Lobectomy
Conditions
Brief summary
Combining tegileridine PCIA with ICNB targeting peripheral nerves, may constitute an ideal analgesic model with complementary advantages. Thus potentially achieving the analgesic goal of "early pain relief, stable throughout the process, and rapid recovery," and may have a positive impact on reducing CPSP.
Detailed description
Combining tegileridine PCIA with ICNB targeting peripheral nerves, may constitute an ideal analgesic model with complementary advantages. ICNB provides rapid and precise incision analgesia in the early postoperative period, effectively blocking the transmission of peripheral nociceptive stimuli to the central nervous system. Tizanidine PCIA, on the other hand, enhances the function of the endogenous descending pain suppression system through its central G protein pathway activation, covering the pain period after the effect of ICNB wears off and components such as visceral referred pain. At the same time, it can effectively reduce side effects such as respiratory depression and nausea/vomiting, thus potentially achieving the analgesic goal of "early pain relief, stable throughout the process, and rapid recovery," and may have a positive impact on reducing CPSP.
Interventions
DRUGTegileridine
Administer 0.015 mg/kg (maximum 1mg) of tegileridine intravenously 40 minutes before the end of surgery, followed by the connection of a tegileridine patient-controlled intravenous analgesia (PCIA)
PROCEDUREIntercostal Nerve Block
Before closing the chest, the thoracic surgeon injected 3mL of 0.4% ropivacaine into the 4th, 5th, and 6th intercostal spaces through thoracoscopy for intercostal nerve block.
DRUGSufentanil
Administer 0.15 μg/kg (maximum 10 μg) of sufentanil intravenously 40 minutes before the end of surgery, followed by the connection of a sufentanil patient-controlled intravenous analgesia (PCIA)
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age range: 18 to 75 years old; * Patients undergoing elective thoracoscopic lobectomy or segmentectomy; * ASA classification levels I-III; * BMI 18 \~ 30 kg/m2。 * Voluntarily participate and sign an informed consent form.
Exclusion criteria
* Patients with preoperative alcohol dependence and long-term use of analgesic drugs are receiving analgesic treatment for other acute and chronic pain; * Pregnant or lactating women; * Allergies or other contraindications to the anesthetics, analgesics, and antiemetic drugs used in the study; * Patients with severe sleep apnea syndrome or acute or severe bronchial asthma; * Suffering from mental and neurological disorders or cognitive impairment, known or suspected gastrointestinal obstruction, severe liver and kidney dysfunction (Child Pugh score C), chronic obstructive pulmonary disease or severe cardiovascular disease, etc; * Researchers consider participants who are not suitable to participate in this study and those who refuse to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS (Visual Analog Scale) pain score | 48 hours | VAS pain score 0-10, the higher scores mean a worse outcome; Analgesic effect assessed during activity in the post-anesthesia care unit (PACU) and at 1, 6, 12, 24, 36, and 48 hours post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| doses of remedial analgesic drugs | 48hours | The total consumption of remedial analgesic drugs within 48 hours post-surgery |
| PCIA-related parameters | 48 hours | Including total analgesic consumption, number of effective presses, and total number of presses |
| Incidence of opioid-related adverse events (ORAEs) | 48 hours | Including Respiratory depression (defined as respiratory rate \< 8 breaths/min or SpO₂ \< 90%); ② Postoperative nausea and vomiting (PONV); ③ Pruritus; ④ Dizziness; ⑤ Delayed recovery of gastrointestinal function, etc. |
| The length of postoperative hospital stay | 10 days | The length of postoperative hospital stay from the end of surgery to hospital discharge |
| The quality of sleep | 10 days | AIS sleep scale was used to assess the quality of sleep |
Contacts
CONTACTAijun Xu, Dr.
CONTACTHongbo Zheng, Dr.
STUDY_CHAIRaihua Du, Dr.
Tongji Hospital
Outcome results
None listed