Pain, PostoperativeNCT05271331
ESP Block Versus Wound Infiltration for Laminectomy
A study testing ESP block with saline, Wound infiltration with saline and ESP block with local anesthetic in people with Pain, Postoperative and Opioid Use, run by University of Padova at 1 site in Italy.
Trial summary
Spinal surgery is often burdened by perioperative pain and its treatment presently represents a challenge for anesthetists. An inadequate intra and postoperative analgesic therapy leads to a delay in the mobilization of the patients, prolonged hospital stay and thromboembolic complications, as well as the onset of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Opioid Use, Anesthesia, Local
- What is being tested?
- ESP block with saline, Wound infiltration with saline and ESP block with local anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2022to 20 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- -Planned 1 or 2 level surgical laminectomy
Who cannot join
- Allergy to local anesthetics
- Refusal of consent
- Uncompensated cardiopathies, nephropathies, liver disease or peripheral neuropathies
- Hemopathies that predispose to bleeding
- Gastrointestinal ulcer or bleeding
- Local infection
- Psychiatric or neurological disorders (except those attributed to primary disease for which intervention is planned) History of abuse (or use in the 24 hours prior to surgery) Alcohol addiction ASA > 3
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Padova
Padova, Veneto, 35127
Alessandro De Cassai, MD
About this study
Official title: ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial
Spinal surgery is often burdened by perioperative pain and its treatment presently represents a challenge for anesthetists. An inadequate intra and postoperative analgesic therapy leads to a delay in the mobilization of the patients, prolonged hospital stay and thromboembolic complications, as well as the onset of chronic pain syndromes . Effective pain treatment can help improve surgical outcome for patients undergoing spinal surgery. From the pathophysiological point of view pain in vertebral surgery can originate from different anatomical structures: vertebrae, discs, ligaments, dura mater, facet joints, muscles and skin-subcutis. The terminal innervation of these tissues originate from the dorsal branches of the spinal nerves, and this represents a target a multimodal approach to perioperative analgesia in vertebral surgery. Systemically administered drugs such as NSAIDs, opioids, ketamine, intravenous lidocaine could benefit from the addition of locoregional therapies such as neuraxial blocks (anesthesia peridural or subarachnoid) or as shown more recently by other anesthesia techniques locoregional ultrasound-guided In recent years the anesthesiological interest has focused on the Erector Spinae Plane Block (ESPB). First described by Forero et al, it is a paraspinal interfascial block targeting the dorsal and ventral branches of the spinal nerves just after their emergence from the spinal cord. In the ultrasound-guided technique the local anesthetic is injected between the deep fascia of the muscle itself and the transverse processes of the vertebrae at the level interested. The aim of this study is to evaluate the efficacy of ESPB when compared to wound infiltration in patients undergoing laminectomy
- Conditions
- Pain, Postoperative, Opioid Use, Anesthesia, Local, Surgery
- Being tested
- ESP block with saline, Wound infiltration with saline, ESP block with local anesthetic, Wound infiltration with local anesthetic
- Keywords
- ESP block, Laminectomy, Wound infiltration
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP block with salineDrug
Also called Erector spinae plane block
Bilateral ultrasound guided injection of saline in the erector spinae plane (below erector spinae plane muscle group and above the transverse process of the vertebra)
Wound infiltration with salineDrug
Blinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision
ESP block with local anestheticDrug
Also called Erector spinae plane block
Bilateral ultrasound guided injection of local anesthetic (ropivacaine 0.35%, 40ml) in the erector spinae plane (below erector spinae plane muscle group and above the tranverse process of the vertebra)
Wound infiltration with local anestheticDrug
Blinded injection of local anestetic (ropivacaine 0.35%, 40ml) in the skin, subcutaneous tissue and muscles at the site of surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| ESP block | Experimental | Patient will receive ESP block one level above surgery with ropivacaine 0.35% 20 ml per side Patient will receive preoperative wound infiltration with Saline 40 ml Receives: Drug: Wound infiltration with saline; Drug: ESP block with local anesthetic |
| Wound infiltration | Active comparator | Patient will receive ESP block one level above surgery with Saline 20 ml per side Patient will receive preoperative wound infiltration with ropivacaine 0.35% 40 ml Receives: Drug: ESP block with saline; Drug: Wound infiltration with local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tramadol consumption
Postoperative tramadol consumption
Measured: Evaluated from extubation for the first post-operative 24 hours
Secondary outcomes (11)
Pain 0 hours
Pain measured with Numeric Rating Scale (0-10)
Measured: At extubation
Pain 6 hours
Pain measured with Numeric Rating Scale (0-10)
Measured: 6 hours after end of surgery
Pain 12 hours
Pain measured with Numeric Rating Scale (0-10)
Measured: 12 hours after end of surgery
Pain 24 hours
Pain measured with Numeric Rating Scale (0-10)
Measured: 24 hours after end of surgery
Time to first analgesic requirement
Time in minutes to first analgesic requirement
Measured: 24 hours after end of surgery
Incidence of post operative nausea-vomiting
Incidence of post operative nausea-vomiting
Measured: 24 hours after end of surgery
Incidence of post operative respiratory depression
Incidence of post operative respiratory depression
Measured: 24 hours after end of surgery
Incidence of post operative pruritus
Incidence of post operative pruritus
Measured: 24 hours after end of surgery
Incidence of post operative motor block
Incidence of post operative motor block
Measured: 24 hours after end of surgery
Intraoperative opioid consumption
Intraoperative difference in consumption of fentanyl.
Measured: At extubation
Evaluation of patient satisfaction
Evaluation of patient satisfaction of analgesia on a numeric rating score from 0-10.
Measured: 24 hours after 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 posted9 Mar 2022
- Study start23 May 2022
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Geraldini, University of Padova
- Investigators
- Federico Geraldini, MD, Principal investigator, University Hospital of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271331
- Sponsor's protocol ID
- 5211/AO/21
- Status last verified
- Apr 2025
- First submitted
- 23 Feb 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared on reasonable request after ethical committee request examination
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05271331
- Acronym / sponsor ID
- 5211/AO/21
- Conditions
- Pain, Postoperative, Opioid Use, Anesthesia, Local, Surgery
- Keywords
- ESP block, Laminectomy, Wound infiltration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 9 Mar 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.
Spinal surgery is often burdened by perioperative pain and its treatment presently represents a challenge for anesthetists. An inadequate intra and postoperative analgesic therapy leads to a delay in the mobilization of the patients, prolonged hospital stay and thromboembolic complications, as well as the onset of chronic pain syndromes . Effective pain treatment can help improve surgical outcome for patients undergoing spinal surgery. From the pathophysiological point of view pain in vertebral surgery can originate from different anatomical structures: vertebrae, discs, ligaments, dura mater, facet joints, muscles and skin-subcutis. The terminal innervation of these tissues originate from the dorsal branches of the spinal nerves, and this represents a target a multimodal approach to perioperative analgesia in vertebral surgery. Systemically administered drugs such as NSAIDs, opioids, ketamine, intravenous lidocaine could benefit from the addition of locoregional therapies such as neuraxial blocks (anesthesia peridural or subarachnoid) or as shown more recently by other anesthesia techniques locoregional ultrasound-guided In recent years the anesthesiological interest has focused on the Erector Spinae Plane Block (ESPB). First described by Forero et al, it is a paraspinal interfascial block targeting the dorsal and ventral branches of the spinal nerves just after their emergence from the spinal cord. In the ultrasound-guided technique the local anesthetic is injected between the deep fascia of the muscle itself and the transverse processes of the vertebrae at the level interested. The aim of this study is to evaluate the efficacy of ESPB when compared to wound infiltration in patients undergoing laminectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP block | Experimental | Drug: Wound infiltration with saline, Drug: ESP block with local anestheticPatient will receive ESP block one level above surgery with ropivacaine 0.35% 20 ml per side Patient will receive preoperative wound infiltration with Saline 40 ml |
| Wound infiltration | Active comparator | Drug: ESP block with saline, Drug: Wound infiltration with local anestheticPatient will receive ESP block one level above surgery with Saline 20 ml per side Patient will receive preoperative wound infiltration with ropivacaine 0.35% 40 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Planned 1 or 2 level surgical laminectomy
Key exclusion criteria (7 listed)
- Allergy to local anesthetics
- Refusal of consent
- Uncompensated cardiopathies, nephropathies, liver disease or peripheral neuropathies
- Hemopathies that predispose to bleeding
- Gastrointestinal ulcer or bleeding
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 block with salineAlso: Erector spinae plane blockBilateral ultrasound guided injection of saline in the erector spinae plane (below erector spinae plane muscle group and above the transverse process of the vertebra) | Drug | Wound infiltration |
| Wound infiltration with salineBlinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision | Drug | ESP block |
| ESP block with local anestheticAlso: Erector spinae plane blockBilateral ultrasound guided injection of local anesthetic (ropivacaine 0.35%, 40ml) in the erector spinae plane (below erector spinae plane muscle group and above the tranverse process of the vertebra) | Drug | ESP block |
| Wound infiltration with local anestheticBlinded injection of local anestetic (ropivacaine 0.35%, 40ml) in the skin, subcutaneous tissue and muscles at the site of surgical incision. | Drug | Wound infiltration |
Primary outcome
Tramadol consumption
Time frame: Evaluated from extubation for the first post-operative 24 hours
Postoperative tramadol consumption
11 secondary outcomes
Pain 0 hours
Time frame: At extubation
Pain 6 hours
Time frame: 6 hours after end of surgery
Pain 12 hours
Time frame: 12 hours after end of surgery
Pain 24 hours
Time frame: 24 hours after end of surgery
Time to first analgesic requirement
Time frame: 24 hours after end of surgery
Incidence of post operative nausea-vomiting
Time frame: 24 hours after end of surgery
Incidence of post operative respiratory depression
Time frame: 24 hours after end of surgery
Incidence of post operative pruritus
Time frame: 24 hours after end of surgery
Incidence of post operative motor block
Time frame: 24 hours after end of surgery
Intraoperative opioid consumption
Time frame: At extubation
Evaluation of patient satisfaction
Time frame: 24 hours after end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Undecided. IPD will be shared on reasonable request after ethical committee request examination
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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.
Federico Geraldini, MD principal investigator
University Hospital of Padova
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 with saline, Wound infiltration with saline and ESP block with local anesthetic in people with Pain, Postoperative and Opioid Use, run by University of Padova 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro De Cassai (+390498213090, alessandro.decassai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tramadol consumption (time frame: Evaluated from extubation for the first post-operative 24 hours). 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 26 Jun 2025.