Pain, PostoperativeNCT04123106
Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration for Perioperative Analgesia in Spine Surgery.
A study testing ESP block and Wound infiltration in people with Pain, Postoperative and SPINAL Fracture, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Postoperative pain still represents an important perioperative issue, affecting more than 80% of patients undergoing surgery. A suboptimal pain management doesn't just affects quality of life, but can compromise rehabilitation plan, increase morbidity and determine the development of chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative, SPINAL Fracture, Spondylolisthesis
- What is being tested?
- ESP block and Wound infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 11 May 2020to 28 Sep 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for lumbar fusion surgery on account of vertebral fractures or degenerative spondylolisthesis.
- Patients consent.
Who cannot join
- Opioid tolerance;
- Documented sleep apnoea or home oxygen therapy;
- History of alcohol or drug abuse;
- Patients with an allergy or hypersensitivity to opioids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Erector Spinae Plane Block (ESP Block) Versus Local Anesthetic (LA) Infiltration for Perioperative Analgesia in Lumbosacral Spine Surgery: a Monocentric Randomized Trial.
Postoperative pain still represents an important perioperative issue, affecting more than 80% of patients undergoing surgery. A suboptimal pain management doesn't just affects quality of life, but can compromise rehabilitation plan, increase morbidity and determine the development of chronic pain. Last but not least, far from being just an obligation for physicians, a good analgesia is a fundamental right of every patient.
In order to meet these important demands, a great number of guidelines has been provided, all of these underlying that the centerpiece of postoperative analgesia lies in the multimodality management, thereby combining different medications and different ways of delivering them, with the aim of targeting distinct receptor systems and improving efficacy, while limiting side effects.
Read more
In 2018, the investigators conducted a case-series analysis on 17 patients undergoing lumbar surgery to find out the role of Sublingual Sufentanil Tablet System (SSTS) in a multimodal analgesia regimen. Patients expressed a good pain relief, with most benefit during physiotherapy sessions and early discharges, in absence of side effects. Since then, SSTS has been part of regular clinical practice in our hospital.
The aim of this randomized trial is to examine the analgesic efficacy and the opioid sparing role in spine surgery of a recently developed regional anesthesia technique, the Erector Spinae Plane block (ESP block), as opposed to Local Anaesthetic (LA) wound infiltration.
The latter is a widespread, simple and unexpensive mean of providing postoperative analgesia. On the other hand, ESP block is an ultrasound-guided interfascial plain block, in which LA is injected below the erector spine muscle, closer to costotransverse foramina and origin of dorsal and ventral rami. It does provide an efficient multidermatomal sensory blockade (according to craniocaudal LA spread), with the advantage of being simple and safe.
- Conditions
- Pain, Postoperative, SPINAL Fracture, Spondylolisthesis
- Being tested
- ESP block, Wound infiltration
- Keywords
- Analgesia, Patient-Controlled, Anesthetics, Local, Pain, Postoperative
- Medical subject headings
- Pain, Postoperative, Spinal Fractures, Spondylolisthesis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP blockProcedure or surgery
ESP block bilaterally performed at the level of the surgical site prior to surgery.
Wound infiltrationProcedure or surgery
Wound infiltration performed at the surgical site at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| ESP block | Experimental | Ultrasound-guided, performed below erector spinae plane (ropivacaine 0.5% 20 mL each side). Receives: Procedure: ESP block |
| Wound infiltration | Active comparator | Ropivacaine 0.5% 20-40 mL, performed by surgeon. Receives: Procedure: Wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) at Post-Anesthesia Care Unit (PACU) arrival
NRS scale is a 11-point scale (0-11), with which patients self-report and rate level of breakthrough pain, where 0 is no pain and 10 the worst pain imaginable.
Measured: At the end of surgery, at PACU arrival.
Secondary outcomes (6)
Difference in Pain Intensity Difference (PID) at PACU arrival, at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival.
PID summarizes treatment response over a clinically relevant period. It represents a raw difference in pain intensity (i.e. the difference between the NRS value at each time point from the NRS at PACU arrival) and it is based on NRS data. It ranges from 0 to 10. The higher the value, the better the pain relief, since the greater is the pain intensity difference.
Measured: At the end of surgery, at PACU arrival; at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival
Difference in Sum of Pain Intensity Difference (SPID) at 12, 24, 48, 72 hours from PACU arrival.
SPID is calculated multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and then summing the values over the relevant time period. SPID represents the sum of the absolute difference in pain intensity. It ranges from 0 to an undefined value, variable according to the time weighted sum. The higher the value, the better the pain relief, since the greater is the pain intensity difference.
Measured: 12 hours, 24 hours, 48 hours, 72 hours from PACU arrival.
Number of Sublingual Sufentanil Tablets taken
All patients eligible will be provided with Sufentanil Sublingual Tablet System.
Measured: 24 hours, 48 hours, 72 hours from PACU arrival.
Safety profile (incidence of adverse events)
Report of any adverse effect (sickness, vomiting, itching, numbness, respiratory side effects, procedure-related complications,..)
Measured: Anytime during the study.
Patients satisfaction
All patients will fill out an Ease-Of-Care (EOC) Questionnaire, highlighting satisfaction with level of pain control and satisfaction with method of administration of pain medication.
Measured: Before discharge, an average of 48 hours from the end of surgery.
Length of hospital stay
Length of hospital stay after surgery
Measured: At discharge, an average of 48 hours from the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start11 May 2020
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Marco Rossi, Dr. Roberta Nestorini, Dr. Mariangela Di Muro
- Responsible party
- Principal investigator, VERGARI ALESSANDRO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123106
- Sponsor's protocol ID
- ESP01
- Status last verified
- Aug 2021
- First submitted
- 21 Sep 2019
- Last updated
- 23 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Erector Spinae Plane Block (ESP Block) Versus Local Anesthetic (LA) Infiltration for Perioperative Analgesia in Lumbosacral Spine Surgery: a Monocentric Randomized Trial.
- ClinicalTrials.gov ID
- NCT04123106
- Acronym / sponsor ID
- ESP01
- Conditions
- Pain, Postoperative, SPINAL Fracture, Spondylolisthesis
- Keywords
- Analgesia, Patient-Controlled, Anesthetics, Local, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Prof. Marco Rossi, Dr. Roberta Nestorini, Dr. Mariangela Di Muro
- Study start
- 11 May 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 10 Oct 2019 (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.
Postoperative pain still represents an important perioperative issue, affecting more than 80% of patients undergoing surgery. A suboptimal pain management doesn't just affects quality of life, but can compromise rehabilitation plan, increase morbidity and determine the development of chronic pain. Last but not least, far from being just an obligation for physicians, a good analgesia is a fundamental right of every patient.
In order to meet these important demands, a great number of guidelines has been provided, all of these underlying that the centerpiece of postoperative analgesia lies in the multimodality management, thereby combining different medications and different ways of delivering them, with the aim of targeting distinct receptor systems and improving efficacy, while limiting side effects.
In 2018, the investigators conducted a case-series analysis on 17 patients undergoing lumbar surgery to find out the role of Sublingual Sufentanil Tablet System (SSTS) in a multimodal analgesia regimen. Patients expressed a good pain relief, with most benefit during physiotherapy sessions and early discharges, in absence of side effects. Since then, SSTS has been part of regular clinical practice in our hospital.
The aim of this randomized trial is to examine the analgesic efficacy and the opioid sparing role in spine surgery of a recently developed regional anesthesia technique, the Erector Spinae Plane block (ESP block), as opposed to Local Anaesthetic (LA) wound infiltration.
The latter is a widespread, simple and unexpensive mean of providing postoperative analgesia. On the other hand, ESP block is an ultrasound-guided interfascial plain block, in which LA is injected below the erector spine muscle, closer to costotransverse foramina and origin of dorsal and ventral rami. It does provide an efficient multidermatomal sensory blockade (according to craniocaudal LA spread), with the advantage of being simple and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP block | Experimental | Procedure: ESP blockUltrasound-guided, performed below erector spinae plane (ropivacaine 0.5% 20 mL each side). |
| Wound infiltration | Active comparator | Procedure: Wound infiltrationRopivacaine 0.5% 20-40 mL, performed by surgeon. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for lumbar fusion surgery on account of vertebral fractures or degenerative spondylolisthesis.
- Patients consent.
Key exclusion criteria (4 listed)
- Opioid tolerance;
- Documented sleep apnoea or home oxygen therapy;
- History of alcohol or drug abuse;
- Patients with an allergy or hypersensitivity to opioids.
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 |
|---|---|---|
| ESP blockESP block bilaterally performed at the level of the surgical site prior to surgery. | Procedure or surgery | ESP block |
| Wound infiltrationWound infiltration performed at the surgical site at the end of surgery. | Procedure or surgery | Wound infiltration |
Primary outcome
Numerical Rating Scale (NRS) at Post-Anesthesia Care Unit (PACU) arrival
Time frame: At the end of surgery, at PACU arrival.
NRS scale is a 11-point scale (0-11), with which patients self-report and rate level of breakthrough pain, where 0 is no pain and 10 the worst pain imaginable.
6 secondary outcomes
Difference in Pain Intensity Difference (PID) at PACU arrival, at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival.
Time frame: At the end of surgery, at PACU arrival; at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival
Difference in Sum of Pain Intensity Difference (SPID) at 12, 24, 48, 72 hours from PACU arrival.
Time frame: 12 hours, 24 hours, 48 hours, 72 hours from PACU arrival.
Number of Sublingual Sufentanil Tablets taken
Time frame: 24 hours, 48 hours, 72 hours from PACU arrival.
Safety profile (incidence of adverse events)
Time frame: Anytime during the study.
Patients satisfaction
Time frame: Before discharge, an average of 48 hours from the end of surgery.
Length of hospital stay
Time frame: At discharge, an average of 48 hours from the end of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP block and Wound infiltration in people with Pain, Postoperative and SPINAL Fracture, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 23 Aug 2021. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) at Post-Anesthesia Care Unit (PACU) arrival (time frame: At the end of surgery, at PACU arrival.). 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 2021.