Chronic Pain, Opioid-Related Disorders, Post Operative Pain, Regional Anesthesia Morbidity
Conditions
Keywords
erector spinea block, post operative pain, post operative opioid consumption, post operative chronic pain, opioids side effects
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.
Interventions
PROCEDUREerector 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
Sponsors
Michael Dubilet MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The block will be preformed under anesthesia. The patients will not know what intervention group they are allocated
Intervention model description
Patients will be randomized to 2 groups - standard care vs standard care+ESP block
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS score | postoperative - 1 hour | the patients reported pain level using the VAS score |
| opioid consumption | postoperative - 24 hours | total morphine administered (in mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PONV | postoperative - 1 hour | post operative nausea and vomiting (PONV) assessed by the PONV impact scale score |
| chronic pain - VAS | postoperative - 3 months | patient's self reported current pain score (VAS) over a telephone interview |
| heart rate | postoperative - 1 hour | postoperative heart rate |
| chronic pain - sleep | postoperative - 3 months | patient's self reported difficulty sleeping due to pain over a telephone interview |
| chronic pain - opioid use | postoperative - 3 months | patient's self reported current use of opioids over a telephone interview |
| blood pressure | postoperative - 1 hour | postoperative blood pressure - systolic and diastolic |
Countries
Israel
Contacts
Primary Contactmichael dubilet, md
Outcome results
None listed