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NCT Number: NCT05901389

Continuous Lidocaine Infusion Via Closed Chest Drainage Tube for Pain Control After Thoracoscopic Partial Lung Resection

The goal of this clinical trial is to learn about the effects on postoperative analgesia of continuous lidocaine infusion via closed chest drainage tube for patients undergoing thoracoscopic partial lung resection. The main questions it aims to answer are:

* To explore whether continuous lidocaine pumping via closed chest drainage tube has good analgesic and anti-inflammatory effects for patients undergoing partial thoracoscopic pneumonectomy. * Whether the multimodal analgesia combined with continuous lidocaine pump can reduce the postoperative application of opioids, reduce the occurrence of postoperative complications, and promote the recovery of postoperative lung function and accelerate recovery.

For participants who undergoing the thoracoscopic partial lung resection with postoperative indwelling drainage tube, the epidural tube fixed in the drainage tube is connected to the completed infusion pump (marking the chest drain for analgesia). The comparison group only accept the intravenous analgesia after surgery.

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Key information

Conditions

Lidocaine Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Thoracic Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital

Jinan, Shandong, China

About this study

At present, multimodal analgesia has been the most commonly used approaches for the treatment of postoperative pain of thoracic surgery, including steroidal anti-inflammatory drugs, administration of opioid, and local anesthesia.

The investigators found that continuous lidocaine analgesia with local anesthesia through thoracic closed drainage tube could improve postoperative pain caused by drainage tube retention, reduce postoperative pain score, and improve postoperative recovery of respiratory function in patients. In the protocol, lidocaine was continuously pumped with a superficial anesthetic effect on the pleura, while mucosal absorption was almost equivalent to intravenous infusion, so its systemic anti-inflammatory effect is also explored.

In the protocol，participants will be randomized in a 1:1 ratio to the control or experimental groups. The experimental group received a continuous infusion of lidocaineThe experimental group used 2% lidocaine 100ml, and the control group was the conventional treatment group. The control group received only standard intravenous analgesia。In addition to receiving simple intravenous analgesia, the experimental group also received continuous infusion of lidocaine in the pleural cavity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants ages 18-70 years.
  • participants undergoing thoracoscopic partial lung resection with an indwelling drainage tube after surgery.
  • American Society of Anesthesiologists classification (ASA)I-III.

Exclusion criteria

  • severe heart failure, cardiac arrhythmias,the New York Heart Association(NYHA) classification≥III.
  • hypersensitivity to lidocaine,History of local anesthetic poisoning.
  • severe renal or hepatic dysfunction.
  • body mass index (BMI)>35 kg m-2.
  • severe pleural adhesions.

Treatment and study plan

Lidocaine

Drug

Continuous intrapleural infusion via epidural tube fixed in the closed chest drainage tube, connected to an electronic analgesic pump (pulse 1 mL/30 min + continuous 2 mL/h).

Sufentanil

Drug

Patient-controlled intravenous analgesia (PCIA): reduced dose 1.0-1.5 µg/kg in the lidocaine arm, standard dose 2.0-2.5 µg/kg in the control arm, both for 48 h.

Primary outcomes

  1. postoperative pain score（NRS）

    Time frame: Day 1

    The primary outcome is the incidence of a numeric rating scale (NRS) pain score > 3 on coughing/movement at 24 hours postoperatively (movement-evoked pain only).

Secondary outcomes

  1. Changes in postoperative pain

    Time frame: Day 2

    Changes in postoperative pain score (NRS) at 12h and 48h until extubation. The full name of NRS score is Numerical Rating Scale. The minimum value of NRS score is 0 and the maximum value is 10. Patients can score themselves according to the pain level corresponding to the number, A score of 0 represents painless, 1-3 represents mild pain, 4-6 represents moderate pain and should be intervened, 7-10 represents severe pain and requires urgent treatment.

  2. the use of flurbiprofen axetil

    Time frame: Day 3

    the amount of rescue analgesic drugs flurbiprofen axetil used

  3. the use of dolantin

    Time frame: Day 3

    the amount of rescue analgesic drugs dolantin used

  4. the use of opioids

    Time frame: Day 2

    total amount of opioid use within 48h after surgery

  5. postoperative adverse events

    Time frame: Day 3

    the incidence of nausea, vomiting, and vertigo after surgery

  6. the amount of postoperative wound drainage

    Time frame: Day 3

    total amount of fluid drained after surgery

  7. C-reactive protein

    Time frame: Day 1

    The inflammatory marker of participants will be test after surgery

  8. interleukin-6

    Time frame: Day 1

    The inflammatory marker of participants will be test after surgery

  9. postoperative delusion

    Time frame: Day 3

    The incidence of postoperative delusion.

  10. drainage extraction

    Time frame: up to 24 hours (before extubation)

    The time taken for the patient to remove the drain after surgery

  11. ICU stay time

    Time frame: From date of ICU admission until the date of leaving ICU, assessed up to 5 days.

    The length of time the patient remains in the ICU.

  12. postoperative pulmonary complications

    Time frame: Day 3

    The probability of patients acquiring pulmonary complications after surgery.

  13. hospital length of stay

    Time frame: From date of hospital admission until the date of discharge,assessed up to 15 days.

    The time between hospital admission and discharge

  14. healing rate of drainage wound

    Time frame: Day 21

    The healing rate of drainage wound at 21 days after surgery.

  15. readmission rate

    Time frame: Month 1

    The readmission rate of patients in one month after surgery.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

Effects of Continuous Lidocaine Infusion Via Closed Chest Drainage Tube on Postoperative Analgesia for Patients Undergoing Thoracoscopic Partial Lung Resection: a Single-center Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2023
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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