Continuous Lidocaine Infusion Via Closed Chest Drainage Tube for Pain Control After Thoracoscopic Partial Lung Resection
- Conditions
- LidocainePain, PostoperativeThoracic SurgeryAnalgesia
- Interventions
- Drug: normal saline
- Registration Number
- NCT05901389
- Lead Sponsor
- Qilu Hospital of Shandong University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 456
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description normal saline 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. lidocaine 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method C-reactive protein Day 1 The inflammatory marker of participants will be test after surgery
the use of dolantin Day 3 the amount of rescue analgesic drugs dolantin used
readmission rate Month 1 The readmission rate of patients in one month 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.
the use of opioids Day 2 total amount of opioid use within 48h after surgery
the amount of postoperative wound drainage Day 3 total amount of fluid drained after surgery
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.
healing rate of drainage wound Day 21 The healing rate of drainage wound at 21 days after surgery.
postoperative adverse events Day 3 the incidence of nausea, vomiting, and vertigo after surgery
postoperative pulmonary complications Day 3 The probability of patients acquiring pulmonary complications after surgery.
the use of flurbiprofen axetil Day 3 the amount of rescue analgesic drugs flurbiprofen axetil used
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.
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