Lung DiseasesNCT04428216
Rhomboid Intercostal Block for Video Assisted Thoracic Surgery
A study testing Group RIB in people with Lung Diseases, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Group RIB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2020to 1 Jun 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for VATS under general anesthesia
Who cannot join
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
- patients who do not accept the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block for Pain Management Following Video Assisted Thoracic Surgery
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption.
Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. It has been reported that RIB may provide effective analgesia management for several surgeries like thoracotomy.
Read the detailed description
Following Video Assisted Thoracic Surgery Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. The advantages of VATS prodecures compared with open thoracotomy are rapid recovery, short hospital stay and low complication risk. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption.
Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several surgeries like thoracotomy.
The aim of this study is to evaluate the efficacy US-guided Rhomboid intercostal block compared to no intervention control group for postoperative analgesia management after VATS. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting) and complications due to block (pneumothorax, hematoma etc).
- Conditions
- Lung Diseases
- Being tested
- Group RIB
- Keywords
- Video Assisted Thoracic Surgery, Postoperative pain management, Rhomboid intercostal block
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group RIBOther
In group RIB, RIB block will be performed. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
| Study group | Role | What they receive |
|---|---|---|
| Group RIB = Rhomboid intercostal block group | Active comparator | In group RIB, RIB block will be performed with patients in the lateral decubitus position. The linear high frequency probe will be placed in sagittal plane medially on the medial border of the scapula at T5-6 level. The trapezius muscle, rhomboid major muscle, intercostal muscle, ribs and the pleura will be visualized. The needle will be inserted into the fascial plane between the rhomboid major and intercostal muscles in a cranio-caudal direction. A dose of 20 ml 0,25% bupivacaine will be injected into the fascial plane. Receives: Other: Group RIB |
| Group C = Control group | No intervention | Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
The primary aim is to compare perioperative and postoperative opioid consumption
Measured: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours
Secondary outcomes (1)
Pain scores (Visual analogue scores-VAS)
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded
Measured: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start7 Jul 2020
- Primary completion30 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two models for this study. The first group is rhomboid intercostal block group. The second one is no intervention control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428216
- Sponsor's protocol ID
- Medipol Hospital 13
- Status last verified
- Aug 2022
- First submitted
- 9 Jun 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD
Publications
Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.
PubMed 27291611Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. The usage of single-shot ultrasound guided rhomboid intercostal block for analgesia after thoracotomy: Clinical experience in two patients. J Clin Anesth. 2019 Sep;56:98-99. doi: 10.1016/j.jclinane.2019.01.032. Epub 2019 Jan 29. No abstract available.
PubMed 30708149Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. No abstract available.
PubMed 30851503
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block for Pain Management Following Video Assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04428216
- Acronym / sponsor ID
- Medipol Hospital 13
- Conditions
- Lung Diseases
- Keywords
- Video Assisted Thoracic Surgery, Postoperative pain management, Rhomboid intercostal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 11 Jun 2020 (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.
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption.
Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. It has been reported that RIB may provide effective analgesia management for several surgeries like thoracotomy.
Detailed description
Following Video Assisted Thoracic Surgery Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. The advantages of VATS prodecures compared with open thoracotomy are rapid recovery, short hospital stay and low complication risk. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption.
Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several surgeries like thoracotomy.
The aim of this study is to evaluate the efficacy US-guided Rhomboid intercostal block compared to no intervention control group for postoperative analgesia management after VATS. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting) and complications due to block (pneumothorax, hematoma etc).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are two models for this study. The first group is rhomboid intercostal block group. The second one is no intervention control group
| Arm | Type | Receives |
|---|---|---|
| Group RIB = Rhomboid intercostal block group | Active comparator | Other: Group RIBIn group RIB, RIB block will be performed with patients in the lateral decubitus position. The linear high frequency probe will be placed in sagittal plane medially on the medial border of the scapula at T5-6 level. The trapezius muscle, rhomboid major muscle, intercostal muscle, ribs and the pleura will be visualized. The needle will be inserted into the fascial plane between the rhomboid major and intercostal muscles in a cranio-caudal direction. A dose of 20 ml 0,25% bupivacaine will be injected into the fascial plane. |
| Group C = Control group | No intervention | –Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for VATS under general anesthesia
Key exclusion criteria (6 listed)
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
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 |
|---|---|---|
| Group RIBIn group RIB, RIB block will be performed. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. | Other | Group RIB = Rhomboid intercostal block group |
Primary outcome
Opioid consumption
Time frame: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours
The primary aim is to compare perioperative and postoperative opioid consumption
1 secondary outcome
Pain scores (Visual analogue scores-VAS)
Time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.
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 11 Aug 2022.
- Background: PubMed 27291611Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.
- Background: PubMed 30708149Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. The usage of single-shot ultrasound guided rhomboid intercostal block for analgesia after thoracotomy: Clinical experience in two patients. J Clin Anesth. 2019 Sep;56:98-99. doi: 10.1016/j.jclinane.2019.01.032. Epub 2019 Jan 29. No abstract available.
- Background: PubMed 30851503Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. No abstract available.
- Individual participant dataSharing planned: No. We will not plan to share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group RIB in people with Lung Diseases, run by Medipol 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 2 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 11 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.
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?
Opioid consumption (time frame: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours). 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 NCT04428216, which also lists 3 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 11 Aug 2022.