Does ESP Block Reduce Pain and Opiates Consumption After Surgery

Sponsor

Michael Dubilet MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT05512897

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Regional Anesthesia Morbidity Opioid-Related Disorders Chronic Pain	Procedure: erector spinea plane block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized to 2 groups - standard care vs standard care+ESP blockPatients will be randomized to 2 groups - standard care vs standard care+ESP block

Masking:

Single (Participant)

Masking Description:

The block will be preformed under anesthesia. The patients will not know what intervention group they are allocated

Primary Purpose:

Treatment

Official Title:

Compared Erector Spinae Plane Block (ESP) Block for Pain Control With Traditional Pain Management Techniques in Patient Undergoing Thoracic and Abdominal Surgery

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: standard care standard analgesic treatment
Experimental: standard care + ESP block intraoperativeESP block + standard analgesic treatment	Procedure: 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

Arm

Intervention/Treatment

No Intervention: standard care

standard analgesic treatment

Experimental: standard care + ESP block

intraoperativeESP block + standard analgesic treatment

Procedure: 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

Outcome Measures

Primary Outcome Measures

VAS score [postoperative - 1 hour]
the patients reported pain level using the VAS score
VAS score [postoperative - 4 hour]
the patients reported pain level using the VAS score
VAS score [postoperative - 8 hour]
the patients reported pain level using the VAS score
VAS score [postoperative - 12 hour]
the patients reported pain level using the VAS score
VAS score [postoperative - 24 hour]
the patients reported pain level using the VAS score
VAS score [postoperative - 48 hour]
the patients reported pain level using the VAS score
VAS score [postoperative - 72 hour]
the patients reported pain level using the VAS score
VAS score [day 7 postoperative]
the patients reported pain level using the VAS score
VAS score [day 14 postoperative]
the patients reported pain level using the VAS score
VAS score [day 21 postoperative]
the patients reported pain level using the VAS score
opioid consumption [postoperative - 24 hours]
total morphine administered (in mg)
opioid consumption [postoperative - 72 hours]
total morphine administered (in mg)

Secondary Outcome Measures

heart rate [postoperative - 1 hour]
postoperative heart rate
heart rate [postoperative - 4 hour]
postoperative heart rate
heart rate [postoperative - 8 hour]
postoperative heart rate
heart rate [postoperative - 12 hour]
postoperative heart rate
heart rate [postoperative - 24 hour]
postoperative heart rate
blood pressure [postoperative - 1 hour]
postoperative blood pressure - systolic and diastolic
blood pressure [postoperative - 4 hour]
postoperative blood pressure - systolic and diastolic
blood pressure [postoperative - 8 hour]
postoperative blood pressure - systolic and diastolic
blood pressure [postoperative - 12 hour]
postoperative blood pressure - systolic and diastolic
blood pressure [postoperative - 24 hour]
postoperative blood pressure - systolic and diastolic
PONV [postoperative - 1 hour]
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
PONV [postoperative - 4 hour]
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
PONV [postoperative - 8 hour]
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
PONV [postoperative - 12 hour]
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
PONV [postoperative - 24 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
chronic pain - VAS [postoperative - 6 months]
patient's self reported current pain score (VAS) over a telephone interview
chronic pain - opioid use [postoperative - 3 months]
patient's self reported current use of opioids over a telephone interview
chronic pain - opioid use [postoperative - 6 months]
patient's self reported current use of opioids over a telephone interview
chronic pain - sleep [postoperative - 3 months]
patient's self reported difficulty sleeping due to pain over a telephone interview
chronic pain - sleep [postoperative - 6 months]
patient's self reported difficulty sleeping due to pain over a telephone interview

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All patients undergoing thoracic surgery, older ≥18 years
Patients who meet criteria of ASA (american society of anesthesiologists) physical status I-II-III class.