Post Operative PainNCT05512897
Does ESP Block Reduce Pain and Opiates Consumption After Surgery
A study testing erector spinea plane block in people with Post Operative Pain and Regional Anesthesia Morbidity, run by Michael Dubilet MD at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Regional Anesthesia Morbidity, Opioid-Related Disorders
- What is being tested?
- erector spinea plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2020to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing thoracic surgery, older ≥18 years
- Patients who meet criteria of ASA (american society of anesthesiologists) physical status I-II-III class.
Who cannot join
- Patients who will be unconscious or mentally incompetent
- Patients refusal to participate in the study
- ASA -IV -V
- Patient with coagulopathy
- Hemodynamically unstable (systolic blood pressure < 90, heart rate (HR) > 100)
- Allergy to local anesthetic drugs or opioids
- Pregnant patient
- History of opioid abuse
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka Hospital
Beersheba
michael dubilet, md
About this study
Official title: Compared Erector Spinae Plane Block (ESP) Block for Pain Control With Traditional Pain Management Techniques in Patient Undergoing Thoracic and Abdominal Surgery
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
Read the 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
- Being tested
- erector spinea plane block
- Keywords
- erector spinea block, post operative pain, post operative opioid consumption, post operative chronic pain, opioids side effects
- Medical subject headings
- Pain, Postoperative, Opioid-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinea plane blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | standard analgesic treatment |
| standard care + ESP block | Experimental | intraoperativeESP block + standard analgesic treatment Receives: Procedure: erector spinea plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
the patients reported pain level using the VAS score
Measured: postoperative - 1 hour
VAS score
the patients reported pain level using the VAS score
Measured: postoperative - 4 hour
VAS score
the patients reported pain level using the VAS score
Measured: postoperative - 8 hour
VAS score
the patients reported pain level using the VAS score
Measured: postoperative - 12 hour
VAS score
the patients reported pain level using the VAS score
Measured: postoperative - 24 hour
VAS score
the patients reported pain level using the VAS score
Measured: postoperative - 48 hour
VAS score
the patients reported pain level using the VAS score
Measured: postoperative - 72 hour
VAS score
the patients reported pain level using the VAS score
Measured: day 7 postoperative
VAS score
the patients reported pain level using the VAS score
Measured: day 14 postoperative
VAS score
the patients reported pain level using the VAS score
Measured: day 21 postoperative
opioid consumption
total morphine administered (in mg)
Measured: postoperative - 24 hours
opioid consumption
total morphine administered (in mg)
Measured: postoperative - 72 hours
Secondary outcomes (21)
heart rate
postoperative heart rate
Measured: postoperative - 1 hour
heart rate
postoperative heart rate
Measured: postoperative - 4 hour
heart rate
postoperative heart rate
Measured: postoperative - 8 hour
heart rate
postoperative heart rate
Measured: postoperative - 12 hour
heart rate
postoperative heart rate
Measured: postoperative - 24 hour
blood pressure
postoperative blood pressure - systolic and diastolic
Measured: postoperative - 1 hour
blood pressure
postoperative blood pressure - systolic and diastolic
Measured: postoperative - 4 hour
blood pressure
postoperative blood pressure - systolic and diastolic
Measured: postoperative - 8 hour
blood pressure
postoperative blood pressure - systolic and diastolic
Measured: postoperative - 12 hour
blood pressure
postoperative blood pressure - systolic and diastolic
Measured: postoperative - 24 hour
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Measured: postoperative - 1 hour
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Measured: postoperative - 4 hour
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Measured: postoperative - 8 hour
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Measured: postoperative - 12 hour
PONV
post operative nausea and vomiting (PONV) assessed by the PONV impact scale score
Measured: postoperative - 24 hour
chronic pain - VAS
patient's self reported current pain score (VAS) over a telephone interview
Measured: postoperative - 3 months
chronic pain - VAS
patient's self reported current pain score (VAS) over a telephone interview
Measured: postoperative - 6 months
chronic pain - opioid use
patient's self reported current use of opioids over a telephone interview
Measured: postoperative - 3 months
chronic pain - opioid use
patient's self reported current use of opioids over a telephone interview
Measured: postoperative - 6 months
chronic pain - sleep
patient's self reported difficulty sleeping due to pain over a telephone interview
Measured: postoperative - 3 months
chronic pain - sleep
patient's self reported difficulty sleeping due to pain over a telephone interview
Measured: postoperative - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Sep 2020
- Primary completionSep 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to 2 groups - standard care vs standard care+ESP block
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Dubilet MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Dubilet MD, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512897
- Sponsor's protocol ID
- SOR035519CTIL
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compared Erector Spinae Plane Block (ESP) Block for Pain Control With Traditional Pain Management Techniques in Patient Undergoing Thoracic and Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05512897
- Acronym / sponsor ID
- SOR035519CTIL
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Michael Dubilet MDUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to 2 groups - standard care vs standard care+ESP block
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –standard analgesic treatment |
| standard care + ESP block | Experimental | Procedure: erector spinea plane blockintraoperativeESP block + standard analgesic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing thoracic surgery, older ≥18 years
- Patients who meet criteria of ASA (american society of anesthesiologists) physical status I-II-III class.
Key exclusion criteria (8 listed)
- Patients who will be unconscious or mentally incompetent
- Patients refusal to participate in the study
- ASA -IV -V
- Patient with coagulopathy
- Hemodynamically unstable (systolic blood pressure < 90, heart rate (HR) > 100)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erector spinea plane blockin 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 | Procedure or surgery | standard care + ESP block |
Primary outcome
VAS score
Time frame: postoperative - 1 hour
the patients reported pain level using the VAS score
VAS score
Time frame: postoperative - 4 hour
the patients reported pain level using the VAS score
VAS score
Time frame: postoperative - 8 hour
the patients reported pain level using the VAS score
VAS score
Time frame: postoperative - 12 hour
the patients reported pain level using the VAS score
VAS score
Time frame: postoperative - 24 hour
the patients reported pain level using the VAS score
VAS score
Time frame: postoperative - 48 hour
the patients reported pain level using the VAS score
VAS score
Time frame: postoperative - 72 hour
the patients reported pain level using the VAS score
VAS score
Time frame: day 7 postoperative
the patients reported pain level using the VAS score
VAS score
Time frame: day 14 postoperative
the patients reported pain level using the VAS score
VAS score
Time frame: day 21 postoperative
the patients reported pain level using the VAS score
opioid consumption
Time frame: postoperative - 24 hours
total morphine administered (in mg)
opioid consumption
Time frame: postoperative - 72 hours
total morphine administered (in mg)
21 secondary outcomes
heart rate
Time frame: postoperative - 1 hour
heart rate
Time frame: postoperative - 4 hour
heart rate
Time frame: postoperative - 8 hour
heart rate
Time frame: postoperative - 12 hour
heart rate
Time frame: postoperative - 24 hour
blood pressure
Time frame: postoperative - 1 hour
blood pressure
Time frame: postoperative - 4 hour
blood pressure
Time frame: postoperative - 8 hour
blood pressure
Time frame: postoperative - 12 hour
blood pressure
Time frame: postoperative - 24 hour
PONV
Time frame: postoperative - 1 hour
PONV
Time frame: postoperative - 4 hour
PONV
Time frame: postoperative - 8 hour
PONV
Time frame: postoperative - 12 hour
PONV
Time frame: postoperative - 24 hour
chronic pain - VAS
Time frame: postoperative - 3 months
chronic pain - VAS
Time frame: postoperative - 6 months
chronic pain - opioid use
Time frame: postoperative - 3 months
chronic pain - opioid use
Time frame: postoperative - 6 months
chronic pain - sleep
Time frame: postoperative - 3 months
chronic pain - sleep
Time frame: postoperative - 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinea plane block in people with Post Operative Pain and Regional Anesthesia Morbidity, run by Michael Dubilet MD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact michael dubilet, md (972-54-6260728, mikl.dubilet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: postoperative - 1 hour). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.