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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05901389
Enrollment
456
Registered
2023-06-13
Start date
2023-06-30
Completion date
2023-06-30
Last updated
2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Lidocaine, Pain, Postoperative, Thoracic Surgery

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.

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.

Interventions

DRUGLidocaine

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).

DRUGnormal 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).

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain score(NRS)Day 1The 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

MeasureTime frameDescription
the use of flurbiprofen axetilDay 3the amount of rescue analgesic drugs flurbiprofen axetil used
the use of dolantinDay 3the amount of rescue analgesic drugs dolantin used
the use of opioidsDay 2total amount of opioid use within 48h after surgery
postoperative adverse eventsDay 3the incidence of nausea, vomiting, and vertigo after surgery
the amount of postoperative wound drainageDay 3total amount of fluid drained after surgery
C-reactive proteinDay 1The inflammatory marker of participants will be test after surgery
interleukin-6Day 1The inflammatory marker of participants will be test after surgery
Changes in postoperative painDay 2Changes 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.
drainage extractionup to 24 hours (before extubation)The time taken for the patient to remove the drain after surgery
ICU stay timeFrom 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 complicationsDay 3The probability of patients acquiring pulmonary complications after surgery.
hospital length of stayFrom 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 woundDay 21The healing rate of drainage wound at 21 days after surgery.
readmission rateMonth 1The readmission rate of patients in one month after surgery.
postoperative delusionDay 3The incidence of postoperative delusion.

Contacts

Primary ContactJinying Zhang
zhjydzx@163.com18560087707

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026