Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery
1 januari 2020 uppdaterad av: Han Yuan, Xuzhou Medical University
Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial
This project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (CPSP) in thoracic postoperative patients.
Related clinical characteristics of postoperative chronic pain.
The results of the study provide clinicians with a simple and inexpensive new method of preventing CPSP, in order to prevent the occurrence of CPSP and reduce the incidence of CPSP, thereby reducing CPSP to patients and their families, hospitals.
And public resources.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
124
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Jiangsu
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Xuzhou, Jiangsu, Kina, 225000
- Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Age ≥18 years old, conscious;
- ASA class Ⅰ ~ Ⅲ;
- Thoracoscopic lobectomy was proposed;
- The han nationality;
- Native speaker of Chinese;
- Agree to participate in this study and sign the informed consent.
Exclusion Criteria:
- Patients allergic to meccobalamin or ropivacaine;
- Patients with previous history of chest surgery;
- Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture;
- Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease;
- Diabetic patients;
- Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: ropivacaine combined with mecobalamine
Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).
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In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity.
5ml was injected into each intercostal nerve block.
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Aktiv komparator: ropivacaine
Intercostal nerve block with 0.5% ropivacaine alone.
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In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity.
5ml was injected into each intercostal nerve block.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of chronic pain after chest surgery
Tidsram: At the 3rd month after surgery
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The incidence of chronic pain after chest surgery was measured by NRS(numeric rating scales) at the 3rd month after surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented "no pain" and a score of 10 represented "worst pain imaginable".
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At the 3rd month after surgery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The incidence of acute pain after chest surgery
Tidsram: 24 to 72 hours after surgery
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An NRS score was performed 24 to 72 hours after surgery to determine the incidence of acute pain after thoracic surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented "no pain" and a score of 10 represented "worst pain imaginable".
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24 to 72 hours after surgery
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Incidence of postoperative neuropathic pain
Tidsram: At the 3rd month after surgery
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The incidence of neuropathic pain was measured by DN4 scale at the 3rd month after surgery.Douleur Neuropathique 4 (DN4) is a screening questionnaire to help identify neuropathic pain (NP) in clinical practice and research,where a DN4 scores greater than or equal to 4 represented the patients had "postoperative neuropathic pain".
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At the 3rd month after surgery
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Incidence of other postoperative complications
Tidsram: At the 3rd month after surgery
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Postoperative complications included that pulmonary complications, delirium, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, incision infection, cerebrovascular accident and other complications related to surgery.
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At the 3rd month after surgery
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Incidence of readmission within 30 days after surgery
Tidsram: At the 30 days after surgery
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The incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up.
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At the 30 days after surgery
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Incidence of death within 30 days after surgery
Tidsram: At the 30 days after surgery
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The incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up
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At the 30 days after surgery
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Length of stay
Tidsram: At the 3rd month after surgery
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The total length of hospital stay.
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At the 3rd month after surgery
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Cost of stay
Tidsram: At the 3rd month after surgery
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The total cost of hospital stay.
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At the 3rd month after surgery
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icu length of stay
Tidsram: At the 3rd month after surgery
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The number of hours of postoperative stay in ICU.
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At the 3rd month after surgery
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Incidence of secondary operation
Tidsram: At the 3rd month after surgery
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Whether the patient has a second operation and the reason and the incidence of this operation.
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At the 3rd month after surgery
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 januari 2020
Primärt slutförande (Förväntat)
30 juni 2020
Avslutad studie (Förväntat)
30 november 2020
Studieregistreringsdatum
Först inskickad
30 november 2019
Först inskickad som uppfyllde QC-kriterierna
1 januari 2020
Första postat (Faktisk)
3 januari 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 januari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 januari 2020
Senast verifierad
1 januari 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- XYFY2019-KL169-01
Läkemedels- och apparatinformation, studiedokument
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