Postoperative PainPhase 3NCT04299035
ESP Block vs. Traditional Pain Management for ERAS
A Phase 3 study testing Erector spinae plane block in people with Postoperative Pain, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Patients undergoing thoracotomy, thoracoscopy or other surgical procedures involving the integrity of the chest wall are always in a special point of interest of both surgical and anesthesiological specialities. Most of the patients will describe the pain after thoracic surgery as severe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Mar 2020to 5 Sep 2021
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consecutive adult patients who undergo thoracic, spinal or abdominal surgery in Soroka Medical Center, and agree to participate in the study, older than 18 years, who meet criteria of ASA physical status I-II-III-IV class.
Who cannot join
- Unconscious or mentally incompetent patients or those who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
Michael Dubilet, MD contact
Israel1 site, 1 recruiting
- Recruiting
SorokaUMC
Beersheba
Dmitry Natanel, MD, 0533360451, nataneld@bgu.ac.il
About this study
Official title: Erector Spinae Plane Block Versus Traditional Pain Management for Enhanced Recovery After Surgery
Patients undergoing thoracotomy, thoracoscopy or other surgical procedures involving the integrity of the chest wall are always in a special point of interest of both surgical and anesthesiological specialities. Most of the patients will describe the pain after thoracic surgery as severe. It might lead to a number of serious complications: respiratory failure due to splinting; inability to clear secretions by effective coughing, with resulting pneumonia; and turning into a chronic pain: the post-thoracotomy pain syndrome.
Traditional pain management in these groups of patients - such as opiate treatment, thoracic epidural analgesia, and non-opioid drugs - may have serious side effects. Large doses of opiates suppress the cough reflex and lead to respiratory depression with subsequent re-intubation and re-ventilation. Thoracic epidural analgesia, though being considered paramount among other analgesic options, requires a significant clinical experience. Still, it might be insufficient for satisfactory pain control and even complicated with pneumothorax, total spinal anaesthesia and inadvertent intravascular injection. Non-steroidal anti-inflammatory drugs (NSAIDs) and Tramadol are weak analgesics inadequate for severe pain control and might be responsible for gastrointestinal bleeding.
We suggest performing erector spinae plane block for intraoperative and postoperative pain management due to the ease of use and better analgesic effect. What remains is hard proof for the clinical efficacy and safety of this block, followed by a demonstration of the uptake of it in the hands of non-regional anaesthetists.
- Conditions
- Postoperative Pain
- Being tested
- Erector spinae plane block
- Keywords
- Postoperative pain, Erector spinae plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Erector spinae plane block
| Study group | Role | What they receive |
|---|---|---|
| Thoracic surgery + ESPblock | Experimental | Thoracic surgery + ESPblock + standard pain management Receives: Procedure: Erector spinae plane block |
| Abdominal surgery + ESPblock | Experimental | Abdominal surgery + ESPblock + standard pain management Receives: Procedure: Erector spinae plane block |
| Spinal surgery + ESPblock | Experimental | Spinal surgery + ESPblock + standard pain management Receives: Procedure: Erector spinae plane block |
| Thoracic surgery | No intervention | Thoracic surgery + standard pain management |
| Abdominal surgery | No intervention | Abdominal surgery + standard pain management |
| Spinal surgery | No intervention | Spinal surgery + standard pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Score
Reported immediate postoperative VAS score, up to 3rd day
Measured: 3 days
Total pain med consumption in the PACU
Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU
Measured: 3 hours
Length of stay in the PACU
Length of stay in postoperative care room
Measured: 24 hours
Secondary outcomes (2)
Length of hospital stay
Length of hospital stay
Measured: 30 days
Chronic pain development
Rate of chronic pain at 3 and 6 months after surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start5 Mar 2020
- Primary completion5 Mar 2021 (estimated)
- Study completion5 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Natanel MD, Soroka University Medical Center
- Investigators
- Michael Dubilet, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299035
- Sponsor's protocol ID
- 0355-19-SOR
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- 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 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Traditional Pain Management for Enhanced Recovery After Surgery
- ClinicalTrials.gov ID
- NCT04299035
- Acronym / sponsor ID
- 0355-19-SOR
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Erector spinae plane block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 5 Mar 2021 (estimated)
- Study completion
- 5 Sep 2021 (estimated)
- First posted
- 6 Mar 2020 (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.
Patients undergoing thoracotomy, thoracoscopy or other surgical procedures involving the integrity of the chest wall are always in a special point of interest of both surgical and anesthesiological specialities. Most of the patients will describe the pain after thoracic surgery as severe. It might lead to a number of serious complications: respiratory failure due to splinting; inability to clear secretions by effective coughing, with resulting pneumonia; and turning into a chronic pain: the post-thoracotomy pain syndrome.
Traditional pain management in these groups of patients - such as opiate treatment, thoracic epidural analgesia, and non-opioid drugs - may have serious side effects. Large doses of opiates suppress the cough reflex and lead to respiratory depression with subsequent re-intubation and re-ventilation. Thoracic epidural analgesia, though being considered paramount among other analgesic options, requires a significant clinical experience. Still, it might be insufficient for satisfactory pain control and even complicated with pneumothorax, total spinal anaesthesia and inadvertent intravascular injection. Non-steroidal anti-inflammatory drugs (NSAIDs) and Tramadol are weak analgesics inadequate for severe pain control and might be responsible for gastrointestinal bleeding.
We suggest performing erector spinae plane block for intraoperative and postoperative pain management due to the ease of use and better analgesic effect. What remains is hard proof for the clinical efficacy and safety of this block, followed by a demonstration of the uptake of it in the hands of non-regional anaesthetists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Thoracic surgery + ESPblock | Experimental | Procedure: Erector spinae plane blockThoracic surgery + ESPblock + standard pain management |
| Abdominal surgery + ESPblock | Experimental | Procedure: Erector spinae plane blockAbdominal surgery + ESPblock + standard pain management |
| Spinal surgery + ESPblock | Experimental | Procedure: Erector spinae plane blockSpinal surgery + ESPblock + standard pain management |
| Thoracic surgery | No intervention | –Thoracic surgery + standard pain management |
| Abdominal surgery | No intervention | –Abdominal surgery + standard pain management |
| Spinal surgery | No intervention | –Spinal surgery + standard pain management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive adult patients who undergo thoracic, spinal or abdominal surgery in Soroka Medical Center, and agree to participate in the study, older than 18 years, who meet criteria of ASA physical status I-II-III-IV class.
Key exclusion criteria (1 listed)
- Unconscious or mentally incompetent patients or those who refuse to participate in the study.
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 spinae plane blockErector spinae plane block | Procedure or surgery | Abdominal surgery + ESPblock, Spinal surgery + ESPblock, Thoracic surgery + ESPblock |
Primary outcome
Visual Analog Pain Score
Time frame: 3 days
Reported immediate postoperative VAS score, up to 3rd day
Total pain med consumption in the PACU
Time frame: 3 hours
Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU
Length of stay in the PACU
Time frame: 24 hours
Length of stay in postoperative care room
2 secondary outcomes
Length of hospital stay
Time frame: 30 days
Chronic pain development
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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.
Michael Dubilet, MD contact
Michael Dubilet, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erector spinae plane block in people with Postoperative Pain, run by Soroka University Medical Center 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 1 inclusion and 1 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 6 Mar 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dmitry Natanel, MD (+972533360451, nataneld@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Pain Score (time frame: 3 days). The study lists 3 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 6 Mar 2020.