Video Assisted Thoracoscopic SurgerySERRATHORNCT03867695
SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy
A study testing Ropivacaine and sterile saline in people with Video Assisted Thoracoscopic Surgery and Lobectomy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Video Assisted Thoracoscopic Surgery, Lobectomy, Pain Post Operative
- What is being tested?
- Ropivacaine and sterile saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2019to 30 Oct 2020
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing lobectomy VATS
- Older > 18 years
- Patients who meet criteria of ASA 1 to 3 class
Who cannot join
- Patient's refusal to participate in the study
- Psychiatric disorder (impossibility to collect the informed consent)
- Patient under juridical protection
- On going an other study
- Non balanced epilepsy
- 3 grade auriculo-ventricular heart block without pacing
Show all 11Show fewer
- Severe hepatocellular insufficiency
- Anti arrhythmic treatment : class III of the Vaughan William's classification
- Pregnant patient or/and breastfeeding
- History of opioid abuse
- Allergy to local anesthetic drug or opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy
Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS.
Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine.
The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.
- Being tested
- Ropivacaine, sterile saline
- Keywords
- Serratus plane block, Analgesia after VATS, Lobectomy VATS
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.
sterile salineDrug
Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution
| Study group | Role | What they receive |
|---|---|---|
| Serratus Block | Experimental | At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.
Under ultrasonography assistance, block will be performed at the fifth rib in the midaxillary line. Local anesthetic will be injected either superficial to the serratus anterior muscle or deep underneath the muscle.
Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product. Receives: Drug: Ropivacaine |
| Placebo Block - Control Group | Placebo comparator | Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution. Under ultrasonography assistance, placebo will be injected at the fifth rib in the midaxillary line, either superficial to the serratus anterior muscle or deep underneath the muscle.
Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of sterile saline will be prepared identically by the central pharmacy, without any possible identification of the product. Receives: Drug: sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intravenous morphine consumption (mg) in the PACU and department.
Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start3 Sep 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Why it stopped: The early termination of this study is justified by changes in the recommendations. Specifically, a paravertebral block-that is, a regional anesthesia technique-is now recommended. Consequently, subject recruitment has been halted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Assisted Thoracoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bob HEGER, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867695
- Sponsor's protocol ID
- 6755
- Acronym
- SERRATHOR
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2019
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy
- ClinicalTrials.gov ID
- NCT03867695
- Acronym / sponsor ID
- SERRATHOR / 6755
- Keywords
- Serratus plane block, Analgesia after VATS, Lobectomy VATS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The early termination of this study is justified by changes in the recommendations. Specifically, a paravertebral block-that is, a regional anesthesia technique-is now recommended. Consequently, subject recruitment has been halted.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 8 Mar 2019 (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.
Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS.
Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine.
The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Block | Experimental | Drug: RopivacaineAt the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered. Under ultrasonography assistance, block will be performed at the fifth rib in the midaxillary line. Local anesthetic will be injected either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product. |
| Placebo Block - Control Group | Placebo comparator | Drug: sterile salinePatients will receive a placebo injection with 0,5 mL/kg of sterile normal solution. Under ultrasonography assistance, placebo will be injected at the fifth rib in the midaxillary line, either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of sterile saline will be prepared identically by the central pharmacy, without any possible identification of the product. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing lobectomy VATS
- Older > 18 years
- Patients who meet criteria of ASA 1 to 3 class
Key exclusion criteria (11 listed)
- Patient's refusal to participate in the study
- Psychiatric disorder (impossibility to collect the informed consent)
- Patient under juridical protection
- On going an other study
- Non balanced epilepsy
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 |
|---|---|---|
| RopivacaineAt the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered. | Drug | Serratus Block |
| sterile salinePatients will receive a placebo injection with 0,5 mL/kg of sterile normal solution | Drug | Placebo Block - Control Group |
Primary outcome
Total intravenous morphine consumption (mg) in the PACU and department.
Time frame: 24 hours
Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively.
Results and safety
The study was stopped early (reason given: The early termination of this study is justified by changes in the recommendations. Specifically, a paravertebral block-that is, a regional anesthesia technique-is now recommended. Consequently, subject recruitment has been halted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Video Assisted Thoracoscopic Surgery
Recruiting
ITPB 1 vs 3 in VATS
Musculoskeletal Diseases or Conditions
Not yet recruiting
TBLC vs NIVATS in Interstitial Lung Disease
Interstitial Lung Diseases (ILD)
Not yet recruiting
Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection
Thoracic Neoplasms
Recruiting
Comparison of the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS Ngoerah
Pain, Postoperative Pain
Not yet recruitingObservational study
Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
One-lung Ventilation (OLV), Video-assisted Thoracis Surgery (VATS)
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.
Bob HEGER principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine and sterile saline in people with Video Assisted Thoracoscopic Surgery and Lobectomy, run by University Hospital, Strasbourg, France at 1 site in France.
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 11 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: stopped early, as of the sponsor's last update on 10 Jul 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 France. 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 was stopped early (reason given: The early termination of this study is justified by changes in the recommendations. Specifically, a paravertebral block-that is, a regional anesthesia technique-is now recommended. Consequently, subject recruitment has been halted.). Results are not available in the source record.
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?
Total intravenous morphine consumption (mg) in the PACU and department. (time frame: 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 10 Jul 2026.