Ciągły wlew lidokainy przez zamkniętą rurkę drenującą klatkę piersiową w celu opanowania bólu po torakoskopowej częściowej resekcji płuca
Wpływ ciągłego wlewu lidokainy przez zamkniętą rurkę do drenażu klatki piersiowej na analgezję pooperacyjną u pacjentów poddawanych torakoskopowej częściowej resekcji płuca: jednoośrodkowe, randomizowane, kontrolowane badanie kliniczne
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Shandong
-
Jinan, Shandong, Chiny
- Qilu Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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. |
|
Aktywny komparator: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
postoperative pain score（NRS）
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Changes in postoperative pain
Ramy czasowe: 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
Ramy czasowe: Day 3
|
the amount of rescue analgesic drugs flurbiprofen axetil used |
Day 3
|
|
the use of dolantin
Ramy czasowe: Day 3
|
the amount of rescue analgesic drugs dolantin used |
Day 3
|
|
the use of opioids
Ramy czasowe: Day 2
|
total amount of opioid use within 48h after surgery |
Day 2
|
|
postoperative adverse events
Ramy czasowe: Day 3
|
the incidence of nausea, vomiting, and vertigo after surgery |
Day 3
|
|
the amount of postoperative wound drainage
Ramy czasowe: Day 3
|
total amount of fluid drained after surgery |
Day 3
|
|
C-reactive protein
Ramy czasowe: Day 1
|
The inflammatory marker of participants will be test after surgery |
Day 1
|
|
interleukin-6
Ramy czasowe: Day 1
|
The inflammatory marker of participants will be test after surgery |
Day 1
|
|
postoperative delusion
Ramy czasowe: Day 3
|
The incidence of postoperative delusion. |
Day 3
|
|
drainage extraction
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Day 3
|
The probability of patients acquiring pulmonary complications after surgery. |
Day 3
|
|
hospital length of stay
Ramy czasowe: 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
Ramy czasowe: Day 21
|
The healing rate of drainage wound at 21 days after surgery. |
Day 21
|
|
readmission rate
Ramy czasowe: Month 1
|
The readmission rate of patients in one month after surgery. |
Month 1
|
Współpracownicy i badacze
Publikacje i pomocne linki
Publikacje ogólne
- Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.
- Grape S, Kirkham KR, Baeriswyl M, Albrecht E. The analgesic efficacy of sciatic nerve block in addition to femoral nerve block in patients undergoing total knee arthroplasty: a systematic review and meta-analysis. Anaesthesia. 2016 Oct;71(10):1198-209. doi: 10.1111/anae.13568. Epub 2016 Jul 29.
- O'Donnell BD, Iohom G. An estimation of the minimum effective anesthetic volume of 2% lidocaine in ultrasound-guided axillary brachial plexus block. Anesthesiology. 2009 Jul;111(1):25-9. doi: 10.1097/ALN.0b013e3181a915c7.
- 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.
- Capdevila X, Pirat P, Bringuier S, Gaertner E, Singelyn F, Bernard N, Choquet O, Bouaziz H, Bonnet F; French Study Group on Continuous Peripheral Nerve Blocks. Continuous peripheral nerve blocks in hospital wards after orthopedic surgery: a multicenter prospective analysis of the quality of postoperative analgesia and complications in 1,416 patients. Anesthesiology. 2005 Nov;103(5):1035-45. doi: 10.1097/00000542-200511000-00018.
- Nathan N, Benrhaiem M, Lotfi H, Debord J, Rigaud G, Lachatre G, Adenis JP, Feiss P. The role of hyaluronidase on lidocaine and bupivacaine pharmacokinetics after peribulbar blockade. Anesth Analg. 1996 May;82(5):1060-4. doi: 10.1097/00000539-199605000-00032.
- Keplinger M, Marhofer P, Marhofer D, Schroegendorfer K, Haslik W, Zeitlinger M, Mayer CV, Kettner SC. Effective local anaesthetic volumes for sciatic nerve blockade: a clinical evaluation of the ED99. Anaesthesia. 2015 May;70(5):585-90. doi: 10.1111/anae.13013. Epub 2015 Jan 20.
- Latzke D, Marhofer P, Zeitlinger M, Machata A, Neumann F, Lackner E, Kettner SC. Minimal local anaesthetic volumes for sciatic nerve block: evaluation of ED 99 in volunteers. Br J Anaesth. 2010 Feb;104(2):239-44. doi: 10.1093/bja/aep368. Epub 2009 Dec 23.
- De Buck F, Devroe S, Missant C, Van de Velde M. Regional anesthesia outside the operating room: indications and techniques. Curr Opin Anaesthesiol. 2012 Aug;25(4):501-7. doi: 10.1097/ACO.0b013e3283556f58.
- 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.
- Abdallah FW, Brull R. Is sciatic nerve block advantageous when combined with femoral nerve block for postoperative analgesia following total knee arthroplasty? A systematic review. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):493-8. doi: 10.1097/AAP.0b013e318228d5d4.
- Barletta M, Reed R. Local Anesthetics: Pharmacology and Special Preparations. Vet Clin North Am Small Anim Pract. 2019 Nov;49(6):1109-1125. doi: 10.1016/j.cvsm.2019.07.004. Epub 2019 Aug 30.
- Becker DE, Reed KL. Local anesthetics: review of pharmacological considerations. Anesth Prog. 2012 Summer;59(2):90-101; quiz 102-3. doi: 10.2344/0003-3006-59.2.90.
- Camorcia M, Capogna G, Columb MO. Effect of sex and pregnancy on the potency of intrathecal bupivacaine: determination of ED(5)(0) for motor block with the up-down sequential allocation method. Eur J Anaesthesiol. 2011 Apr;28(4):240-4.
- Choquet O, Noble GB, Abbal B, Morau D, Bringuier S, Capdevila X. Subparaneural versus circumferential extraneural injection at the bifurcation level in ultrasound-guided popliteal sciatic nerve blocks: a prospective, randomized, double-blind study. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):306-11. doi: 10.1097/AAP.0000000000000095.
- Dalkilic N, Tuncer S, Burat I. Dexmedetomidine augments the effect of lidocaine: power spectrum and nerve conduction velocity distribution study. BMC Anesthesiol. 2015 Mar 6;15:24. doi: 10.1186/s12871-015-0009-9. eCollection 2015.
- Drachman D, Strichartz G. Potassium channel blockers potentiate impulse inhibition by local anesthetics. Anesthesiology. 1991 Dec;75(6):1051-61. doi: 10.1097/00000542-199112000-00018.
- Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60.
- Elmas C, Atanassoff PG. Combined inguinal paravascular (3-in-1) and sciatic nerve blocks for lower limb surgery. Reg Anesth. 1993 Mar-Apr;18(2):88-92.
- He M, Ling DD, Cai GY, Zou TX, Yu B. Two different placement paths in popliteal fossa with a novel nerve block needle for postoperative analgesia after foot and ankle surgery. Minerva Anestesiol. 2018 May;84(5):582-589. doi: 10.23736/S0375-9393.17.12061-4. Epub 2017 Oct 12.
- Kang R, Jeong JS, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Huh J, Ko JS. Effective Dose of Intravenous Dexmedetomidine to Prolong the Analgesic Duration of Interscalene Brachial Plexus Block: A Single-Center, Prospective, Double-Blind, Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Jul;43(5):488-495. doi: 10.1097/AAP.0000000000000773.
- Kettner SC, Willschke H, Marhofer P. Does regional anaesthesia really improve outcome? Br J Anaesth. 2011 Dec;107 Suppl 1:i90-5. doi: 10.1093/bja/aer340.
- Lirk P, Hollmann MW, Strichartz G. The Science of Local Anesthesia: Basic Research, Clinical Application, and Future Directions. Anesth Analg. 2018 Apr;126(4):1381-1392. doi: 10.1213/ANE.0000000000002665.
- Marhofer P, Pilz-Lubsczyk B, Lonnqvist PA, Fleischmann E. Ultrasound-guided peripheral regional anaesthesia: a feasibility study in obese versus normal-weight women. Int J Obes (Lond). 2014 Mar;38(3):451-5. doi: 10.1038/ijo.2013.119. Epub 2013 Jun 25.
- Palmer CG, Jagannathan S. Sciatic nerve block and enhanced recovery after total knee arthroplasty. Anaesthesia. 2016 Dec;71(12):1495. doi: 10.1111/anae.13728. No abstract available.
- Raymond SA, Steffensen SC, Gugino LD, Strichartz GR. The role of length of nerve exposed to local anesthetics in impulse blocking action. Anesth Analg. 1989 May;68(5):563-70.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Ból
- Objawy neurologiczne
- Choroby Układu Nerwowego
- Powikłania pooperacyjne
- Procesy patologiczne
- Manifestacje neurobehawioralne
- Zaburzenia percepcyjne
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Ból, pooperacyjny
- Agnozja
- Organiczne chemikalia
- Związki heterocykliczne, 1-ring
- Związki heterocykliczne
- Anilidy
- Amides
- Związki aniliny
- Aminy
- Acetanilidy
- Piperydyny
- Fentanyl
- Lidokaina
- Sufentanyl
Inne numery identyfikacyjne badania
- KYLL-202210-071-1
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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