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Does ESP Block Reduce Pain and Opiates Consumption After Surgery

Primary Purpose

Post Operative Pain, Regional Anesthesia Morbidity, Opioid-Related Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
erector spinea plane block
Sponsored by
Michael Dubilet MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring erector spinea block, post operative pain, post operative opioid consumption, post operative chronic pain, opioids side effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Soroka HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard care

standard care + ESP block

Arm Description

standard analgesic treatment

intraoperativeESP block + standard analgesic treatment

Outcomes

Primary Outcome Measures

VAS score
the patients reported pain level using the VAS score
VAS score
the patients reported pain level using the VAS score
VAS score
the patients reported pain level using the VAS score
VAS score
the patients reported pain level using the VAS score
VAS score
the patients reported pain level using the VAS score
VAS score
the patients reported pain level using the VAS score
VAS score
the patients reported pain level using the VAS score
VAS score
the patients reported pain level using the VAS score
VAS score
the patients reported pain level using the VAS score
VAS score
the patients reported pain level using the VAS score
opioid consumption
total morphine administered (in mg)
opioid consumption
total morphine administered (in mg)

Secondary Outcome Measures

heart rate
postoperative heart rate
heart rate
postoperative heart rate
heart rate
postoperative heart rate
heart rate
postoperative heart rate
heart rate
postoperative heart rate
blood pressure
postoperative blood pressure - systolic and diastolic
blood pressure
postoperative blood pressure - systolic and diastolic
blood pressure
postoperative blood pressure - systolic and diastolic
blood pressure
postoperative blood pressure - systolic and diastolic
blood pressure
postoperative blood pressure - systolic and diastolic
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
chronic pain - VAS
patient's self reported current pain score (VAS) over a telephone interview
chronic pain - VAS
patient's self reported current pain score (VAS) over a telephone interview
chronic pain - opioid use
patient's self reported current use of opioids over a telephone interview
chronic pain - opioid use
patient's self reported current use of opioids over a telephone interview
chronic pain - sleep
patient's self reported difficulty sleeping due to pain over a telephone interview
chronic pain - sleep
patient's self reported difficulty sleeping due to pain over a telephone interview

Full Information

First Posted
August 11, 2022
Last Updated
August 21, 2022
Sponsor
Michael Dubilet MD
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1. Study Identification

Unique Protocol Identification Number
NCT05512897
Brief Title
Does ESP Block Reduce Pain and Opiates Consumption After Surgery
Official Title
Compared Erector Spinae Plane Block (ESP) Block for Pain Control With Traditional Pain Management Techniques in Patient Undergoing Thoracic and Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Dubilet MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
patients will be divided randomly into two groups before the beginning of operation: Group 1: patients will be treated to standard pain control treatment ; Group 2: patients will receive Erector spinea block (30-40 mL Ropivacaine 0.375% plus 2 mg Dexamethasone injection using ultrasound approach) additionally to standard pain control treatment The ESB (erector spinae plane block) will be performed at the beginning of the procedure while the patient under general anesthesia, in assistance of ultrasound for visualization, anesthetic injection 30-40 mL Ropivacaine 0.375% plus 2 mg Dexamethasone administered on each side between thoracic transversus process and longitudinal spinea muscle. in the the postoperative care room, the vital sings and pain level will be continuously monitored. During the postoperative period stay the pain level of each patient will be assessed by of Visual Analog Score of pain (VAS: 0-10) interviewing the patient every 30 minutes from the patient's admission from operation room and thereafter every 1 - 4 -8 -12 -24 -48 - 72 hours, at discharge, 7- 14-21 days. For a more accurate assessment of pain, a pre-operative baseline level of pain eill be recorded. Any postoperative pain will be routinely managed by 5-10 mg of intravenous morphine to achieve a VAS scale of none or mild pain (1-5). investigators will also continue to record events of postoperative nausea and vomiting (PONV) within 24 hours after procedure. The PONV will be assessed by the PONV Impact Scale score, based on numerical responses to questions. A PONV Impact Scale score of ≥5 defines clinically relevant PONV. Recording of urinary retention, constipation, opioid requirements and itching will also be preformed. After 3 and 6 months a telephone survey will be preformed - recording pain related to surgery and to asses chronic pain syndrome. During the phone conversation, patients will be asked to answer by the brief pain inventory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Regional Anesthesia Morbidity, Opioid-Related Disorders, Chronic Pain
Keywords
erector spinea block, post operative pain, post operative opioid consumption, post operative chronic pain, opioids side effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to 2 groups - standard care vs standard care+ESP block
Masking
Participant
Masking Description
The block will be preformed under anesthesia. The patients will not know what intervention group they are allocated
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard care
Arm Type
No Intervention
Arm Description
standard analgesic treatment
Arm Title
standard care + ESP block
Arm Type
Experimental
Arm Description
intraoperativeESP block + standard analgesic treatment
Intervention Type
Procedure
Intervention Name(s)
erector spinea plane block
Intervention Description
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
Primary Outcome Measure Information:
Title
VAS score
Description
the patients reported pain level using the VAS score
Time Frame
postoperative - 1 hour
Title
VAS score
Description
the patients reported pain level using the VAS score
Time Frame
postoperative - 4 hour
Title
VAS score
Description
the patients reported pain level using the VAS score
Time Frame
postoperative - 8 hour
Title
VAS score
Description
the patients reported pain level using the VAS score
Time Frame
postoperative - 12 hour
Title
VAS score
Description
the patients reported pain level using the VAS score
Time Frame
postoperative - 24 hour
Title
VAS score
Description
the patients reported pain level using the VAS score
Time Frame
postoperative - 48 hour
Title
VAS score
Description
the patients reported pain level using the VAS score
Time Frame
postoperative - 72 hour
Title
VAS score
Description
the patients reported pain level using the VAS score
Time Frame
day 7 postoperative
Title
VAS score
Description
the patients reported pain level using the VAS score
Time Frame
day 14 postoperative
Title
VAS score
Description
the patients reported pain level using the VAS score
Time Frame
day 21 postoperative
Title
opioid consumption
Description
total morphine administered (in mg)
Time Frame
postoperative - 24 hours
Title
opioid consumption
Description
total morphine administered (in mg)
Time Frame
postoperative - 72 hours
Secondary Outcome Measure Information:
Title
heart rate
Description
postoperative heart rate
Time Frame
postoperative - 1 hour
Title
heart rate
Description
postoperative heart rate
Time Frame
postoperative - 4 hour
Title
heart rate
Description
postoperative heart rate
Time Frame
postoperative - 8 hour
Title
heart rate
Description
postoperative heart rate
Time Frame
postoperative - 12 hour
Title
heart rate
Description
postoperative heart rate
Time Frame
postoperative - 24 hour
Title
blood pressure
Description
postoperative blood pressure - systolic and diastolic
Time Frame
postoperative - 1 hour
Title
blood pressure
Description
postoperative blood pressure - systolic and diastolic
Time Frame
postoperative - 4 hour
Title
blood pressure
Description
postoperative blood pressure - systolic and diastolic
Time Frame
postoperative - 8 hour
Title
blood pressure
Description
postoperative blood pressure - systolic and diastolic
Time Frame
postoperative - 12 hour
Title
blood pressure
Description
postoperative blood pressure - systolic and diastolic
Time Frame
postoperative - 24 hour
Title
PONV
Description
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Time Frame
postoperative - 1 hour
Title
PONV
Description
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Time Frame
postoperative - 4 hour
Title
PONV
Description
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Time Frame
postoperative - 8 hour
Title
PONV
Description
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Time Frame
postoperative - 12 hour
Title
PONV
Description
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Time Frame
postoperative - 24 hour
Title
chronic pain - VAS
Description
patient's self reported current pain score (VAS) over a telephone interview
Time Frame
postoperative - 3 months
Title
chronic pain - VAS
Description
patient's self reported current pain score (VAS) over a telephone interview
Time Frame
postoperative - 6 months
Title
chronic pain - opioid use
Description
patient's self reported current use of opioids over a telephone interview
Time Frame
postoperative - 3 months
Title
chronic pain - opioid use
Description
patient's self reported current use of opioids over a telephone interview
Time Frame
postoperative - 6 months
Title
chronic pain - sleep
Description
patient's self reported difficulty sleeping due to pain over a telephone interview
Time Frame
postoperative - 3 months
Title
chronic pain - sleep
Description
patient's self reported difficulty sleeping due to pain over a telephone interview
Time Frame
postoperative - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients undergoing thoracic surgery, older ≥18 years Patients who meet criteria of ASA (american society of anesthesiologists) physical status I-II-III class. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
michael dubilet, md
Phone
972-54-6260728
Email
mikl.dubilet@gmail.com
Facility Information:
Facility Name
Soroka Hospital
City
Be'er Sheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
michael dubilet, md

12. IPD Sharing Statement

Plan to Share IPD
No

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Does ESP Block Reduce Pain and Opiates Consumption After Surgery

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