The Impact of Intrapleural Block on Postoperative Pain Caused by Drainage Tubes After Thoracoscopic Surgery

NCT ID: NCT07294755

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2027-01-01

Brief 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". 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.

Conditions

Postoperative Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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.

Intervention Group 1

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.

Group Type: EXPERIMENTAL

Investigational drug 20 mL of 0.5% ropivacaine

Intervention Type: DRUG

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.

Intervention Group 2

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.

Group Type: EXPERIMENTAL

0.5% ropivacaine + 25 mg tetracaine, made up to a total volume of 20 mL

Intervention Type: DRUG

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.

Interventions

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 normal saline via intrapleural instillation.

Intervention Type: 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 ① via intrapleural instillation.

Intervention Type: 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 either Investigational Drug ② via intrapleural instillation.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jingsheng Lou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

301YXM01

Identifier Type: -

Identifier Source: org_study_id