Kontinuerlig lidokaininfusjon via lukket brystdreneringsrør for smertekontroll etter torakoskopisk delvis lungereseksjon
Effekter av kontinuerlig lidokain-infusjon via lukket brystdreneringsrør på postoperativ analgesi for pasienter som gjennomgår torakoskopisk partiell lunge-reseksjon: et enkeltsenter randomisert kontrollert klinisk forsøk
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Shandong
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Jinan, Shandong, Kina
- Qilu Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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. |
|
Aktiv 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
postoperative pain score（NRS）
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in postoperative pain
Tidsramme: 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
Tidsramme: Day 3
|
the amount of rescue analgesic drugs flurbiprofen axetil used |
Day 3
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the use of dolantin
Tidsramme: Day 3
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the amount of rescue analgesic drugs dolantin used |
Day 3
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the use of opioids
Tidsramme: Day 2
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total amount of opioid use within 48h after surgery |
Day 2
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postoperative adverse events
Tidsramme: Day 3
|
the incidence of nausea, vomiting, and vertigo after surgery |
Day 3
|
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the amount of postoperative wound drainage
Tidsramme: Day 3
|
total amount of fluid drained after surgery |
Day 3
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C-reactive protein
Tidsramme: Day 1
|
The inflammatory marker of participants will be test after surgery |
Day 1
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interleukin-6
Tidsramme: Day 1
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The inflammatory marker of participants will be test after surgery |
Day 1
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postoperative delusion
Tidsramme: Day 3
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The incidence of postoperative delusion. |
Day 3
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drainage extraction
Tidsramme: 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
Tidsramme: 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.
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postoperative pulmonary complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 21
|
The healing rate of drainage wound at 21 days after surgery. |
Day 21
|
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readmission rate
Tidsramme: Month 1
|
The readmission rate of patients in one month after surgery. |
Month 1
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
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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.
- 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.
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- 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.
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Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Smerte
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Postoperative komplikasjoner
- Patologiske prosesser
- Nevroatferdsmanifestasjoner
- Perseptuelle forstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Smerter, postoperativt
- Agnosia
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Anilider
- Amides
- Anilinforbindelser
- Aminer
- Acetanilider
- Piperidines
- Fentanyl
- Lidokain
- Sufentanil
Andre studie-ID-numre
- KYLL-202210-071-1
Legemiddel- og utstyrsinformasjon, studiedokumenter
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