Does ESP Block Reduce Pain and Opiates Consumption After Surgery

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05512897
• Other study ID #: SOR035519CTIL
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: February 2024

Study information

• Verified date: August 2022
• Source: Soroka University Medical Center
• Contact: michael dubilet, md
• Phone: 972-54-6260728
• Email: mikl.dubilet[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid-Related Disorders
• Pain, Postoperative
• Post Operative Pain
• Regional Anesthesia Morbidity

Intervention

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

Locations

Country	Name	City	State
Israel	Soroka Hospital	Be'er Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Michael Dubilet MD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS score	the patients reported pain level using the VAS score	postoperative - 1 hour
Primary	VAS score	the patients reported pain level using the VAS score	postoperative - 4 hour
Primary	VAS score	the patients reported pain level using the VAS score	postoperative - 8 hour
Primary	VAS score	the patients reported pain level using the VAS score	postoperative - 12 hour
Primary	VAS score	the patients reported pain level using the VAS score	postoperative - 24 hour
Primary	VAS score	the patients reported pain level using the VAS score	postoperative - 48 hour
Primary	VAS score	the patients reported pain level using the VAS score	postoperative - 72 hour
Primary	VAS score	the patients reported pain level using the VAS score	day 7 postoperative
Primary	VAS score	the patients reported pain level using the VAS score	day 14 postoperative
Primary	VAS score	the patients reported pain level using the VAS score	day 21 postoperative
Primary	opioid consumption	total morphine administered (in mg)	postoperative - 24 hours
Primary	opioid consumption	total morphine administered (in mg)	postoperative - 72 hours
Secondary	heart rate	postoperative heart rate	postoperative - 1 hour
Secondary	heart rate	postoperative heart rate	postoperative - 4 hour
Secondary	heart rate	postoperative heart rate	postoperative - 8 hour
Secondary	heart rate	postoperative heart rate	postoperative - 12 hour
Secondary	heart rate	postoperative heart rate	postoperative - 24 hour
Secondary	blood pressure	postoperative blood pressure - systolic and diastolic	postoperative - 1 hour
Secondary	blood pressure	postoperative blood pressure - systolic and diastolic	postoperative - 4 hour
Secondary	blood pressure	postoperative blood pressure - systolic and diastolic	postoperative - 8 hour
Secondary	blood pressure	postoperative blood pressure - systolic and diastolic	postoperative - 12 hour
Secondary	blood pressure	postoperative blood pressure - systolic and diastolic	postoperative - 24 hour
Secondary	PONV	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score	postoperative - 1 hour
Secondary	PONV	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score	postoperative - 4 hour
Secondary	PONV	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score	postoperative - 8 hour
Secondary	PONV	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score	postoperative - 12 hour
Secondary	PONV	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score	postoperative - 24 hour
Secondary	chronic pain - VAS	patient's self reported current pain score (VAS) over a telephone interview	postoperative - 3 months
Secondary	chronic pain - VAS	patient's self reported current pain score (VAS) over a telephone interview	postoperative - 6 months
Secondary	chronic pain - opioid use	patient's self reported current use of opioids over a telephone interview	postoperative - 3 months
Secondary	chronic pain - opioid use	patient's self reported current use of opioids over a telephone interview	postoperative - 6 months
Secondary	chronic pain - sleep	patient's self reported difficulty sleeping due to pain over a telephone interview	postoperative - 3 months
Secondary	chronic pain - sleep	patient's self reported difficulty sleeping due to pain over a telephone interview	postoperative - 6 months