Does ESP Block Reduce Pain and Opiates Consumption After Surgery

Compared Erector Spinae Plane Block (ESP) Block for Pain Control With Traditional Pain Management Techniques in Patient Undergoing Thoracic and Abdominal Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Opioid-Related Disorders; Post Operative Pain; Regional Anesthesia Morbidity
• Intervention / Treatment: Procedure: erector spinea plane block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: michael dubilet, md; Phone Number: 972-54-6260728; Email: mikl.dubilet@gmail.com

Study Locations

• Israel
  • Be'er Sheva, Israel
    • Recruiting
    • Soroka Hospital
    • Contact: michael dubilet, md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care; standard analgesic treatment
Experimental: standard care + ESP block; intraoperativeESP block + standard analgesic treatment	Procedure: erector spinea plane block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	postoperative heart rate	postoperative - 1 hour
heart rate	postoperative heart rate	postoperative - 4 hour
heart rate	postoperative heart rate	postoperative - 8 hour
heart rate	postoperative heart rate	postoperative - 12 hour
heart rate	postoperative heart rate	postoperative - 24 hour
blood pressure	postoperative blood pressure - systolic and diastolic	postoperative - 1 hour
blood pressure	postoperative blood pressure - systolic and diastolic	postoperative - 4 hour
blood pressure	postoperative blood pressure - systolic and diastolic	postoperative - 8 hour
blood pressure	postoperative blood pressure - systolic and diastolic	postoperative - 12 hour
blood pressure	postoperative blood pressure - systolic and diastolic	postoperative - 24 hour
PONV	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score	postoperative - 1 hour
PONV	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score	postoperative - 4 hour
PONV	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score	postoperative - 8 hour
PONV	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score	postoperative - 12 hour
PONV	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score	postoperative - 24 hour
chronic pain - VAS	patient's self reported current pain score (VAS) over a telephone interview	postoperative - 3 months
chronic pain - VAS	patient's self reported current pain score (VAS) over a telephone interview	postoperative - 6 months
chronic pain - opioid use	patient's self reported current use of opioids over a telephone interview	postoperative - 3 months
chronic pain - opioid use	patient's self reported current use of opioids over a telephone interview	postoperative - 6 months
chronic pain - sleep	patient's self reported difficulty sleeping due to pain over a telephone interview	postoperative - 3 months
chronic pain - sleep	patient's self reported difficulty sleeping due to pain over a telephone interview	postoperative - 6 months

Collaborators and Investigators

• Sponsor: Michael Dubilet MD

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 21, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 21, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: post operative pain; post operative chronic pain; erector spinea block; post operative opioid consumption; opioids side effects
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Pain, Postoperative; Chronic Pain; Opioid-Related Disorders
• Other Study ID Numbers: SOR035519CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No