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

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05901389

Collaborator

(none)

456

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lidocaine Analgesia Pain, Postoperative Thoracic Surgery	Drug: Lidocaine Drug: normal saline	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

456 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official 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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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).
Placebo Comparator: 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.	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).

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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).

Placebo Comparator: 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.

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).

Outcome Measures

Primary Outcome Measures

postoperative pain score（NRS） [Day 1]
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.

Secondary Outcome Measures

Changes in postoperative pain [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.
the use of flurbiprofen axetil [Day 3]
the amount of rescue analgesic drugs flurbiprofen axetil used
the use of dolantin [Day 3]
the amount of rescue analgesic drugs dolantin used
the use of opioids [Day 2]
total amount of opioid use within 48h after surgery
postoperative adverse events [Day 3]
the incidence of nausea, vomiting, and vertigo after surgery
the amount of postoperative wound drainage [Day 3]
total amount of fluid drained after surgery
C-reactive protein [Day 1]
The inflammatory marker of participants will be test after surgery
interleukin-6 [Day 1]
The inflammatory marker of participants will be test after surgery
postoperative delusion [Day 3]
The incidence of postoperative delusion.
drainage extraction [up to 24 hours (before extubation)]
The time taken for the patient to remove the drain after surgery
ICU stay time [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.
postoperative pulmonary complications [Day 3]
The probability of patients acquiring pulmonary complications after surgery.
hospital length of stay [From date of hospital admission until the date of discharge,assessed up to 15 days.]
The time between hospital admission and discharge
healing rate of drainage wound [Day 21]
The healing rate of drainage wound at 21 days after surgery.
readmission rate [Month 1]
The readmission rate of patients in one month after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Qilu Hospital of Shandong University

ClinicalTrials.gov Identifier:

NCT05901389

Other Study ID Numbers:

KYLL-202210-071-1

First Posted:

Jun 13, 2023

Last Update Posted:

Jun 13, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Lidocaine

Study Results

No Results Posted as of Jun 13, 2023