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

NCT ID: NCT05901389

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lidocaine Analgesia Pain, Postoperative Thoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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lidocaine

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.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type 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).

normal saline

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.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type 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).

Interventions

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Lidocaine

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).

Intervention Type DRUG

normal saline

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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jinying Zhang

Role: CONTACT

18560087707

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Other Identifiers

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KYLL-202210-071-1

Identifier Type: -

Identifier Source: org_study_id

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