NCT05512897

Brief Summary

The patients will be randomly assigned to standard therapy or standard therapy+ESP nerve block. After surgery pain level and narcotic consumption will be measured, and vital signs and side effects will bo monitored for up to 72 hours. 6 months after surgery a phone interview will be conducted to asses chronic pain

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

August 11, 2022

Last Update Submit

August 21, 2022

Conditions

Post Operative PainRegional Anesthesia MorbidityOpioid-Related DisordersChronic Pain

Keywords

erector spinea blockpost operative painpost operative opioid consumptionpost operative chronic painopioids side effects

Outcome Measures

Primary Outcomes (12)

  • VAS score

    the patients reported pain level using the VAS score

    postoperative - 1 hour

  • VAS score

    the patients reported pain level using the VAS score

    postoperative - 4 hour

  • VAS score

    the patients reported pain level using the VAS score

    postoperative - 8 hour

  • VAS score

    the patients reported pain level using the VAS score

    postoperative - 12 hour

  • VAS score

    the patients reported pain level using the VAS score

    postoperative - 24 hour

  • VAS score

    the patients reported pain level using the VAS score

    postoperative - 48 hour

  • VAS score

    the patients reported pain level using the VAS score

    postoperative - 72 hour

  • VAS score

    the patients reported pain level using the VAS score

    day 7 postoperative

  • VAS score

    the patients reported pain level using the VAS score

    day 14 postoperative

  • VAS score

    the patients reported pain level using the VAS score

    day 21 postoperative

  • opioid consumption

    total morphine administered (in mg)

    postoperative - 24 hours

  • opioid consumption

    total morphine administered (in mg)

    postoperative - 72 hours

Secondary Outcomes (21)

  • heart rate

    postoperative - 1 hour

  • heart rate

    postoperative - 4 hour

  • heart rate

    postoperative - 8 hour

  • heart rate

    postoperative - 12 hour

  • heart rate

    postoperative - 24 hour

  • +16 more secondary outcomes

Study Arms (2)

standard care

NO INTERVENTION

standard analgesic treatment

standard care + ESP block

EXPERIMENTAL

intraoperativeESP block + standard analgesic treatment

Procedure: erector spinea plane block

Interventions

erector spinea plane blockPROCEDURE

in assistance of ultrasound for visualization anesthetic injection point. 30-40 mL Ropivacaine 0.375% plus 2 mg Dexamethasone administered on each side will be administered between thoracic transversus process and longitudinal spine muscle

standard care + ESP block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing thoracic surgery, older ≥18 years
  • Patients who meet criteria of ASA (american society of anesthesiologists) physical status I-II-III class.

You may not qualify if:

  • Patients who will be unconscious or mentally incompetent
  • Patients refusal to participate in the study
  • ASA -IV -V
  • Patient with coagulopathy
  • Hemodynamically unstable (systolic blood pressure \< 90, heart rate (HR) \> 100)
  • Allergy to local anesthetic drugs or opioids
  • Pregnant patient
  • History of opioid abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Hospital

Beersheba, Israel

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeOpioid-Related DisordersChronic Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

michael dubilet, md

CONTACT

972-54-6260728mikl.dubilet@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The block will be preformed under anesthesia. The patients will not know what intervention group they are allocated
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized to 2 groups - standard care vs standard care+ESP block
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
head of acute pain care unit

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 23, 2022

Study Start

September 1, 2020

Primary Completion

September 1, 2023

Study Completion

February 1, 2024

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)