Continue lidocaïne-infusie via gesloten thoraxdrainagebuis voor pijnbestrijding na thoracoscopische gedeeltelijke longresectie
Effecten van continue lidocaïne-infusie via gesloten thoraxdrainagebuis op postoperatieve analgesie voor patiënten die een thoracoscopische partiële longresectie ondergaan: een gerandomiseerde, gecontroleerde klinische studie in één centrum
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Shandong
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Jinan, Shandong, China
- Qilu Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA
Patients receive continuous intrapleural lidocaine infusion via the closed chest drainage tube (pulse 1 mL/30 min + continuous 2 mL/h) combined with reduced-dose sufentanil patient-controlled intravenous analgesia (PCIA, 1.0-1.5 µg/kg for 48 h). |
Continuous intrapleural infusion via epidural tube fixed in the closed chest drainage tube, connected to an electronic analgesic pump (pulse 1 mL/30 min + continuous 2 mL/h). Patient-controlled intravenous analgesia (PCIA): reduced dose 1.0-1.5 µg/kg in the lidocaine arm, standard dose 2.0-2.5 µg/kg in the control arm, both for 48 h. |
|
Actieve vergelijker: Standard-dose sufentanil PCIA
Patients receive standard-dose sufentanil PCIA (2.0-2.5 µg/kg for 48 h) alone. |
Patient-controlled intravenous analgesia (PCIA): reduced dose 1.0-1.5 µg/kg in the lidocaine arm, standard dose 2.0-2.5 µg/kg in the control arm, both for 48 h. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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postoperative pain score（NRS）
Tijdsspanne: Day 1
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The primary outcome is the incidence of a numeric rating scale (NRS) pain score > 3 on coughing/movement at 24 hours postoperatively (movement-evoked pain only). |
Day 1
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in postoperative pain
Tijdsspanne: 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
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the use of flurbiprofen axetil
Tijdsspanne: Day 3
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the amount of rescue analgesic drugs flurbiprofen axetil used |
Day 3
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the use of dolantin
Tijdsspanne: Day 3
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the amount of rescue analgesic drugs dolantin used |
Day 3
|
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the use of opioids
Tijdsspanne: Day 2
|
total amount of opioid use within 48h after surgery |
Day 2
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postoperative adverse events
Tijdsspanne: Day 3
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the incidence of nausea, vomiting, and vertigo after surgery |
Day 3
|
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the amount of postoperative wound drainage
Tijdsspanne: Day 3
|
total amount of fluid drained after surgery |
Day 3
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C-reactive protein
Tijdsspanne: Day 1
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The inflammatory marker of participants will be test after surgery |
Day 1
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interleukin-6
Tijdsspanne: Day 1
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The inflammatory marker of participants will be test after surgery |
Day 1
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postoperative delusion
Tijdsspanne: Day 3
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The incidence of postoperative delusion. |
Day 3
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drainage extraction
Tijdsspanne: up to 24 hours (before extubation)
|
The time taken for the patient to remove the drain after surgery |
up to 24 hours (before extubation)
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ICU stay time
Tijdsspanne: From date of ICU admission until the date of leaving ICU, assessed up to 5 days.
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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.
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postoperative pulmonary complications
Tijdsspanne: Day 3
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The probability of patients acquiring pulmonary complications after surgery. |
Day 3
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hospital length of stay
Tijdsspanne: 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.
|
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healing rate of drainage wound
Tijdsspanne: Day 21
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The healing rate of drainage wound at 21 days after surgery. |
Day 21
|
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readmission rate
Tijdsspanne: Month 1
|
The readmission rate of patients in one month after surgery. |
Month 1
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
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- Gupta PK, Pace NL, Hopkins PM. Effect of body mass index on the ED50 volume of bupivacaine 0.5% for supraclavicular brachial plexus block. Br J Anaesth. 2010 Apr;104(4):490-5. doi: 10.1093/bja/aeq017. Epub 2010 Feb 18.
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- Green SB. How Many Subjects Does It Take To Do A Regression Analysis. Multivariate Behav Res. 1991 Jul 1;26(3):499-510. doi: 10.1207/s15327906mbr2603_7.
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pijn
- Neurologische manifestaties
- Ziekten van het zenuwstelsel
- Postoperatieve complicaties
- Pathologische processen
- Neurologische gedragsmanifestaties
- Perceptuele stoornissen
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Pijn, postoperatief
- Agnosie
- Organische chemicaliën
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Anilides
- Amides
- Aniline -verbindingen
- Amines
- Acetaniliden
- Piperidines
- Fentanyl
- Lidocaïne
- Sufentanil
Andere studie-ID-nummers
- KYLL-202210-071-1
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