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

Shandong University

Status: Not yet enrolling

Conditions: Lidocaine; Pain, Postoperative; Analgesia; Thoracic Surgery

Treatments: Drug: normal saline; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05901389

KYLL-202210-071-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 456 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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456 participants in 2 patient groups, including a placebo group

lidocaine

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine

normal saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: normal saline