AnalgesiaNCT06253741
Rhomboid Intercostal and Subserratus / Paravertebral Block
A study testing PARAVERTEBRAL BLOCK and RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK in people with Analgesia and Thoracic, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain is a significant concern following video-assisted thoracoscopic surgery (VATS). Pain after thoracic surgery not only causes a strong stress reaction and adverse emotional experience but also affects postoperative rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Thoracic, Anesthesia
- What is being tested?
- PARAVERTEBRAL BLOCK and RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Aug 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
- Planned for VATS
- American Society of Anesthesiologists (ASA) class I and II
- Patients aged between 18-80
Who cannot join
- Contraindications to local anesthetic allergy or bupivacaine
- Known or suspected coagulopathy
- Injection site infection
- History of thoracic surgery
- Severe neurological or psychiatric disorder
- Severe cardiovascular disease
Show all 9Show fewer
- Liver failure
- Renal failure (glomerular filtration rate <15 ml/min/1.73 m2)
- Chronic opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Comparison of Rhomboid Intercostal and Subserratus Plane Blocks Applied for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery With Thoracic Paravertebral Block"
Postoperative pain is a significant concern following video-assisted thoracoscopic surgery (VATS). Pain after thoracic surgery not only causes a strong stress reaction and adverse emotional experience but also affects postoperative rehabilitation. Hence, different analgesia techniques, including local anesthetic infiltration, intercostal nerve block, paravertebral block, and thoracic epidural anesthesia, have been described to attenuate the intensity of acute postoperative painparavertebral block (PVB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after video-assisted thoracoscopic surgery (VATS). This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of ultra- sound-guided PVB and RISS block after video-assisted thoracoscopic surgery.
- Conditions
- Analgesia, Thoracic, Anesthesia
- Being tested
- PARAVERTEBRAL BLOCK, RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK, PLACEBO
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARAVERTEBRAL BLOCKProcedure or surgery
Also called PVB
Hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes
RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCKProcedure or surgery
Also called RISS
Hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes.
PLACEBOProcedure or surgery
Also called PG
Hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PARAVERTEBRAL BLOCK | Active comparator | After induction of general anesthesia and endotracheal intubation in the operating room, following the positioning of the patient for surgery, ultrasound-guided paravertebral block (PVB) will be routinely performed in our clinic using 0.25% bupivacaine solution at a dose of 0.5 ml/kg. Receives: Procedure: PARAVERTEBRAL BLOCK |
| RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK | Active comparator | After induction of general anesthesia and endotracheal intubation in the operating room, following the positioning of the patient for surgery, rhomboid intercostal block with sub-serratus plane block (RISS) will be routinely performed in our clinic using 0.25% bupivacaine solution at a dose of 0.5 ml/kg under ultrasound guidance. Receives: Procedure: RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK |
| PLACEBO | Placebo comparator | The group without any peripheral block application will be included Receives: Procedure: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scores
The primary outcome of this study was to compare the analgesia of paravertebral block versus rhomboid intercostal and subserratus plane block in VATS surgery.
Measured: up to 24 hours
Secondary outcomes (3)
morphine consumption
The secondary outcome measure in this study was 24-hour morphine consumption.
Measured: up to 24 hours
first analgesia requirement
Secondary outcome measures included time to first request for morphine
Measured: up to 24 hours
Side effects
Side effects associated with morphine consumption
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansabuncu, Uludag University
- Investigators
- SEDA CANSABUNCU, Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253741
- Sponsor's protocol ID
- 2022-17/23
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison of Rhomboid Intercostal and Subserratus Plane Blocks Applied for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery With Thoracic Paravertebral Block"
- ClinicalTrials.gov ID
- NCT06253741
- Acronym / sponsor ID
- 2022-17/23
- Conditions
- Analgesia, Thoracic, Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 12 Feb 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.
Postoperative pain is a significant concern following video-assisted thoracoscopic surgery (VATS). Pain after thoracic surgery not only causes a strong stress reaction and adverse emotional experience but also affects postoperative rehabilitation. Hence, different analgesia techniques, including local anesthetic infiltration, intercostal nerve block, paravertebral block, and thoracic epidural anesthesia, have been described to attenuate the intensity of acute postoperative painparavertebral block (PVB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after video-assisted thoracoscopic surgery (VATS). This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of ultra- sound-guided PVB and RISS block after video-assisted thoracoscopic surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PARAVERTEBRAL BLOCK | Active comparator | Procedure: PARAVERTEBRAL BLOCKAfter induction of general anesthesia and endotracheal intubation in the operating room, following the positioning of the patient for surgery, ultrasound-guided paravertebral block (PVB) will be routinely performed in our clinic using 0.25% bupivacaine solution at a dose of 0.5 ml/kg. |
| RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK | Active comparator | Procedure: RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCKAfter induction of general anesthesia and endotracheal intubation in the operating room, following the positioning of the patient for surgery, rhomboid intercostal block with sub-serratus plane block (RISS) will be routinely performed in our clinic using 0.25% bupivacaine solution at a dose of 0.5 ml/kg under ultrasound guidance. |
| PLACEBO | Placebo comparator | Procedure: PLACEBOThe group without any peripheral block application will be included |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned for VATS
- American Society of Anesthesiologists (ASA) class I and II
- Patients aged between 18-80
Key exclusion criteria (9 listed)
- Contraindications to local anesthetic allergy or bupivacaine
- Known or suspected coagulopathy
- Injection site infection
- History of thoracic surgery
- Severe neurological or psychiatric disorder
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 |
|---|---|---|
| PARAVERTEBRAL BLOCKAlso: PVBHemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes | Procedure or surgery | PARAVERTEBRAL BLOCK |
| RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCKAlso: RISSHemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes. | Procedure or surgery | RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK |
| PLACEBOAlso: PGHemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes. | Procedure or surgery | PLACEBO |
Primary outcome
VAS scores
Time frame: up to 24 hours
The primary outcome of this study was to compare the analgesia of paravertebral block versus rhomboid intercostal and subserratus plane block in VATS surgery.
3 secondary outcomes
morphine consumption
Time frame: up to 24 hours
first analgesia requirement
Time frame: up to 24 hours
Side effects
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- 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.
SEDA CANSABUNCU principal investigator
Uludag 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 PARAVERTEBRAL BLOCK and RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK in people with Analgesia and Thoracic, run by Uludag 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 9 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 12 Feb 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SEDA CANSABUNCU (+9002242940000, sedacansabuncu@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS scores (time frame: up to 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 12 Feb 2024.