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

June 12, 2023 updated by: Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

456

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain score（NRS）
Time Frame: 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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in postoperative pain
Time Frame: 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.
Day 2
the use of flurbiprofen axetil
Time Frame: Day 3
the amount of rescue analgesic drugs flurbiprofen axetil used
Day 3
the use of dolantin
Time Frame: Day 3
the amount of rescue analgesic drugs dolantin used
Day 3
the use of opioids
Time Frame: Day 2
total amount of opioid use within 48h after surgery
Day 2
postoperative adverse events
Time Frame: Day 3
the incidence of nausea, vomiting, and vertigo after surgery
Day 3
the amount of postoperative wound drainage
Time Frame: Day 3
total amount of fluid drained after surgery
Day 3
C-reactive protein
Time Frame: Day 1
The inflammatory marker of participants will be test after surgery
Day 1
interleukin-6
Time Frame: Day 1
The inflammatory marker of participants will be test after surgery
Day 1
postoperative delusion
Time Frame: Day 3
The incidence of postoperative delusion.
Day 3
drainage extraction
Time Frame: up to 24 hours (before extubation)
The time taken for the patient to remove the drain after surgery
up to 24 hours (before extubation)
ICU stay time
Time Frame: 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.
From date of ICU admission until the date of leaving ICU, assessed up to 5 days.
postoperative pulmonary complications
Time Frame: Day 3
The probability of patients acquiring pulmonary complications after surgery.
Day 3
hospital length of stay
Time Frame: From date of hospital admission until the date of discharge,assessed up to 15 days.
The time between hospital admission and discharge
From date of hospital admission until the date of discharge,assessed up to 15 days.
healing rate of drainage wound
Time Frame: Day 21
The healing rate of drainage wound at 21 days after surgery.
Day 21
readmission rate
Time Frame: Month 1
The readmission rate of patients in one month after surgery.
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

June 1, 2023

Study Completion (Estimated)

June 1, 2023

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202210-071-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on Lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe