Does ESP Block Reduce Pain and Opiates Consumption After Surgery

Not Applicable

• Conditions: Regional Anesthesia Morbidity; Post Operative Pain; Opioid-Related Disorders; Chronic Pain

• Registration Number: NCT05512897
• Lead Sponsor: Michael Dubilet MD

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.

Study Timeline

• Study Start: 2020-09-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-21
• Last Update Submitted: 2022-08-21
• Study First Posted: 2022-08-23
• Last Update Posted: 2022-08-23
• Primary Completion: 2023-09
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS score	day 21 postoperative	the patients reported pain level using the VAS score
opioid consumption	postoperative - 72 hours	total morphine administered (in mg)

Secondary Outcome Measures

Name	Time	Method
blood pressure	postoperative - 24 hour	postoperative blood pressure - systolic and diastolic
chronic pain - sleep	postoperative - 6 months	patient's self reported difficulty sleeping due to pain over a telephone interview
heart rate	postoperative - 24 hour	postoperative heart rate
PONV	postoperative - 24 hour	post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
chronic pain - opioid use	postoperative - 6 months	patient's self reported current use of opioids over a telephone interview
chronic pain - VAS	postoperative - 6 months	patient's self reported current pain score (VAS) over a telephone interview

Trial Locations

Locations (1)

Soroka Hospital; 🇮🇱 Be'er Sheva, Israel