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ESP Block vs. Traditional Pain Management for ERAS

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Erector spinae plane block
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Erector spinae plane block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all consecutive adult patients who undergo thoracic, spinal or abdominal surgery in Soroka Medical Center, and agree to participate in the study, older than 18 years, who meet criteria of ASA physical status I-II-III-IV class.

Exclusion Criteria:

  • Unconscious or mentally incompetent patients or those who refuse to participate in the study.

Sites / Locations

  • SorokaUMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

No Intervention

No Intervention

No Intervention

Arm Label

Thoracic surgery + ESPblock

Abdominal surgery + ESPblock

Spinal surgery + ESPblock

Thoracic surgery

Abdominal surgery

Spinal surgery

Arm Description

Thoracic surgery + ESPblock + standard pain management

Abdominal surgery + ESPblock + standard pain management

Spinal surgery + ESPblock + standard pain management

Thoracic surgery + standard pain management

Abdominal surgery + standard pain management

Spinal surgery + standard pain management

Outcomes

Primary Outcome Measures

Visual Analog Pain Score
Reported immediate postoperative VAS score, up to 3rd day
Total pain med consumption in the PACU
Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU
Length of stay in the PACU
Length of stay in postoperative care room

Secondary Outcome Measures

Length of hospital stay
Length of hospital stay
Chronic pain development
Rate of chronic pain at 3 and 6 months after surgery

Full Information

First Posted
March 5, 2020
Last Updated
March 5, 2020
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04299035
Brief Title
ESP Block vs. Traditional Pain Management for ERAS
Official Title
Erector Spinae Plane Block Versus Traditional Pain Management for Enhanced Recovery After Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
March 5, 2021 (Anticipated)
Study Completion Date
September 5, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Patients undergoing thoracotomy, thoracoscopy or other surgical procedures involving the integrity of the chest wall are always in a special point of interest of both surgical and anesthesiological specialities. Most of the patients will describe the pain after thoracic surgery as severe. It might lead to a number of serious complications: respiratory failure due to splinting; inability to clear secretions by effective coughing, with resulting pneumonia; and turning into a chronic pain: the post-thoracotomy pain syndrome. Traditional pain management in these groups of patients - such as opiate treatment, thoracic epidural analgesia, and non-opioid drugs - may have serious side effects. Large doses of opiates suppress the cough reflex and lead to respiratory depression with subsequent re-intubation and re-ventilation. Thoracic epidural analgesia, though being considered paramount among other analgesic options, requires a significant clinical experience. Still, it might be insufficient for satisfactory pain control and even complicated with pneumothorax, total spinal anaesthesia and inadvertent intravascular injection. Non-steroidal anti-inflammatory drugs (NSAIDs) and Tramadol are weak analgesics inadequate for severe pain control and might be responsible for gastrointestinal bleeding. We suggest performing erector spinae plane block for intraoperative and postoperative pain management due to the ease of use and better analgesic effect. What remains is hard proof for the clinical efficacy and safety of this block, followed by a demonstration of the uptake of it in the hands of non-regional anaesthetists.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Erector spinae plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracic surgery + ESPblock
Arm Type
Experimental
Arm Description
Thoracic surgery + ESPblock + standard pain management
Arm Title
Abdominal surgery + ESPblock
Arm Type
Experimental
Arm Description
Abdominal surgery + ESPblock + standard pain management
Arm Title
Spinal surgery + ESPblock
Arm Type
Experimental
Arm Description
Spinal surgery + ESPblock + standard pain management
Arm Title
Thoracic surgery
Arm Type
No Intervention
Arm Description
Thoracic surgery + standard pain management
Arm Title
Abdominal surgery
Arm Type
No Intervention
Arm Description
Abdominal surgery + standard pain management
Arm Title
Spinal surgery
Arm Type
No Intervention
Arm Description
Spinal surgery + standard pain management
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
Erector spinae plane block
Primary Outcome Measure Information:
Title
Visual Analog Pain Score
Description
Reported immediate postoperative VAS score, up to 3rd day
Time Frame
3 days
Title
Total pain med consumption in the PACU
Description
Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU
Time Frame
3 hours
Title
Length of stay in the PACU
Description
Length of stay in postoperative care room
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
30 days
Title
Chronic pain development
Description
Rate of chronic pain at 3 and 6 months after surgery
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all consecutive adult patients who undergo thoracic, spinal or abdominal surgery in Soroka Medical Center, and agree to participate in the study, older than 18 years, who meet criteria of ASA physical status I-II-III-IV class. Exclusion Criteria: Unconscious or mentally incompetent patients or those who refuse to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Natanel, MD
Phone
+972533360451
Email
nataneld@bgu.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Dubilet, MD
Email
michaeldu@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dubilet, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SorokaUMC
City
Beersheba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Natanel, MD
Phone
0533360451
Email
nataneld@bgu.ac.il

12. IPD Sharing Statement

Plan to Share IPD
No

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ESP Block vs. Traditional Pain Management for ERAS

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