Prolonged Multimodal Analgesia for Postsurgical Pain
The Effect of Prolonged Multimodal Analgesia Strategy on Postoperative Pain in Patients Undergoing Spine Surgery
Chronic pain is one of the common postoperative complications in major surgery patients, which seriously affects the prognosis of patients. The postoperative pain level in spinal cord surgery patients is severe, and the incidence of CPSP can be as high as 40%.
Prolonged multimodal analgesia strategies using non-opioid or low-opioid receptor agonists can safely extend the postoperative pain window to one month, thereby further avoiding the occurrence of chronic postoperative pain.
This study provides guidance for perioperative pain management strategies in spinal surgery patients and further improves their long-term prognosis and outcomes.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Zhou Yang, Medical Doctor
- Telefonnummer: 59976660
- E-mail: weiru1991@hotmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years;
- Scheduled for elective spinal surgery;
- American Society of Anesthesiologists (ASA) physical status I-III;
- Presence of preoperative pain symptoms;
- Provision of written informed consent.
Exclusion Criteria:
- History of allergy to gabapentinoids, ketamine, or related medications;
- Inability to cooperate with scale assessments due to conditions such as aphasia;
- Presence of psychiatric disorders;
- Presence of significant organ dysfunction (heart, lung, liver, or kidney) meeting any of the following criteria;
- Presence of severe sinus bradycardia or other comorbidities rendering the patient unsuitable for completing the study intervention;
- History of illicit drug or medication abuse;
- Body mass index (BMI) ≥ 35 kg/m²;
- Pregnant or lactating patients.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Prolonged Multimodal Analgesia Group
Pre-operative (1 hour): pregabalin 150mg; Intraoperative: Esketamine 0.09 mg/kg/h pumping; Post-operative: Esketamine combined with dexmedetomidine PCA: the esketamine dosage is 0.06 mg/kg/h, dexmedetomidine dosage is 1.5 μg/kg, and the PCA pump is used for 48 hours; Pregabalin 75 mg bid in 1-7 days and Pregabalin 75 mg qd in 8-21days. The anesthesiologist may adjust the drug dosage as appropriate based on the patient's condition, and all medications administered must be documented in detail. drugs:Esketamine, dexmedetomidine, pregabalin device:Patient Controlled Analgesia(PCA) |
Pre-operative (1 hour): pregabalin 150mg; Intraoperative: Esketamine 0.09 mg/kg/h pumping; Post-operative: Esketamine combined with dexmedetomidine PCA: the esketamine dosage is 0.06 mg/kg/h, dexmedetomidine dosage is 1.5 μg/kg, and the PCA pump is used for 48 hours; Pregabalin 75 mg bid in 1-7 days and Pregabalin 75 mg qd in 8-21days. The anesthesiologist may adjust the drug dosage as appropriate based on the patient's condition, and all medications administered must be documented in detail. drugs:Esketamine, dexmedetomidine, pregabalin device:Patient Controlled Analgesia(PCA) |
|
Aktiv komparator: Conventional Analgesia Group
The participant will be administrated by Sulfentanil PCA (1.5μg/kg) in postoperative 48h. The anesthesiologist may adjust the drug dosage as appropriate based on the patient's condition, and all medications administered must be documented in detail. |
Using sufentanil PCA pump for 48 h. The sufentanil dosage is 1.5μg/kg. The anesthesiologist may adjust the drug dosage as appropriate based on the patient's condition, and all medications administered must be documented in detail. drugs:sufentanil device: Patient Controlled Analgesia(PCA) |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of moderate-to-severe chronic pain at 3 months postoperatively
Tidsramme: postoperative 3 months
|
postoperative 3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Smerte
- Neurologiske manifestationer
- Postoperative komplikationer
- Patologiske processer
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Smerter, postoperativ
- Aminosyrer, peptider og proteiner
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Azoler
- Syrer, acyklisk
- Carboxylsyrer
- Imidazoler
- Piperidiner
- Aminosyrer
- Gamma-Aminobutyric Acid
- Aminobutyrater
- Butyrater
- Fentanyl
- Pregabalin
- Esketamin
- Dexmedetomidin
- Sufentanil
Andre undersøgelses-id-numre
- Longanalgia251130
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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