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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
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
Soroka Hospital
Beersheba, Israel
RECRUITINGVAS score
the patients reported pain level using the VAS score
Time frame: postoperative - 1 hour
VAS score
the patients reported pain level using the VAS score
Time frame: postoperative - 4 hour
VAS score
the patients reported pain level using the VAS score
Time frame: postoperative - 8 hour
VAS score
the patients reported pain level using the VAS score
Time frame: postoperative - 12 hour
VAS score
the patients reported pain level using the VAS score
Time frame: postoperative - 24 hour
VAS score
the patients reported pain level using the VAS score
Time frame: postoperative - 48 hour
VAS score
the patients reported pain level using the VAS score
Time frame: postoperative - 72 hour
VAS score
the patients reported pain level using the VAS score
Time frame: day 7 postoperative
VAS score
the patients reported pain level using the VAS score
Time frame: day 14 postoperative
VAS score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
the patients reported pain level using the VAS score
Time frame: day 21 postoperative
opioid consumption
total morphine administered (in mg)
Time frame: postoperative - 24 hours
opioid consumption
total morphine administered (in mg)
Time frame: postoperative - 72 hours
heart rate
postoperative heart rate
Time frame: postoperative - 1 hour
heart rate
postoperative heart rate
Time frame: postoperative - 4 hour
heart rate
postoperative heart rate
Time frame: postoperative - 8 hour
heart rate
postoperative heart rate
Time frame: postoperative - 12 hour
heart rate
postoperative heart rate
Time frame: postoperative - 24 hour
blood pressure
postoperative blood pressure - systolic and diastolic
Time frame: postoperative - 1 hour
blood pressure
postoperative blood pressure - systolic and diastolic
Time frame: postoperative - 4 hour
blood pressure
postoperative blood pressure - systolic and diastolic
Time frame: postoperative - 8 hour
blood pressure
postoperative blood pressure - systolic and diastolic
Time frame: postoperative - 12 hour
blood pressure
postoperative blood pressure - systolic and diastolic
Time frame: postoperative - 24 hour
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Time frame: postoperative - 1 hour
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Time frame: postoperative - 4 hour
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Time frame: postoperative - 8 hour
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Time frame: postoperative - 12 hour
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Time frame: postoperative - 24 hour
chronic pain - VAS
patient's self reported current pain score (VAS) over a telephone interview
Time frame: postoperative - 3 months
chronic pain - VAS
patient's self reported current pain score (VAS) over a telephone interview
Time frame: postoperative - 6 months
chronic pain - opioid use
patient's self reported current use of opioids over a telephone interview
Time frame: postoperative - 3 months
chronic pain - opioid use
patient's self reported current use of opioids over a telephone interview
Time frame: postoperative - 6 months
chronic pain - sleep
patient's self reported difficulty sleeping due to pain over a telephone interview
Time frame: postoperative - 3 months
chronic pain - sleep
patient's self reported difficulty sleeping due to pain over a telephone interview
Time frame: postoperative - 6 months