Health TrialsbyHealthPanel

Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection

ConditionLobectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age range: 18 to 75 years old;

Patients undergoing elective thoracoscopic lobectomy or segmentectomy;

ASA classification levels I-III;

BMI 18 ~ 30 kg/m2。

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tegileridine

    Drug

    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)

  • Intercostal Nerve Block

    Procedure/Surgery

    Before closing the chest, the thoracic surgeon injected 3mL of 0.4% ropivacaine into the 4th, 5th, 6th and 7th intercostal spaces through thoracoscopy for intercostal nerve block.

  • Sufentanil

    Drug

    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)

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: sufentanil groupActive comparator 2 interventions
Group B: Tegileridine groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

VAS (Visual Analog Scale) pain score

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

Time frame
48 hours

Secondary outcomes

1

total dosage of remedial analgesic drugs

The total consumption of remedial analgesic drugs within 48 hours post-surgery

Time frame
48hours
2

PCIA-related parameters

Including total analgesic consumption, number of effective presses, and total number of presses

Time frame
48 hours
3

Incidence of opioid-related adverse events (ORAEs)

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.

Time frame
48 hours
4

The length of postoperative hospital stay

The length of postoperative hospital stay from the end of surgery to hospital discharge

Time frame
10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov
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