hospital stay. Erector spinae plane block has been shown to decrease lower thoracic pain after laparoscopic cholecystectomy surgeries. This study aims to investigate the effect of erector spinae plane block on opioid consumption and diaphragma movement after laparoscopic cholecystectomy surgeries.
- Being tested
- Erector spinae plane 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.
Erector spinae plane blockProcedure or surgery
Bilateral erector spinae plane block will be performed preoperatively under ultrasound guidance using 15 ml bupivacaine on each side
| Study group | Role | What they receive |
|---|---|---|
| Block Group | Active comparator | Not described Receives: Procedure: Erector spinae plane block |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Diaphragma excursion
The change of diaphragma excursion as measured by ultrasound in M-mode from the preoperative period to the postoperative period
Measured: Preoperative measurement-before the erector spina plane block application and postoperative measurement- 30 minutes after extubation
Change in Opioid consumption
To assess Tramadol consumption measured in mg postoperatively in the first 12 hours after the operation
Measured: Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour
Change in postoperative pain
Postoperative pain will be measured with visual analog scale and numeric scale in the first 12 hours after the operation
Measured: Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start26 Aug 2021
- Primary completion18 Sep 2021
- Study completion18 Sep 2021
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 Laparoscopic CholecystectomyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Ceren Köksoy, Ufuk University
- Investigators
- Ülkü C Köksoy, Ass. Prof., Principal investigator, Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021822
- Sponsor's protocol ID
- 2021-03
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petsas D, Pogiatzi V, Galatidis T, Drogouti M, Sofianou I, Michail A, Chatzis I, Donas G. Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a case report. J Pain Res. 2018 Sep 24;11:1983-1990. doi: 10.2147/JPR.S164489. eCollection 2018.
PubMed 30288093Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
PubMed 29913392
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erector Spinae Plane Block on Diaphragma Movement in Laparoscopic Cholecystectomies
- ClinicalTrials.gov ID
- NCT05021822
- Acronym / sponsor ID
- 2021-03
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 18 Sep 2021 (actual)
- Study completion
- 18 Sep 2021 (actual)
- First posted
- 26 Aug 2021 (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.
Laparoscopic cholecystectomy surgeries cause moderate/severe pain and thus can result in shallow breathing, atelectasis and increased opioid consumption in the early postoperative period which in turn cause a longer hospital stay. Erector spinae plane block has been shown to decrease lower thoracic pain after laparoscopic cholecystectomy surgeries. This study aims to investigate the effect of erector spinae plane block on opioid consumption and diaphragma movement after laparoscopic cholecystectomy surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block Group | Active comparator | Procedure: Erector spinae plane block |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages between 18 and 65
- Patients in American Society of Anesthesiologists Classification I or II
- Elective laparoscopic cholecystectomy surgery performed under general anesthesia
Key exclusion criteria (6 listed)
- Patient refusal
- Patients who can not provide informed consent or with a known psychiatric disease
- Patients with a known allergy to study drugs
- Patients using anticoagulants and corticosteroids
- Patients with diaphragma hernia, chronic obstructive pulmonary disease, lung cancer
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 |
|---|---|---|
| Erector spinae plane blockBilateral erector spinae plane block will be performed preoperatively under ultrasound guidance using 15 ml bupivacaine on each side | Procedure or surgery | Block Group |
Primary outcome
Change of Diaphragma excursion
Time frame: Preoperative measurement-before the erector spina plane block application and postoperative measurement- 30 minutes after extubation
The change of diaphragma excursion as measured by ultrasound in M-mode from the preoperative period to the postoperative period
Change in Opioid consumption
Time frame: Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour
To assess Tramadol consumption measured in mg postoperatively in the first 12 hours after the operation
Change in postoperative pain
Time frame: Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour
Postoperative pain will be measured with visual analog scale and numeric scale in the first 12 hours after the operation
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 10 Aug 2022.
- Background: PubMed 30288093Petsas D, Pogiatzi V, Galatidis T, Drogouti M, Sofianou I, Michail A, Chatzis I, Donas G. Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a case report. J Pain Res. 2018 Sep 24;11:1983-1990. doi: 10.2147/JPR.S164489. eCollection 2018.
- Background: PubMed 29913392Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
- 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.
Ülkü C Köksoy, Ass. Prof. principal investigator
Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erector spinae plane block in people with Laparoscopic Cholecystectomy and Acute Post-operative Pain, run by Ufuk 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 3 inclusion and 6 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 10 Aug 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of Diaphragma excursion (time frame: Preoperative measurement-before the erector spina plane block application and postoperative measurement- 30 minutes after extubation). The study lists 3 primary outcomes in all. 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 NCT05021822, 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 10 Aug 2022.