Does ESP Block Reduce Pain and Opiates Consumption After Surgery

NCT ID: NCT05512897

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-02-29

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard care

standard analgesic treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

standard care + ESP block

intraoperativeESP block + standard analgesic treatment

Group Type: EXPERIMENTAL

erector spinea plane block

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michael Dubilet MD

OTHER

Sponsor Role: lead

Responsible Party

Michael Dubilet MD

head of acute pain care unit

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Soroka Hospital

Beersheba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

michael dubilet, md

Role: CONTACT

mikl.dubilet@gmail.com

972-54-6260728

Facility Contacts

michael dubilet, md

Role: primary

Other Identifiers

SOR035519CTIL

Identifier Type: -

Identifier Source: org_study_id