An interventional study of normal saline and Investigational drug 20 mL of 0.5% ropivacaine in Postoperative Analgesia, sponsored by Chinese PLA General Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment
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.
Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
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Exclusion Criteria:
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.
Drug: normal saline
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.
Drug: Investigational drug 20 mL of 0.5% ropivacaine
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.
Drug: 0.5% ropivacaine + 25 mg tetracaine, made up to a total volume of 20 mL
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.
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.
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.
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.
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 .
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
Time frame: 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.
Time frame: 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
Time frame: Baselineand postoperative day 1; postoperative day 2; postoperative day 3.
Document drug-related adverse events on postoperative
Document drug-related adverse events on postoperative days 1-3: emergence agitation/delirium, nausea and vomiting, dizziness, respiratory depression, number of rescue analgesia requests, pruritus, disorientation, etc.
Time frame: postoperative day 1 ; postoperative day 2 ; postoperative day 3.
Number of PICA demand attempts before chest-drain removal.
Number of IV-PCA demand attempts before chest-drain removal.
Time frame: Within 3 days after surgery; before chest tube removal.
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Chinese PLA General Hospital