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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05901389
• Other study ID #: KYLL-202210-071-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: June 2023

Study information

• Verified date: January 2023
• Source: Qilu Hospital of Shandong University
• Contact: Jinying Zhang
• Phone: 18560087707
• Email: zhjydzx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 456
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Lidocaine
• Pain, Postoperative
• Thoracic Surgery

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

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