CholecystectomyNCT04761029
Rhomboid Intercostal and Subserratus Plane Block
A study testing RIIS and Tramadol in people with Cholecystectomy and Postoperative Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic surgery is frequently used today for abdominal region operations. Laparoscopy has become the preferred treatment for cholecystectomy. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain despite the multimodal analgesic regimen. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cholecystectomy, Postoperative Pain, Nerve Block
- What is being tested?
- RIIS and Tramadol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jul 2020
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology physical status I and II and who gave consent for the blocks were included in the study
Who cannot join
- bleeding disorders,
- mental incapacity,
- known allergy to the local anesthetics,
- body mass index ≥35 kg/m2
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110
About this study
Official title: Investigation of the Efficacy of Unilateral Rhomboid Intercostal and Subserratus Plane Block Application for Postoperative Analgesia in Laparoscopic Cholecystectomy
Laparoscopic surgery is frequently used today for abdominal region operations. Laparoscopy has become the preferred treatment for cholecystectomy. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain despite the multimodal analgesic regimen. For this type of surgery, many different field blocks have been used for postoperative analgesia.
Read the detailed description
In this study, the analgesic efficacy of Unilateral Rhomboid intercostal and subserratus block was investigated in patients who had laparoscopic cholecystectomy.
- Conditions
- Cholecystectomy, Postoperative Pain, Nerve Block
- Being tested
- RIIS, Tramadol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIISOther
unilateral Rhomboid intercostal and subserratus block
TramadolDrug
intravenous patient-controlled analgesia (tramadol)
| Study group | Role | What they receive |
|---|---|---|
| grup R | Active comparator | Unilateral Rhomboid intercostal and subserratus block + intravenous patient-controlled analgesia Receives: Other: RIIS; Drug: Tramadol |
| Group P | Placebo comparator | intravenous patient-controlled analgesia Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
tramadol consumption
tramadol consumption
Measured: Postoperative 24 hours
Secondary outcomes (5)
Numeric Rating Scale rest
Numeric Rating Scale was used for pain.Pain intensity was measured using Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: postoperative 24 hours
Numeric Rating Scale during movement
Numeric Rating Scale was used for pain.Pain intensity was measured using Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Postoperative 24 hours
additional analgesic use
additional analgesic use
Measured: Postoperative 24 hours
side effect profile
side effect profile (Nausea and vomiting)
Measured: Postoperative 24 hours
sensorial dermatomal block-level
Dermatomal dispersion of sensorial block to the cold stimulus.
Measured: 30 minutes after the block administration and at the postoperative 2nd hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jan 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- retrospective
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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, Assoc. PhD., Principal investigator, Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761029
- Sponsor's protocol ID
- 2011-KAEK-25
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Unilateral Rhomboid Intercostal and Subserratus Plane Block Application for Postoperative Analgesia in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04761029
- Acronym / sponsor ID
- 2011-KAEK-25
- Conditions
- Cholecystectomy, Postoperative Pain, Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 18 Feb 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 surgery is frequently used today for abdominal region operations. Laparoscopy has become the preferred treatment for cholecystectomy. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain despite the multimodal analgesic regimen. For this type of surgery, many different field blocks have been used for postoperative analgesia.
Detailed description
In this study, the analgesic efficacy of Unilateral Rhomboid intercostal and subserratus block was investigated in patients who had laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- retrospective
| Arm | Type | Receives |
|---|---|---|
| grup R | Active comparator | Other: RIIS, Drug: TramadolUnilateral Rhomboid intercostal and subserratus block + intravenous patient-controlled analgesia |
| Group P | Placebo comparator | Drug: Tramadolintravenous patient-controlled analgesia |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiology physical status I and II and who gave consent for the blocks were included in the study
Key exclusion criteria (4 listed)
- bleeding disorders,
- mental incapacity,
- known allergy to the local anesthetics,
- body mass index ≥35 kg/m2
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 |
|---|---|---|
| RIISunilateral Rhomboid intercostal and subserratus block | Other | grup R |
| Tramadolintravenous patient-controlled analgesia (tramadol) | Drug | Group P, grup R |
Primary outcome
tramadol consumption
Time frame: Postoperative 24 hours
tramadol consumption
5 secondary outcomes
Numeric Rating Scale rest
Time frame: postoperative 24 hours
Numeric Rating Scale during movement
Time frame: Postoperative 24 hours
additional analgesic use
Time frame: Postoperative 24 hours
side effect profile
Time frame: Postoperative 24 hours
sensorial dermatomal block-level
Time frame: 30 minutes after the block administration and at the postoperative 2nd hour
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 18 Feb 2021.
Related trials for Cholecystectomy
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
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Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients
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RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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Timing of CHolecystectomy In Severe PAncreatitis
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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, Assoc. PhD. principal investigator
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIIS and Tramadol in people with Cholecystectomy and Postoperative Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 4 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 18 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
tramadol consumption (time frame: Postoperative 24 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 18 Feb 2021.