Jatkuva lidokaiini-infuusio suljetun rintakehän tyhjennysputken kautta kivunhallintaan torakoskooppisen osittaisen keuhkojen resektion jälkeen
Jatkuvan lidokaiini-infuusion vaikutukset suljetun rintakehän tyhjennysputken kautta leikkauksen jälkeiseen kivunlievitykseen potilailla, joille tehdään torakoskooppinen osittainen keuhkojen resektio: yhden keskuksen satunnaistettu kontrolloitu kliininen tutkimus
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Shandong
-
Jinan, Shandong, Kiina
- Qilu Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
|
Active Comparator: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
postoperative pain score（NRS）
Aikaikkuna: Day 1
|
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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Changes in postoperative pain
Aikaikkuna: 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
Aikaikkuna: Day 3
|
the amount of rescue analgesic drugs flurbiprofen axetil used |
Day 3
|
|
the use of dolantin
Aikaikkuna: Day 3
|
the amount of rescue analgesic drugs dolantin used |
Day 3
|
|
the use of opioids
Aikaikkuna: Day 2
|
total amount of opioid use within 48h after surgery |
Day 2
|
|
postoperative adverse events
Aikaikkuna: Day 3
|
the incidence of nausea, vomiting, and vertigo after surgery |
Day 3
|
|
the amount of postoperative wound drainage
Aikaikkuna: Day 3
|
total amount of fluid drained after surgery |
Day 3
|
|
C-reactive protein
Aikaikkuna: Day 1
|
The inflammatory marker of participants will be test after surgery |
Day 1
|
|
interleukin-6
Aikaikkuna: Day 1
|
The inflammatory marker of participants will be test after surgery |
Day 1
|
|
postoperative delusion
Aikaikkuna: Day 3
|
The incidence of postoperative delusion. |
Day 3
|
|
drainage extraction
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Day 3
|
The probability of patients acquiring pulmonary complications after surgery. |
Day 3
|
|
hospital length of stay
Aikaikkuna: 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
Aikaikkuna: Day 21
|
The healing rate of drainage wound at 21 days after surgery. |
Day 21
|
|
readmission rate
Aikaikkuna: Month 1
|
The readmission rate of patients in one month after surgery. |
Month 1
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
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Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Kipu
- Neurologiset ilmenemismuodot
- Hermoston sairaudet
- Postoperatiiviset komplikaatiot
- Patologiset prosessit
- Neurokäyttäytymisoireet
- Havaintohäiriöt
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Kipu, Leikkauksen jälkeinen
- Agnosia
- Orgaaniset kemikaalit
- Heterosykliset yhdisteet, 1-rengas
- Heterosykliset yhdisteet
- Anilidit
- Amidit
- Aniliiniyhdisteet
- Amiini
- Asetanilidit
- Piperidiinit
- Fentanyyli
- Lidokaiini
- Sufentaniili
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- KYLL-202210-071-1
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