Anesthesia, LocalPhase 3thoracoscopicNCT04222010
Serratus Plain Block Versus Paravertebral Block Versus Serratus Plain Block and Paravertebral Block for Postoperative Pain Following Thoracoscopic Surgery
A Phase 3 study testing Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL) in people with Anesthesia, Local and Pain, Postoperative, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Acute and chronic postoperative pain remains a major concern following thoracoscopic surgery. Firstly because pain constitutes a serious concern for patients after surgery, and secondarily because an ineffective control of pain may lead to postoperative morbidity, especially in lung cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Pain, Postoperative
- What is being tested?
- Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2020to 22 Feb 2023
- Phase
- Phase 3
- 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
- adult patient over18 years old
- without guardianship
- video-assisted thoracoscopic surgery with 3 trocars
- No cons-indications to loco-regional anesthesia (allergy, skin condition)
Who cannot join
- patient under 18 years old
- patient under guardianship
- pregnant
- rejection of consent
- rejection of loco-regional anesthesia
- chronic pain antecedents under morphine medication
- pain assessment impossible
Trial locations and contacts
1 site in 1 country.
About this study
Acute and chronic postoperative pain remains a major concern following thoracoscopic surgery. Firstly because pain constitutes a serious concern for patients after surgery, and secondarily because an ineffective control of pain may lead to postoperative morbidity, especially in lung cancer surgery.
To date, several procedures have been described but the best modality of locoregional analgesia for thoracoscopic surgery has not been assessed yet. The main objective of this study is to evaluate efficiency of several validated approaches for preoperative locoregional analgesia, comparing serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery.
To this end, the investigators will conduct an interventional prospective monocentric, double blind, compared and randomized study. Previously to thoracoscopic surgery, patients will be randomized in one of the three following arms: serratus plain block, paravertebral block or serratus plain block and paravertebral block combined.
- Conditions
- Anesthesia, Local, Pain, Postoperative
- Being tested
- loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL), Loco-regional anesthesia : paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL), Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL)
- Keywords
- Anesthesia, Local, Pain, Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)Drug
Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia
Loco-regional anesthesia : paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL)Drug
Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia.
Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL)Drug
Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| serratus loco-regional anesthesia | Experimental | patient who underwent thoracoscopic surgery will be assigned to serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL) Receives: Drug: loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL) |
| paravertebral bloc Loco-regional anesthesia | Experimental | patient who underwent thoracoscopic surgery will be assigned to paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL) Receives: Drug: Loco-regional anesthesia : paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL) |
| serratus and paravertebral bloc Loco-regional anesthesia | Experimental | patient who underwent thoracoscopic surgery will be assigned to serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL) Receives: Drug: Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual analog scale (VAS) score at coughing
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.
Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.
With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).
Measured: Immediately after following thoracoscopic surgery
Secondary outcomes (6)
Pain Visual analog scale (VAS) score at coughing
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.
Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.
With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).
Measured: H1 = one hour following thoracoscopic surgery
Pain Visual analog scale (VAS) score at coughing
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.
Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.
With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).
Measured: H3 = 3 hours following thoracoscopic surgery
Pain Visual analog scale (VAS) score at coughing
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.
Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.
With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).
Measured: H6 = 6 hours following thoracoscopic surgery
Pain Visual analog scale (VAS) score at coughing
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.
Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.
With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).
Measured: Day1 = one day following thoracoscopic surgery
Pain Visual analog scale (VAS) score at coughing
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.
Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.
With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).
Measured: Day2 = two days following thoracoscopic surgery
Pain Visual analog scale (VAS) score at coughing
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.
Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale.
With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).
Measured: Day3 = 3 days following thoracoscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start2 Jan 2020
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
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 Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Berna, Pr, Principal investigator, CHU AmiensEmmanuel Lorne, Pr, Principal investigator, CHU AmiensAlex Fourdrain, MD, Principal investigator, CHU AmiensFlorent Leviel, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222010
- Sponsor's protocol ID
- PI2019_843_0051
- Acronym
- thoracoscopic
- Status last verified
- Sep 2025
- First submitted
- 28 Nov 2019
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leviel F, Fourdrain A, Delatre F, De Dominicis F, Lefebvre T, Bar S, Alshatri HY, Lorne E, Georges O, Berna P, Dupont H, Meynier J, Abou-Arab O. S erratus anterior plane block alone, paravertebral block alone and their combination in video-assisted thoracoscopic surgery: the THORACOSOPIC double-blind, randomized trial. Eur J Cardiothorac Surg. 2024 Mar 29;65(4):ezae082. doi: 10.1093/ejcts/ezae082.
PubMed 38548664
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Plain Block Versus Paravertebral Block Versus Serratus Plain Block and Paravertebral Block for Postoperative Pain Following Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT04222010
- Acronym / sponsor ID
- thoracoscopic / PI2019_843_0051
- Conditions
- Anesthesia, Local, Pain, Postoperative
- Keywords
- Anesthesia, Local, Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 9 Jan 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.
Acute and chronic postoperative pain remains a major concern following thoracoscopic surgery. Firstly because pain constitutes a serious concern for patients after surgery, and secondarily because an ineffective control of pain may lead to postoperative morbidity, especially in lung cancer surgery.
To date, several procedures have been described but the best modality of locoregional analgesia for thoracoscopic surgery has not been assessed yet. The main objective of this study is to evaluate efficiency of several validated approaches for preoperative locoregional analgesia, comparing serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery.
To this end, the investigators will conduct an interventional prospective monocentric, double blind, compared and randomized study. Previously to thoracoscopic surgery, patients will be randomized in one of the three following arms: serratus plain block, paravertebral block or serratus plain block and paravertebral block combined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| serratus loco-regional anesthesia | Experimental | Drug: loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)patient who underwent thoracoscopic surgery will be assigned to serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL) |
| paravertebral bloc Loco-regional anesthesia | Experimental | Drug: Loco-regional anesthesia : paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL)patient who underwent thoracoscopic surgery will be assigned to paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL) |
| serratus and paravertebral bloc Loco-regional anesthesia | Experimental | Drug: Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL)patient who underwent thoracoscopic surgery will be assigned to serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patient over18 years old
- without guardianship
- video-assisted thoracoscopic surgery with 3 trocars
- No cons-indications to loco-regional anesthesia (allergy, skin condition)
Key exclusion criteria (7 listed)
- patient under 18 years old
- patient under guardianship
- pregnant
- rejection of consent
- rejection of loco-regional anesthesia
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 |
|---|---|---|
| loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia | Drug | serratus loco-regional anesthesia |
| Loco-regional anesthesia : paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL)Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia. | Drug | paravertebral bloc Loco-regional anesthesia |
| Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL)Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia. | Drug | serratus and paravertebral bloc Loco-regional anesthesia |
Primary outcome
Pain Visual analog scale (VAS) score at coughing
Time frame: Immediately after following thoracoscopic surgery
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain. Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale. With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).
6 secondary outcomes
Pain Visual analog scale (VAS) score at coughing
Time frame: H1 = one hour following thoracoscopic surgery
Pain Visual analog scale (VAS) score at coughing
Time frame: H3 = 3 hours following thoracoscopic surgery
Pain Visual analog scale (VAS) score at coughing
Time frame: H6 = 6 hours following thoracoscopic surgery
Pain Visual analog scale (VAS) score at coughing
Time frame: Day1 = one day following thoracoscopic surgery
Pain Visual analog scale (VAS) score at coughing
Time frame: Day2 = two days following thoracoscopic surgery
Pain Visual analog scale (VAS) score at coughing
Time frame: Day3 = 3 days following thoracoscopic surgery
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 19 Sep 2025.
- Results publication: PubMed 38548664Leviel F, Fourdrain A, Delatre F, De Dominicis F, Lefebvre T, Bar S, Alshatri HY, Lorne E, Georges O, Berna P, Dupont H, Meynier J, Abou-Arab O. S erratus anterior plane block alone, paravertebral block alone and their combination in video-assisted thoracoscopic surgery: the THORACOSOPIC double-blind, randomized trial. Eur J Cardiothorac Surg. 2024 Mar 29;65(4):ezae082. doi: 10.1093/ejcts/ezae082.
- 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.
Pascal Berna, Pr principal investigator
CHU Amiens
Emmanuel Lorne, Pr principal investigator
CHU Amiens
Alex Fourdrain, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL) in people with Anesthesia, Local and Pain, Postoperative, run by Centre Hospitalier Universitaire, Amiens 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 4 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 19 Sep 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Visual analog scale (VAS) score at coughing (time frame: Immediately after following thoracoscopic surgery). 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 NCT04222010, 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 19 Sep 2025.