Clinical trial NCT05512897: Does ESP Block Reduce Pain and Opiates Consumption After Surgery
Official title: Compared Erector Spinae Plane Block (ESP) Block for Pain Control With Traditional Pain Management Techniques in Patient Undergoing Thoracic and Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Regional Anesthesia Morbidity
Opioid-Related Disorders
Chronic Pain
Keywords: erector spinea block
post operative pain
post operative opioid consumption
post operative chronic pain
opioids side effects
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to 2 groups - standard care vs standard care+ESP block
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS score
timeFrame: postoperative - 1 hour
measure: VAS score
timeFrame: postoperative - 4 hour
measure: VAS score
timeFrame: postoperative - 8 hour
measure: VAS score
timeFrame: postoperative - 12 hour
measure: VAS score
timeFrame: postoperative - 24 hour
measure: VAS score
timeFrame: postoperative - 48 hour
measure: VAS score
timeFrame: postoperative - 72 hour
measure: VAS score
timeFrame: day 7 postoperative
measure: VAS score
timeFrame: day 14 postoperative
measure: VAS score
timeFrame: day 21 postoperative
measure: opioid consumption
timeFrame: postoperative - 24 hours
measure: opioid consumption
timeFrame: postoperative - 72 hours
Secondary outcomes:
measure: heart rate
timeFrame: postoperative - 1 hour
measure: heart rate
timeFrame: postoperative - 4 hour
measure: heart rate
timeFrame: postoperative - 8 hour
measure: heart rate
timeFrame: postoperative - 12 hour
measure: heart rate
timeFrame: postoperative - 24 hour
measure: blood pressure
timeFrame: postoperative - 1 hour
measure: blood pressure
timeFrame: postoperative - 4 hour
measure: blood pressure
timeFrame: postoperative - 8 hour
measure: blood pressure
timeFrame: postoperative - 12 hour
measure: blood pressure
timeFrame: postoperative - 24 hour
measure: PONV
timeFrame: postoperative - 1 hour
measure: PONV
timeFrame: postoperative - 4 hour
measure: PONV
timeFrame: postoperative - 8 hour
measure: PONV
timeFrame: postoperative - 12 hour
measure: PONV
timeFrame: postoperative - 24 hour
measure: chronic pain - VAS
timeFrame: postoperative - 3 months
measure: chronic pain - VAS
timeFrame: postoperative - 6 months
measure: chronic pain - opioid use
timeFrame: postoperative - 3 months
measure: chronic pain - opioid use
timeFrame: postoperative - 6 months
measure: chronic pain - sleep
timeFrame: postoperative - 3 months
measure: chronic pain - sleep
timeFrame: postoperative - 6 months
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka Hospital
Study officials:
References: