AnesthesiaNCT06449599
RIB for Perioperative Analgesia in CIED Patients
A study testing ultrasound and parenteral local anesthesia in people with Anesthesia and Postoperative Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Rhomboid intercostal plane block (RIB) has been described in the last decade. Various clinical applications have been found to provide hemithorax analgesia. The use of cardiac implantable electronic devices (CIEDs) is increasing due to comorbidities in the elderly population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Postoperative Pain, Arrhythmias, Cardiac
- What is being tested?
- ultrasound and parenteral local anesthesia
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jun 2024to 15 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age,
- no previous ICD or Pacemaker implantation attempt
- ASA ( American Society of Anesthesiologists ) score of 2-3,
- INR < 2.0 ,
- Signing the volunteer consent form,
- Patients who met the study criteria will be included in the study.
Who cannot join
- Morbidly obese patients (BMI>35 kg/m2),
- Advanced decompensated heart failure with New York Heart Association (NYHA) stage 4,
- Having severe chronic obstructive pulmonary disease,
- Allergy to the prescribed medications ,
- Those who have a skin infection or lesion in the area to be blocked,
- Cannot be communicated and cannot be given a position,
Show all 10Show fewer
- Severe psychosis and progressive neurological deficits and muscle disease,
- ICD/ Pacemaker revision or upgrade to be made,
- ICD battery replacement
- Pregnant patients will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Rhomboid Intercostal Plane Block on Local Anesthesia in Cardiac Implantable Electronic Device Implantation: A Randomized Controlled Clinical Trial
Rhomboid intercostal plane block (RIB) has been described in the last decade. Various clinical applications have been found to provide hemithorax analgesia. The use of cardiac implantable electronic devices (CIEDs) is increasing due to comorbidities in the elderly population. Increased myocardial stress with pain in these patients may increase the frequency of adverse cardiac events. Therefore, perioperative pain management ensures patient welfare, reduces complications, and maintains stable hemodynamic values. In this study, we aimed to evaluate the outcomes of RIB in terms of perioperative analgesia and patient and physician satisfaction in patients undergoing CIED.
Read the detailed description
In accordance with the study design, a randomization list for the two groups is generated by an independent individual using a computer-assisted program (www.randomizer.org). Equal numbers of participants are assigned to either the intervention or control group in a 1:1 ratio. Patients included in the study will be randomized into two groups of 25 patients each. One group (local anaesthesia group - LAG) will receive only local anaesthesia (prilocaine 2%) as per the standard procedure of the institution. The other group (RIB group - RIBG) will receive RIB in addition to the standard procedure. Demographic and clinical data regarding the patients and the procedures performed will be recorded. Information about the first and second rescue treatments in cases of pain during the procedure, as well as the first and second rescue treatments during postoperative follow-up, will also be documented in the same database. Pain levels during the procedure, at the end of the procedure, and at 3, 6, 12, and 24 hours postoperatively will be assessed using the NRS-11. Patient and physician satisfaction will be evaluated using a five-point Likert scale. This study aims to evaluate the efficacy of RIB in patients undergoing CIED implantation by performing pain assessments with the Numeric Rating Scale-11 (NRS-11) during the procedure and the postoperative period. As a secondary outcome, patient and physician satisfaction levels will be assessed during the procedure.
- Conditions
- Anesthesia, Postoperative Pain, Arrhythmias, Cardiac
- Being tested
- ultrasound, parenteral local anesthesia
- Keywords
- rhomboid intercostal plane block,, postoperative analgesia, cardiac electrophysiology, cardiac implantable electronic devices, arrhythmia, satisfaction
- Medical subject headings
- Pain, Postoperative, Arrhythmias, Cardiac, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
Local anesthesia 400 mg(20ml) prilocaine 2% to surgical field and additionally ultrasound-guided RIB with 0,25% bupivacaine 20 ml will be applied to the patients who will be inserted cardiac implantable electronic devices An additional 100 mg of prilocaine will be administered as the first-line rescue treatment if the intraoperative NRS-11 score was ≥4.If the patient has an NRS-11 score of ≥4 again during the procedure,100 mg of prilocaine will be administered again as the second rescue treatment.
In the postoperative follow-up of the patients,1 g of paracetamol will be administered IV as an infusion for 20 minutes as the first rescue treatment if the patients have an NRS-11 pain score of ≥4. Two hours after IV paracetamol,if the NRS-11 score≥4, 50 mg of tramadol HCL will be administered IV as the second rescue treatment.In addition, when the NRS score is ≥4 at follow-up, paracetamol 1 g, IV will be administered with dosing intervals not shorter than 6 hours.
parenteral local anesthesiaProcedure or surgery
Only local anesthesia 400 mg(20ml) prilocaine 2% prilocaine to surgical field will be applied to the patients who will be inserted cardiac implantable electronic devices.
An additional 100 mg of prilocaine will be administered as the first-line rescue treatment if the intraoperative NRS-11 score was ≥4.If the patient has an NRS-11 score of ≥4 again during the procedure,100 mg of prilocaine will be administered again as the second rescue treatment.
In the postoperative follow-up of the patients,1 g of paracetamol will be administered IV as an infusion for 20 minutes as the first rescue treatment if the patients have an NRS-11 pain score of ≥4. Two hours after IV paracetamol,if the NRS-11 score≥4, 50 mg of tramadol HCL will be administered IV as the second rescue treatment.In addition, when the NRS score is ≥4 at follow-up, paracetamol (1 g, IV) will be administered with dosing intervals not shorter than 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| block group | Active comparator | local anesthesia will be applied to surgical field as a part of the routine procedure and additionally rhomboid intercostal plane block will be applied Receives: Device: ultrasound |
| control group | Sham comparator | only local anesthesia will be applied to surgical field as a part of the routine procedure. Receives: Procedure: parenteral local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain will be assessed by the Numeric Rating Scale-11(NRS -11). Minimum pain score is point zero, maximum pain score is ten points.
to measure the analgesic efficacy of RIB
Measured: 4 months
Investigation patient and physician satisfaction assessed by 5-point Likert scale. One point represents strongly unsatisfied and 5 points represent strongly satisfied.
For patient and physician satisfaction;5-point Likert scale will be used.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start4 Jun 2024
- Primary completion15 Oct 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerem Erkalp, MD, Prof, Istanbul University - Cerrahpasa
- Investigators
- Kerem Erkalp, Study chair, Proffessor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449599
- Sponsor's protocol ID
- 015
- Status last verified
- May 2025
- First submitted
- 27 May 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altun G, Esin A, Ozsahin Y, Arslan S, Erkalp K, Salihoglu Z. Outcomes of rhomboid intercostal plane block on local anaesthesia in cardiac implantable electronic device implantation: a randomized controlled clinical trial. BMC Anesthesiol. 2025 Jul 1;25(1):328. doi: 10.1186/s12871-025-03206-8.
PubMed 40597579
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Rhomboid Intercostal Plane Block on Local Anesthesia in Cardiac Implantable Electronic Device Implantation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06449599
- Acronym / sponsor ID
- 015
- Conditions
- Anesthesia, Postoperative Pain, Arrhythmias, Cardiac
- Keywords
- rhomboid intercostal plane block,, postoperative analgesia, cardiac electrophysiology, cardiac implantable electronic devices, arrhythmia, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 10 Jun 2024 (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.
Rhomboid intercostal plane block (RIB) has been described in the last decade. Various clinical applications have been found to provide hemithorax analgesia. The use of cardiac implantable electronic devices (CIEDs) is increasing due to comorbidities in the elderly population. Increased myocardial stress with pain in these patients may increase the frequency of adverse cardiac events. Therefore, perioperative pain management ensures patient welfare, reduces complications, and maintains stable hemodynamic values. In this study, we aimed to evaluate the outcomes of RIB in terms of perioperative analgesia and patient and physician satisfaction in patients undergoing CIED.
Detailed description
In accordance with the study design, a randomization list for the two groups is generated by an independent individual using a computer-assisted program (www.randomizer.org). Equal numbers of participants are assigned to either the intervention or control group in a 1:1 ratio. Patients included in the study will be randomized into two groups of 25 patients each. One group (local anaesthesia group - LAG) will receive only local anaesthesia (prilocaine 2%) as per the standard procedure of the institution. The other group (RIB group - RIBG) will receive RIB in addition to the standard procedure. Demographic and clinical data regarding the patients and the procedures performed will be recorded. Information about the first and second rescue treatments in cases of pain during the procedure, as well as the first and second rescue treatments during postoperative follow-up, will also be documented in the same database. Pain levels during the procedure, at the end of the procedure, and at 3, 6, 12, and 24 hours postoperatively will be assessed using the NRS-11. Patient and physician satisfaction will be evaluated using a five-point Likert scale. This study aims to evaluate the efficacy of RIB in patients undergoing CIED implantation by performing pain assessments with the Numeric Rating Scale-11 (NRS-11) during the procedure and the postoperative period. As a secondary outcome, patient and physician satisfaction levels will be assessed during the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| block group | Active comparator | Device: ultrasoundlocal anesthesia will be applied to surgical field as a part of the routine procedure and additionally rhomboid intercostal plane block will be applied |
| control group | Sham comparator | Procedure: parenteral local anesthesiaonly local anesthesia will be applied to surgical field as a part of the routine procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- over 18 years of age,
- no previous ICD or Pacemaker implantation attempt
- ASA ( American Society of Anesthesiologists ) score of 2-3,
- INR < 2.0 ,
- Signing the volunteer consent form,
Key exclusion criteria (10 listed)
- Morbidly obese patients (BMI>35 kg/m2),
- Advanced decompensated heart failure with New York Heart Association (NYHA) stage 4,
- Having severe chronic obstructive pulmonary disease,
- Allergy to the prescribed medications ,
- Those who have a skin infection or lesion in the area to be blocked,
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 |
|---|---|---|
| ultrasoundLocal anesthesia 400 mg(20ml) prilocaine 2% to surgical field and additionally ultrasound-guided RIB with 0,25% bupivacaine 20 ml will be applied to the patients who will be inserted cardiac implantable electronic devices An additional 100 mg of prilocaine will be administered as the first-line rescue treatment if the intraoperative NRS-11 score was ≥4.If the patient has an NRS-11 score of ≥4 again during the procedure,100 mg of prilocaine will be administered again as the second rescue treatment. In the postoperative follow-up of the patients,1 g of paracetamol will be administered IV as an infusion for 20 minutes as the first rescue treatment if the patients have an NRS-11 pain score of ≥4. Two hours after IV paracetamol,if the NRS-11 score≥4, 50 mg of tramadol HCL will be administered IV as the second rescue treatment.In addition, when the NRS score is ≥4 at follow-up, paracetamol 1 g, IV will be administered with dosing intervals not shorter than 6 hours. | Device | block group |
| parenteral local anesthesiaOnly local anesthesia 400 mg(20ml) prilocaine 2% prilocaine to surgical field will be applied to the patients who will be inserted cardiac implantable electronic devices. An additional 100 mg of prilocaine will be administered as the first-line rescue treatment if the intraoperative NRS-11 score was ≥4.If the patient has an NRS-11 score of ≥4 again during the procedure,100 mg of prilocaine will be administered again as the second rescue treatment. In the postoperative follow-up of the patients,1 g of paracetamol will be administered IV as an infusion for 20 minutes as the first rescue treatment if the patients have an NRS-11 pain score of ≥4. Two hours after IV paracetamol,if the NRS-11 score≥4, 50 mg of tramadol HCL will be administered IV as the second rescue treatment.In addition, when the NRS score is ≥4 at follow-up, paracetamol (1 g, IV) will be administered with dosing intervals not shorter than 6 hours. | Procedure or surgery | control group |
Primary outcome
The pain will be assessed by the Numeric Rating Scale-11(NRS -11). Minimum pain score is point zero, maximum pain score is ten points.
Time frame: 4 months
to measure the analgesic efficacy of RIB
Investigation patient and physician satisfaction assessed by 5-point Likert scale. One point represents strongly unsatisfied and 5 points represent strongly satisfied.
Time frame: 4 months
For patient and physician satisfaction;5-point Likert scale will be used.
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 14 May 2025.
- Derived from this study: PubMed 40597579Altun G, Esin A, Ozsahin Y, Arslan S, Erkalp K, Salihoglu Z. Outcomes of rhomboid intercostal plane block on local anaesthesia in cardiac implantable electronic device implantation: a randomized controlled clinical trial. BMC Anesthesiol. 2025 Jul 1;25(1):328. doi: 10.1186/s12871-025-03206-8.
- 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.
Kerem Erkalp study chair
Proffessor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and parenteral local anesthesia in people with Anesthesia and Postoperative Pain, run by Istanbul University - Cerrahpasa 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 6 inclusion and 10 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 14 May 2025. 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?
The pain will be assessed by the Numeric Rating Scale-11(NRS -11). Minimum pain score is point zero, maximum pain score is ten points. (time frame: 4 months). The study lists 2 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 NCT06449599, which also lists 1 linked publication.
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 14 May 2025.