Minimal Invasive Heart SurgeryNCT05861804
Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery
A study testing Rhomboid Intercostal Nerve Block in people with Minimal Invasive Heart Surgery and Rhomboid Intercostal Nerve Block, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to test the analgesic efficacy of rhomboid intercostal nerve block (RINB) in patients undergoing minimal invasive heart surgery (MIHS). The main questions it aims to answer are: How will the total perioperative opioid consumption of the patients receiving RINB change? How will RINB… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Minimal Invasive Heart Surgery, Rhomboid Intercostal Nerve Block
- What is being tested?
- Rhomboid Intercostal Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the age of 18-80 undergoing minimal invasive heart surgery
Who cannot join
- Allergy to local anaesthetics
- Chronic opioid use history
- Patients with psychiatric disorders
- Patients who are not open to communication
- Patients with chronic organ failure
- Patients that do not give consent
- Patients that need emergency surgery within the first 24 hours of the initial surgery
Trial locations and contacts
1 site in 1 country.
Yasemin Sincer, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koc University
Istanbul, 34010
Kamil Darçın, +905055895099, kdarcin@ku.edu.tr
Yasemin Sincer, +90512040834, sincer.yasemin@gmail.com
About this study
Official title: Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to test the analgesic efficacy of rhomboid intercostal nerve block (RINB) in patients undergoing minimal invasive heart surgery (MIHS). The main questions it aims to answer are:
- How will the total perioperative opioid consumption of the patients receiving RINB change?
- How will RINB effect the patients' numeric rating scores for pain in the postoperative 24-hour period?
- How will RINB effect the postoperative extubation times?
- How will RINB effect the length of intensive care unit (ICU) stays on the postoperative period?
- How will RINB effect the incidence of opioid related side effects?
Read more
Participants will be divided in two groups:
- Block group will receive a RINB before the surgery.
- Control group will not receive any nerve block. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and ICU length of stay of the patients receiving RINB for minimal invasive heart surgery.
The hypothesis of this study is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively.
Read the detailed description
Rhomboid intercostal nerve block (RINB) was first defined by Elsharkawy et al in 2016 proposing to provide analgesia for both the anterior and posterior hemithorax. Minimal invasive heart surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing MIHS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. This study aims to assess the analgesic efficacy of RINB for MIHS. The hypothesis is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores, respiratory parameters and ICU length of stay of the participants will be recorded. Participants will be divided in two groups. The block-group will receive a RINB preoperatively in the operating room. The control-group will not receive any nerve block. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, postoperative extubation times, length of ICU stays, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated.
- Being tested
- Rhomboid Intercostal Nerve Block
- Keywords
- rhomboid intercostal nerve block, minimal invasive heart surgery, cardiac anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid Intercostal Nerve BlockProcedure or surgery
Before the induction of general anesthesia, under aseptic conditions, rhomboid intercostal nerve block will be performed with a single dose of 20 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Block group | Experimental | Participants who will be receiving a rhomboid intercostal nerve block Receives: Procedure: Rhomboid Intercostal Nerve Block |
| Control group | No intervention | Participant who will not be receiving any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage
Measured: 24 hours post-surgery
Secondary outcomes (4)
Numeric rating scale scores for pain
the scale between 0: no pain and 10:highes pain answered by the participants
Measured: 24 hours post-surgery
Extubation time after surgery
measured in hours
Measured: 24 hours post-surgery
Length of intensive care unit stay
measured in hours
Measured: 1 week follow up after surgery
Opioid related side effects
Nausea, vomiting, pruritis, respiratory depression assessed by yes/no questions
Measured: 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jun 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Invasive Heart SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamil Darcin, Koç University
- Investigators
- Kamil Darçın, MD, Study director, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861804
- Sponsor's protocol ID
- 2022.462.IRB1.182
- Status last verified
- Mar 2024
- First submitted
- 7 May 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05861804
- Acronym / sponsor ID
- 2022.462.IRB1.182
- Keywords
- rhomboid intercostal nerve block, minimal invasive heart surgery, cardiac anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 17 May 2023 (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 goal of this clinical trial is to test the analgesic efficacy of rhomboid intercostal nerve block (RINB) in patients undergoing minimal invasive heart surgery (MIHS). The main questions it aims to answer are:
- How will the total perioperative opioid consumption of the patients receiving RINB change?
- How will RINB effect the patients' numeric rating scores for pain in the postoperative 24-hour period?
- How will RINB effect the postoperative extubation times?
- How will RINB effect the length of intensive care unit (ICU) stays on the postoperative period?
- How will RINB effect the incidence of opioid related side effects?
Participants will be divided in two groups:
- Block group will receive a RINB before the surgery.
- Control group will not receive any nerve block. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and ICU length of stay of the patients receiving RINB for minimal invasive heart surgery.
The hypothesis of this study is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively.
Detailed description
Rhomboid intercostal nerve block (RINB) was first defined by Elsharkawy et al in 2016 proposing to provide analgesia for both the anterior and posterior hemithorax. Minimal invasive heart surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing MIHS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. This study aims to assess the analgesic efficacy of RINB for MIHS. The hypothesis is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores, respiratory parameters and ICU length of stay of the participants will be recorded. Participants will be divided in two groups. The block-group will receive a RINB preoperatively in the operating room. The control-group will not receive any nerve block. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, postoperative extubation times, length of ICU stays, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block group | Experimental | Procedure: Rhomboid Intercostal Nerve BlockParticipants who will be receiving a rhomboid intercostal nerve block |
| Control group | No intervention | –Participant who will not be receiving any intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the age of 18-80 undergoing minimal invasive heart surgery
Key exclusion criteria (7 listed)
- Allergy to local anaesthetics
- Chronic opioid use history
- Patients with psychiatric disorders
- Patients who are not open to communication
- Patients with chronic organ failure
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 |
|---|---|---|
| Rhomboid Intercostal Nerve BlockBefore the induction of general anesthesia, under aseptic conditions, rhomboid intercostal nerve block will be performed with a single dose of 20 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist. | Procedure or surgery | Block group |
Primary outcome
Total opioid consumption
Time frame: 24 hours post-surgery
all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage
4 secondary outcomes
Numeric rating scale scores for pain
Time frame: 24 hours post-surgery
Extubation time after surgery
Time frame: 24 hours post-surgery
Length of intensive care unit stay
Time frame: 1 week follow up after surgery
Opioid related side effects
Time frame: 24 hours post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Yes
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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.
Yasemin Sincer, MD contact
Kamil Darçın, MD study director
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhomboid Intercostal Nerve Block in people with Minimal Invasive Heart Surgery and Rhomboid Intercostal Nerve Block, run by Koç 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 7 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 5 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamil Darçın, MD (+90 505 589 50 99, kdarcin@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption (time frame: 24 hours post-surgery). 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 5 Mar 2024.