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

NCT05901389 | Completed

• 1 other identifier: KYLL-202210-071-1
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lidocaine; Analgesia; Pain, Postoperative; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• postoperative pain score（NRS）

  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).

  Day 1

Secondary Outcomes (15)

• Changes in postoperative pain

  Day 2

• the use of flurbiprofen axetil

  Day 3

• the use of dolantin

  Day 3

• the use of opioids

  Day 2

• postoperative adverse events

  Day 3

Study Arms (2)

Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA

EXPERIMENTAL

Patients receive continuous intrapleural lidocaine infusion via the closed chest drainage tube (pulse 1 mL/30 min + continuous 2 mL/h) combined with reduced-dose sufentanil patient-controlled intravenous analgesia (PCIA, 1.0-1.5 µg/kg for 48 h).

Drug: Lidocaine; Drug: Sufentanil

Standard-dose sufentanil PCIA

ACTIVE COMPARATOR

Patients receive standard-dose sufentanil PCIA (2.0-2.5 µg/kg for 48 h) alone.

Drug: Sufentanil

Interventions

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).

Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA

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.

Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA; Standard-dose sufentanil PCIA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, China

Location

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MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Lidocaine; Sufentanil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is open-label (unblinded). Because the IPCIL group required an additional intrapleural infusion pump that was not present in the control group, blinding of both participants and investigators was not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the attending doctor

Model Details: lidocaine will be injection by electronic analgesic pump, and the pulse infusion speed is 1ml / 30min, and 2ml / h for continuous infusion

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 13, 2023
• Study Start: June 7, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 30, 2023
• Last Updated: September 24, 2026

Record last verified: 2023-07

Locations

CN (1)