Postoperative AnalgesiaNCT07294755
The Impact of Intrapleural Block on Postoperative Pain Caused by Drainage Tubes After Thoracoscopic Surgery
A study testing normal saline, Investigational drug 20 mL of 0.5% ropivacaine and 0.5% ropivacaine + 25 mg tetracaine, made up to a total volume of 20 mL in people with Postoperative Analgesia, run by Chinese PLA General Hospital.
Trial summary
the investigators hereby invite participants to participate in a study entitled "The Impact of Intrapleural Block via Thoracoscopic Surgery on Postoperative Pain Caused by Drainage Tubes". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- normal saline, Investigational drug 20 mL of 0.5% ropivacaine and 0.5% ropivacaine + 25 mg tetracaine, made up to a total volume of 20 mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years old;
- American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅲ, and patients undergoing pulmonary resection via video-assisted thoracic surgery (VATS) under general anesthesia;
- Voluntarily signing the informed consent form;(4) Body Mass Index (BMI) ranging from 18 to 25 kg/m².
Who cannot join
- Patients with American Society of Anesthesiologists (ASA) physical status classification >Ⅲ;
- Patients allergic to amide-type local anesthetics;
- Patients with recent intrathoracic infection;
- Patients with a history of previous pulmonary surgery;
- Patients with long-term alcohol abuse or chronic use of sedatives and analgesics;
- Patients with severe hepatic or renal insufficiency;
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- Patients refusing to participate in the study;
- Patients unable to complete the Numeric Rating Scale (NRS);
- Patients expected to be admitted to the Intensive Care Unit (ICU) postoperatively;
- Patients with a Mini-Mental State Examination (MMSE) score <18;
- Pregnant or lactating women;
- Patients with a history of chronic pain;
- Patients not requiring indwelling closed thoracic drainage tube postoperatively;
- Patients converted from video-assisted thoracic surgery (VATS) to thoracotomy intraoperatively.
About this study
the investigators hereby invite participants to participate in a study entitled "The Impact of Intrapleural Block via Thoracoscopic Surgery on Postoperative Pain Caused by Drainage Tubes". This study is an extension of hospital's major clinical research project: "Efficacy and Safety of Perioperative Intrapleural Block with Local Anesthetics for Acute Postoperative Pain in Adult Thoracic and Pulmonary Surgery: A Prospective, Multicenter, Randomized, Open-Label, Positive Parallel-Controlled, Pragmatic Clinical Trial".During breathing and position changes, the postoperative closed thoracic drainage tube continuously rubs against the pleura, causing severe acute pain in patients. This study hypothesizes that analgesia via a single postoperative spray of local anesthetics into the pleural space is effective, and aims pleural space is effective, and aims to investigate whether a single spray of different local anesthetics can alleviate early acute pain caused by postoperative closed thoracic drainage.
This is a pragmatic randomized controlled study. participants have a 1/3 chance of being randomly assigned to Trial Group A, a 1/3 chance to Trial Group B, and a 1/3 chance to the Control Group. If assigned to Trial Group A, participants will receive an intrapleural block with ropivacaine hydrochloride injection; if assigned to Trial Group B, the intrapleural block will contain both ropivacaine hydrochloride injection and tetracaine hydrochloride injection; if assigned to the Control Group, participants will undergo an intrapleural block without any active medications. All three intrapleural block regimens are fully compatible with the overall disease diagnosis and treatment plan and will not exert any differential impact on participants' subsequent treatment. Additionally, participants' other medical procedures and related costs will not be affected in any way.
Read more
Before surgery, as well as at 2, 4, 6, 8, 24, 48 and72 hours after surgery, physicians will conduct follow-up assessments. Participants will also need to complete corresponding follow-up questionnaires under the guidance of doctors. These assessments and questionnaires aim to comprehensively evaluate the analgesic efficacy of the medications, the incidence of postoperative depression, anxiety, cognitive impairment, sleep disturbances, delirium, and adverse reactions, while collecting relevant data. No additional fees will be charged for this process.
Participation in this study is entirely voluntary. Participants may refuse to participate or withdraw from the study at any time during the process without providing any reason. This decision will not affect participants' future medical treatment.
If participants decide to withdraw from the study, please notify participants' research physician in advance. To ensure participants' safety, participants may be required to undergo relevant examinations, which are beneficial for protecting participants' health.
If participants decide to participate in this study, participants' participation and personal data collected during the study will be kept strictly confidential. Physicians in charge of the study and other researchers will use participants' medical information for research purposes only. Participants medical records will be accessible exclusively to the research team. Participants identity will remain anonymous, and only the research physicians and members of the research team will have access to participants' assigned study ID.
- Conditions
- Postoperative Analgesia
- Being tested
- normal saline, Investigational drug 20 mL of 0.5% ropivacaine, 0.5% ropivacaine + 25 mg tetracaine, made up to a total volume of 20 mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
Subjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received normal saline via intrapleural instillation.
Investigational drug 20 mL of 0.5% ropivacaineDrug
Subjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received either Investigational Drug ① via intrapleural instillation.
0.5% ropivacaine + 25 mg tetracaine, made up to a total volume of 20 mLDrug
Subjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received either Investigational Drug ② via intrapleural instillation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Subjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received normal saline via intrapleural instillation. Receives: Drug: normal saline |
| Intervention Group 1 | Experimental | Subjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received either Investigational Drug ① via intrapleural instillation. Receives: Drug: Investigational drug 20 mL of 0.5% ropivacaine |
| Intervention Group 2 | Experimental | Subjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received either Investigational Drug ② via intrapleural instillation. Receives: Drug: 0.5% ropivacaine + 25 mg tetracaine, made up to a total volume of 20 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) scores for resting, movement, and coughing
Numeric Rating Scale (NRS) scores for resting, movement, and coughing at the following time points: immediately after postoperative awakening, 30 minutes after surgery , 2 hours, 4 hours, 6 hours, 8 hours, 1 day ; 2 day ; 3 day . The lower the pain score, the greater the patient benefit.
Measured: immediately after postoperative awakening； 30 minutes after surgery ； 2 hours after surgery ; 4 hours after surgery ; 6 hours after surgery ; 8 hours after surgery ; 1 day after surgery ; 2 day after surgery ; 3 day after surgery .
Secondary outcomes (3)
Athens insomnia scale
Sleep assessment on postoperative days 1-3: Athens Insomnia Scale (AIS) score. Total score range: 0-24.
- <4: no sleep disturbance
- 4-6: sleep disturbance
- >6: clinical insomnia
Measured: Baseline 1 day after surgery ; 2 day after surgery ; 3 day after surgery.
The duration of intrapleural analgesia
Duration of intrapleural analgesia: the interval from full emergence (first postoperative C-NRS) until the moment C-NRS ≥ 4 or an increase of ≥ 2 points.
If the initial C-NRS is already ≥ 4, rescue analgesia is administered and the block is considered ineffective.
Measured: Within 3 days after surgery; before chest tube removal.
Hospital Anxiety and Depression Scale (HADS) scores
Hospital Anxiety and Depression Scale (HADS) scores pre-operatively and on postoperative days 1-3
Measured: Baselineand postoperative day 1; postoperative day 2; postoperative day 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start20 Apr 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingsheng Lou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294755
- Sponsor's protocol ID
- 301YXM01
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intrapleural Block on Postoperative Pain Caused by Drainage Tubes After Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT07294755
- Acronym / sponsor ID
- 301YXM01
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 Dec 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.
the investigators hereby invite participants to participate in a study entitled "The Impact of Intrapleural Block via Thoracoscopic Surgery on Postoperative Pain Caused by Drainage Tubes". This study is an extension of hospital's major clinical research project: "Efficacy and Safety of Perioperative Intrapleural Block with Local Anesthetics for Acute Postoperative Pain in Adult Thoracic and Pulmonary Surgery: A Prospective, Multicenter, Randomized, Open-Label, Positive Parallel-Controlled, Pragmatic Clinical Trial".During breathing and position changes, the postoperative closed thoracic drainage tube continuously rubs against the pleura, causing severe acute pain in patients. This study hypothesizes that analgesia via a single postoperative spray of local anesthetics into the pleural space is effective, and aims pleural space is effective, and aims to investigate whether a single spray of different local anesthetics can alleviate early acute pain caused by postoperative closed thoracic drainage.
This is a pragmatic randomized controlled study. participants have a 1/3 chance of being randomly assigned to Trial Group A, a 1/3 chance to Trial Group B, and a 1/3 chance to the Control Group. If assigned to Trial Group A, participants will receive an intrapleural block with ropivacaine hydrochloride injection; if assigned to Trial Group B, the intrapleural block will contain both ropivacaine hydrochloride injection and tetracaine hydrochloride injection; if assigned to the Control Group, participants will undergo an intrapleural block without any active medications. All three intrapleural block regimens are fully compatible with the overall disease diagnosis and treatment plan and will not exert any differential impact on participants' subsequent treatment. Additionally, participants' other medical procedures and related costs will not be affected in any way.
Before surgery, as well as at 2, 4, 6, 8, 24, 48 and72 hours after surgery, physicians will conduct follow-up assessments. Participants will also need to complete corresponding follow-up questionnaires under the guidance of doctors. These assessments and questionnaires aim to comprehensively evaluate the analgesic efficacy of the medications, the incidence of postoperative depression, anxiety, cognitive impairment, sleep disturbances, delirium, and adverse reactions, while collecting relevant data. No additional fees will be charged for this process.
Participation in this study is entirely voluntary. Participants may refuse to participate or withdraw from the study at any time during the process without providing any reason. This decision will not affect participants' future medical treatment.
If participants decide to withdraw from the study, please notify participants' research physician in advance. To ensure participants' safety, participants may be required to undergo relevant examinations, which are beneficial for protecting participants' health.
If participants decide to participate in this study, participants' participation and personal data collected during the study will be kept strictly confidential. Physicians in charge of the study and other researchers will use participants' medical information for research purposes only. Participants medical records will be accessible exclusively to the research team. Participants identity will remain anonymous, and only the research physicians and members of the research team will have access to participants' assigned study ID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: normal salineSubjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received normal saline via intrapleural instillation. |
| Intervention Group 1 | Experimental | Drug: Investigational drug 20 mL of 0.5% ropivacaineSubjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received either Investigational Drug ① via intrapleural instillation. |
| Intervention Group 2 | Experimental | Drug: 0.5% ropivacaine + 25 mg tetracaine, made up to a total volume of 20 mLSubjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received either Investigational Drug ② via intrapleural instillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old;
- American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅲ, and patients undergoing pulmonary resection via video-assisted thoracic surgery (VATS) under general anesthesia;
- Voluntarily signing the informed consent form;(4) Body Mass Index (BMI) ranging from 18 to 25 kg/m².
Key exclusion criteria (14 listed)
- Patients with American Society of Anesthesiologists (ASA) physical status classification >Ⅲ;
- Patients allergic to amide-type local anesthetics;
- Patients with recent intrathoracic infection;
- Patients with a history of previous pulmonary surgery;
- Patients with long-term alcohol abuse or chronic use of sedatives and analgesics;
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 |
|---|---|---|
| normal salineSubjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received normal saline via intrapleural instillation. | Drug | Control group |
| Investigational drug 20 mL of 0.5% ropivacaineSubjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received either Investigational Drug ① via intrapleural instillation. | Drug | Intervention Group 1 |
| 0.5% ropivacaine + 25 mg tetracaine, made up to a total volume of 20 mLSubjects were randomly assigned in a 1:1:1 ratio within 0-24 hours prior to the initiation of elective surgery using computer-generated random numbers. After placement of the thoracic drainage tube, they received either Investigational Drug ② via intrapleural instillation. | Drug | Intervention Group 2 |
Primary outcome
Numeric Rating Scale (NRS) scores for resting, movement, and coughing
Time frame: immediately after postoperative awakening； 30 minutes after surgery ； 2 hours after surgery ; 4 hours after surgery ; 6 hours after surgery ; 8 hours after surgery ; 1 day after surgery ; 2 day after surgery ; 3 day after surgery .
Numeric Rating Scale (NRS) scores for resting, movement, and coughing at the following time points: immediately after postoperative awakening, 30 minutes after surgery , 2 hours, 4 hours, 6 hours, 8 hours, 1 day ; 2 day ; 3 day . The lower the pain score, the greater the patient benefit.
3 secondary outcomes
Athens insomnia scale
Time frame: Baseline 1 day after surgery ; 2 day after surgery ; 3 day after surgery.
The duration of intrapleural analgesia
Time frame: Within 3 days after surgery; before chest tube removal.
Hospital Anxiety and Depression Scale (HADS) scores
Time frame: Baselineand postoperative day 1; postoperative day 2; postoperative day 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline, Investigational drug 20 mL of 0.5% ropivacaine and 0.5% ropivacaine + 25 mg tetracaine, made up to a total volume of 20 mL in people with Postoperative Analgesia, run by Chinese PLA General Hospital.
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 14 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Numeric Rating Scale (NRS) scores for resting, movement, and coughing (time frame: immediately after postoperative awakening； 30 minutes after surgery ； 2 hours after surgery ; 4 hours after surgery ; 6 hours after surgery ; 8 hours after surgery ; 1 day after surgery ; 2 day after surgery ; 3 day after surgery .). 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 16 Mar 2026.