Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effekten af ​​Erector Spinae Plane (ESP) blok hos patienter med inflammatorisk tarmsygdom (IBD)

22. september 2026 opdateret af: Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Effekten af ​​Erector Spinae Plane (ESP) blok hos patienter med inflammatorisk tarmsygdom (IBD), der gennemgår større abdominal kirurgi: et dobbeltblindt randomiseret kontrolforsøg

This will be a prospective, double-blind randomized controlled clinical trial. There will be two arms of treatment: intervention and control group. Preoperatively patients will be allocated at random to receive ultrasound guided bilateral ESP block either with the local anesthetic (intervention group) normal saline (control group). The aim of this study is to examine the effect of ESP block to increase the Quality of Recovery (measured via QoR-15 total score) and decrease opioid consumption.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Work Plan: This prospective trial would include Inflammatory Bowel Disease (IBD) patients undergoing laparoscopic or laparoscopic assisted abdominal surgery. Patients generally have pre-anesthetic visits 1-2 weeks prior to their scheduled operation. Patients identified by the clinical Research Study Assistant (CRSA) based on inclusion and exclusion criteria, will be approached regarding this study in the pre-anesthetic clinic. Patients will be made aware of the components of the study and the CRSA will be present to answer any questions. Patients will be allocated at random to receive ultrasound guided (Erector spinae plane) ESP block either with the local anesthetic of 0.5% of Ropivicane 20 mL bilaterally (intervention group) or normal saline (control group) before surgery which will take 5-10 minutes in a 1:1 ratio. Anesthesiologist and patients will be blinded of the allocation. Allocation sequence will be concealed using opaque, sealed, consecutively numbered envelopes. Written informed consent will be obtained from all participants after confirmation of eligibility. Baseline measurements will be made by the CRSA in the pre-anesthetic Clinic. The study coordinator will collect the data once a day for maximum 10 minutes each time up to 3 days postoperatively. There will be a virtual (via telephone) follow up data for quality of life (QoL) at "6 weeks" post-discharge. Sample Size: Sample size justification was based on the primary outcome, QoR15, and the primary objective. According to the previous report10 and our preliminary data, the mean (std) of the total score of QoR15 (quality of recovery) was conservatively assumed as 98 for patients in control group. The investigators estimated a sample size of 84 (42 per group) will achieve 80% power to detect an absolute 10 point increase in total score of QoR15 for patients in intervention group compared to the control group. A two-sided two-sample equal-variance t-test was used for the power analysis assuming a significance level of 0.05. To account for possible 5% lost follow up, the investigators will recruit a total of 90 patients for this study.

Performance of ESP block: Patient Selection. A thorough history, physical exam, and informed consent are carried out. Altered mental status, concomitant injuries, and intubation/ ventilation are considerations primarily with regard to the ability to position the patient safely and access the Paraspinal area to perform the block. The investigators do not view coagulopathy or the use of anticoagulants or antiplatelet drugs as absolute contraindications to ESP block because the theoretical risk of clinically significant hemorrhage or hematoma is very low; however, an individualized risk-benefit assessment should be performed for every patient. Block Equipment and Preparation. In the majority of patients, the investigators will use a high-frequency (10-15 MHz) linear-array transducer because it provides a higher-resolution image; however, a low-frequency (5-2 MHz) curvilinear probe is useful in more obese patients where the transverse processes lie at a depth greater than 4 cm. The block is performed before induction of anesthesia with full aseptic precautions, and the usual precautions for any regional anesthesia procedures will be applied. Scanning Technique. After patients are positioned optimally (sitting or lateral decubitus), the affected area is identified along with the target transverse process. The ultrasound transducer is placed in a longitudinal parasagittal orientation, about 3 cm lateral to the spinous processes, allowing for visualization of adjacent transverse processes (TP) in an in-plane approach. These are recognizable as flat, squared-off acoustic shadows with only a very faint image of the pleura visible. After correct TP identification, an 22-gauge echogenic needle (Pajunk E-Cath, Pajunk Medical Systems) is inserted using an in-plane, cranial-to-caudal approach to contact the bony shadow of the TP with the tip deep to the fascial plane of the erector spinae muscle. The correct location of the needle tip is confirmed by injecting 0.5-1 ml of normal saline 0.9% and observing linear fluid spread lifting the erector spinae muscle off the tip of the TP. Once the fascial plane is recognized, 20 mL of ropivacaine 0.5% is injected and cranial and caudal spread of local anesthetic can be visualized.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

67

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Ontario
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Adults (18-85 years old) diagnosed with IBD
  2. ASA physical status I-III
  3. IBD abdominal laparoscopic assisted surgeries under general anesthesia

Exclusion Criteria:

  1. Unable to communicate in English
  2. Unstable requiring emergency surgery
  3. Open laparotomies
  4. Morbidly obese
  5. Pregnant
  6. On chronic opioid treatment
  7. Known allergies to local anesthetics
  8. Altered mental status
  9. Concomitant injuries.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Intervention group

Ultrasound guided bilateral ESP block either with local anesthetic

Ultrasound guided ESP block either with the local anesthetic of 0.5% of Ropivicane 20 mL bilaterally (intervention group) or normal saline (control group) before surgery which will take 5-10 minutes in a 1:1 ratio.

Placebo komparator: Control group

Ultrasound guided bilateral ESP block either with normal saline

Ultrasound guided bilateral ESP block either with normal saline

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Recovery (via QoR-15) total score.The 48-hour/postoperative day 2 assessment represented the respecified primary analysis timepoint.
Tidsramme: baseline, 24 hours, 48 hours and 72 hours postoperatively

This will be measured via QoR-15 (Quality of Recovery-15 questionnaire) where, "0" means the worst and "15" the best outcome.

baseline, 24 hours, 48 hours and 72 hours postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The intensity of postoperative pain
Tidsramme: baseline, 24 hours, 48 hours and 72 hours postoperatively

Pain will be measured by Visual Analog Scale (VAS) at rest and movement once a day using categorical pain scoring system. The scores are from 1 to 10, in which, 10 is the worse pain.

baseline, 24 hours, 48 hours and 72 hours postoperatively
Opioid consumption
Tidsramme: 24 hours, 48 hours and 72 hours postoperatively

Total opioid consumption will be measured as 24-hour PCA usage each day up to 3 days postoperatively

24 hours, 48 hours and 72 hours postoperatively
Opioid related side effects
Tidsramme: baseline, 24 hours, 48 hours and 72 hours postoperatively

The side effects of opioids will be measured using Opioid-related symptom Distress Scale (ORSDS). The answers to each side effects will be either "ye" or "no".

baseline, 24 hours, 48 hours and 72 hours postoperatively
The hospital LOS
Tidsramme: From admission to the hospital until discharge, an average of 5 days

The hospital length of stay

From admission to the hospital until discharge, an average of 5 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Naveed Siddiqui, MD, Associate Professor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. juli 2021

Primær færdiggørelse (Faktiske)

17. december 2024

Studieafslutning (Faktiske)

1. marts 2025

Datoer for studieregistrering

Først indsendt

24. november 2023

Først indsendt, der opfyldte QC-kriterier

26. januar 2024

Først opslået (Faktiske)

29. januar 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2026

Sidst verificeret

1. februar 2024

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner