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

NCT05901389 | Unknown

• 1 other identifier: KYLL-202210-071-1
• Study Type: interventional
• Target: 456
• Locations: 0 countries
• Sites: N/A

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 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. In this study,the investigators mainly investigated the incidence of postoperative pain score was greater than 3 in each group.

  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

EXPERIMENTAL

Patients in this group will receive continuous lidocaine infusion via closed chest drainage tube. The pulse infusion speed is 1ml / 30min, and the continuous infusion speed was 2ml / h.

Drug: Lidocaine

normal saline

PLACEBO COMPARATOR

Patients in this group will receive continuous normal saline infusion via closed chest drainage tube. The pulse infusion speed is same as the lidocaine group.

Drug: normal saline

Interventions

Lidocaine DRUG

After the thoracoscopic surgery, lidocaine will be transfused through the epidural tube fixed in the chest drainage tube was connected to an electronic pump whose parameters are already set up (marking the chest drain for analgesia).

lidocaine

normal saline DRUG

After the thoracoscopic surgery, normal saline will be transfused through the epidural tube fixed in the chest drainage tube was connected to an electronic pump whose parameters are already set up (marking the chest drain for analgesia).

normal saline

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

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MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Lidocaine; Saline Solution

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Jinying Zhang

CONTACT

18560087707; zhjydzx@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-01