Video Assisted Thoracoscopic SurgeryNCT07011069
Rhomboid Intercostal and Subserratus Plane Block vs Erector Spinae Plane Block in Video-Assisted Thoracoscopic Surgery
A study testing ESP block group and RISS block group in people with Video Assisted Thoracoscopic Surgery and Regional Block for Pain Control, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare the rhomboid intercostal subserratus plane block with the erector spinae plane block regarding their analgesic efficacy and effects on respiratory function for patients undergoing video-assisted thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Video Assisted Thoracoscopic Surgery, Regional Block for Pain Control, Regional Blocks
- What is being tested?
- ESP block group and RISS block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jun 2025to 15 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo VATS
- Who agrees to participate
- American Society of Anesthesiologists (ASA) physical status I, II, and III
- Elective surgery
- Age between 18 and 80 years
Who cannot join
- Local anesthetic allergy
- Who disagrees to participate
- ASA physical status IV and V
- Emergency surgery
- Hemorrhagic disease
- Thoracic vertebrae deformity
- Thoracic vertebrae surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Bursa City Hospital
Bursa, Nilufer, 16110
About this study
Official title: Comparison of the Efficacy of Rhomboid Intercostal and Subserratus Plane Block (RISS) Versus Erector Spinae Plane (ESP) Blocks in Video-Assisted Thoracoscopic Surgery (VATS) for Postoperative Pain Management and Respiratory Function
To compare the rhomboid intercostal subserratus plane block with the erector spinae plane block regarding their analgesic efficacy and effects on respiratory function for patients undergoing video-assisted thoracoscopic surgery.
Read the detailed description
Video-assisted thoracoscopic surgery (VATS) can be very painful and may lead to complications such as prolonged stays in intensive care, thromboembolic complications due to lack of early mobilization, chronic acute pain, and delirium if adequate analgesia is not provided. Therefore, using thoracic epidural, paravertebral, or regional blocks as part of multimodal analgesia is recommended to provide effective pain relief.
This study aims to compare the effects of the erector spinae plane block (ESP) and rhomboid intercostal subserratus plane block (RISS) on postoperative analgesia and the improvement of respiratory parameters in patients undergoing VATS. These two techniques may have different analgesic profiles with respect to somatic and visceral pain.
The primary objective is to evaluate the incidence of chest tube-site somatic pain at postoperative hour 2. Secondary objectives include the incidence of visceral pain, total analgesic consumption in the first 24 hours postoperatively, assessing resting and dynamic pain scores, triflow performance, complications, and length of hospital stay.
- Conditions
- Video Assisted Thoracoscopic Surgery, Regional Block for Pain Control, Regional Blocks, Pulmonary Functions
- Being tested
- ESP block group, RISS block group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP block groupProcedure or surgery
ESP blocks are performed for patients undergoing VATS.
RISS block groupProcedure or surgery
RISS blocks are performed for patients undergoing VATS.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received ESP block | Active comparator | Those who received the erector spinae plane block for postoperative pain management Receives: Procedure: ESP block group |
| Patients who received RISS block | Active comparator | Those who received the rhomboid intercostal subserratus plane block for postoperative pain management Receives: Procedure: RISS block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chest tube-site somatic pain
Proportion of participants with localized pain at the chest tube insertion site, elicited by palpation or chest tube manipulation. Somatic pain was recorded as present or absent.
Measured: At postoperative hour 2
Secondary outcomes (7)
Dynamic pain score
Postoperative pain scores during coughing and deep breathing are measured on a 11 cm scale, where "0" indicates no pain and "10" indicates the worst pain ever.
Measured: Postoperative first 24 hours.
Opioid consumption
Total opioid consumption within the first 24 hours in the postoperative period.
Measured: Postoperative first 24 hours.
Resting pain score
Postoperative pain scores during rest are measured on a 11 cm scale, where "0" indicates no pain and "10" indicates the worst pain ever.
Measured: Postoperative first 24 hours.
Pulmonary functions
Pulmonary functions are assessed using Triflow performance. Postoperative Triflow numbers (whether 1, 2, or 3 balls can be raised) for the patients are recorded.
Measured: Postoperative first 24 hours.
Complications
Complications regarding regional blocks and surgery (such as hematoma, pulmonary complications) are recorded.
Measured: From block administration to hospital discharge.
Hospital stay time
The length of hospital stay is recorded.
Measured: From surgery to hospital discharge.
Incidence of visceral pain
Proportion of participants reporting deep, poorly localized intrathoracic pain not confined to the incision or chest tube insertion site. Pain was recorded as present or absent.
Measured: At postoperative hour 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start9 Jun 2025
- Primary completion4 Dec 2025
- Study completion15 Dec 2025
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 Video Assisted Thoracoscopic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hande Gurbuz, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011069
- Sponsor's protocol ID
- 2024-11/4 24-AKD-209
- Status last verified
- Sep 2026
- First submitted
- 23 May 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets used in this research may be made available upon reasonable request to the corresponding author.
Publications
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
PubMed 28919152Elsharkawy H, Maniker R, Bolash R, Kalasbail P, Drake RL, Elkassabany N. Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation. Reg Anesth Pain Med. 2018 Oct;43(7):745-751. doi: 10.1097/AAP.0000000000000824.
PubMed 30169476Hsieh MJ, Wang KC, Liu HP, Gonzalez-Rivas D, Wu CY, Liu YH, Wu YC, Chao YK, Wu CF. Management of acute postoperative pain with continuous intercostal nerve block after single port video-assisted thoracoscopic anatomic resection. J Thorac Dis. 2016 Dec;8(12):3563-3571. doi: 10.21037/jtd.2016.12.30.
PubMed 28149550
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Rhomboid Intercostal and Subserratus Plane Block (RISS) Versus Erector Spinae Plane (ESP) Blocks in Video-Assisted Thoracoscopic Surgery (VATS) for Postoperative Pain Management and Respiratory Function
- ClinicalTrials.gov ID
- NCT07011069
- Acronym / sponsor ID
- 2024-11/4 24-AKD-209
- Conditions
- Video Assisted Thoracoscopic Surgery, Regional Block for Pain Control, Regional Blocks, Pulmonary Functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 8 Jun 2025 (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.
To compare the rhomboid intercostal subserratus plane block with the erector spinae plane block regarding their analgesic efficacy and effects on respiratory function for patients undergoing video-assisted thoracoscopic surgery.
Detailed description
Video-assisted thoracoscopic surgery (VATS) can be very painful and may lead to complications such as prolonged stays in intensive care, thromboembolic complications due to lack of early mobilization, chronic acute pain, and delirium if adequate analgesia is not provided. Therefore, using thoracic epidural, paravertebral, or regional blocks as part of multimodal analgesia is recommended to provide effective pain relief.
This study aims to compare the effects of the erector spinae plane block (ESP) and rhomboid intercostal subserratus plane block (RISS) on postoperative analgesia and the improvement of respiratory parameters in patients undergoing VATS. These two techniques may have different analgesic profiles with respect to somatic and visceral pain.
The primary objective is to evaluate the incidence of chest tube-site somatic pain at postoperative hour 2. Secondary objectives include the incidence of visceral pain, total analgesic consumption in the first 24 hours postoperatively, assessing resting and dynamic pain scores, triflow performance, complications, and length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who received ESP block | Active comparator | Procedure: ESP block groupThose who received the erector spinae plane block for postoperative pain management |
| Patients who received RISS block | Active comparator | Procedure: RISS block groupThose who received the rhomboid intercostal subserratus plane block for postoperative pain management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who will undergo VATS
- Who agrees to participate
- American Society of Anesthesiologists (ASA) physical status I, II, and III
- Elective surgery
- Age between 18 and 80 years
Key exclusion criteria (7 listed)
- Local anesthetic allergy
- Who disagrees to participate
- ASA physical status IV and V
- Emergency surgery
- Hemorrhagic disease
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 |
|---|---|---|
| ESP block groupESP blocks are performed for patients undergoing VATS. | Procedure or surgery | Patients who received ESP block |
| RISS block groupRISS blocks are performed for patients undergoing VATS. | Procedure or surgery | Patients who received RISS block |
Primary outcome
Incidence of chest tube-site somatic pain
Time frame: At postoperative hour 2
Proportion of participants with localized pain at the chest tube insertion site, elicited by palpation or chest tube manipulation. Somatic pain was recorded as present or absent.
7 secondary outcomes
Dynamic pain score
Time frame: Postoperative first 24 hours.
Opioid consumption
Time frame: Postoperative first 24 hours.
Resting pain score
Time frame: Postoperative first 24 hours.
Pulmonary functions
Time frame: Postoperative first 24 hours.
Complications
Time frame: From block administration to hospital discharge.
Hospital stay time
Time frame: From surgery to hospital discharge.
Incidence of visceral pain
Time frame: At postoperative hour 2
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 24 Sep 2026.
- Background: PubMed 28919152Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
- Background: PubMed 30169476Elsharkawy H, Maniker R, Bolash R, Kalasbail P, Drake RL, Elkassabany N. Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation. Reg Anesth Pain Med. 2018 Oct;43(7):745-751. doi: 10.1097/AAP.0000000000000824.
- Background: PubMed 28149550Hsieh MJ, Wang KC, Liu HP, Gonzalez-Rivas D, Wu CY, Liu YH, Wu YC, Chao YK, Wu CF. Management of acute postoperative pain with continuous intercostal nerve block after single port video-assisted thoracoscopic anatomic resection. J Thorac Dis. 2016 Dec;8(12):3563-3571. doi: 10.21037/jtd.2016.12.30.
- Individual participant dataSharing planned: Yes. The data sets used in this research may be made available upon reasonable request to the corresponding author.
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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 ESP block group and RISS block group in people with Video Assisted Thoracoscopic Surgery and Regional Block for Pain Control, run by Bursa City 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 5 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: finished, as of the sponsor's last update on 24 Sep 2026. 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?
Incidence of chest tube-site somatic pain (time frame: At postoperative hour 2). 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 NCT07011069, 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 24 Sep 2026.