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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05512897
Other study ID # SOR035519CTIL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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