Lumbar Spinal StenosisLumbar-ESPNCT06987409
Continuous Erector Spinae Block for Analgesia Following Lumbar Decompression
A study testing Continuous erector spinae plane block in people with Lumbar Spinal Stenosis and Lumbar Radiculopathy, run by Nova Scotia Health Authority.
Trial summary
Lumbar spinal surgery is common, and the incidence of spinal fusion has increased dramatically over the past three decades. Patients requiring spinal surgery are typically prescribed several analgesics, (including opioids) while awaiting surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Radiculopathy, Persistent Postsurgical Pain
- What is being tested?
- Continuous erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Aug 2028
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (aged >18 years) patients
- Undergoing lumbar decompression surgery +/- fusion
- Under the orthopedic surgery team
Who cannot join
- Surgery on an emergency basis (level 1, 2 or 3; <8 hours)
- An ejection fraction <30%
- Severe pre-existing liver disease (Child B or C)
- Severe kidney disease (Glomerular filtration rate (GFR) <30 (mL/min/1·73m²))
- An allergy to ropivacaine
- Weight <50 kg
- Unable to provide valid consent to study prior to surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Continuous Erector Spinae Block for Analgesia Following Lumbar Decompression: A Randomized Controlled Study
Lumbar spinal surgery is common, and the incidence of spinal fusion has increased dramatically over the past three decades. Patients requiring spinal surgery are typically prescribed several analgesics, (including opioids) while awaiting surgery. Postoperatively, use of high doses of opioids or anti-inflammatory medications have drawbacks. Severe post-operative pain is reported by 45-80% of patients and rates are generally higher in the opioid tolerant patients.
Regional anesthesia (blocking nerves with local anesthetics) works locally, thereby avoiding many side effects associated with other analgesics. One type of nerve block is called erector spinae plane block (ESP). Single injection nerve blocks have been found to decrease pain, nausea, and opioid consumption, while increasing patient satisfaction and quality of recovery. However, these effects only last for 24 hours or less while the worst pain occurs around 36 hours after surgery. Surgeon-placed indwelling catheters could allow infusions of local anesthetics for 54 hours.
Read more
This randomized control trial seeks to assess the effectiveness of surgeon-placed ESP catheters for pain control after lumbar spine surgery.
Hypothesis: Patients receiving a cESP will have less pain, improved quality of recovery, and opioid use following lumbar fusion surgery than those receiving current standard of care pain management.
Methodology: Adult patients undergoing lumbar spine surgery under orthopedic surgery in Halifax will be eligible. The study will include 100 participants, randomly assigned to 2 study arms of 50 participants (1:1 basis to Ropivacaine and placebo groups). At the end of surgery, the surgeon will place the ESP catheters in all study patients under sterile conditions before closing the wound. Ropivacaine 0.5% or normal saline (placebo) 15ml will be injected through each catheter (total 30ml). In the postanesthetic care unit (PACU), two elastomeric pumps will be attached to the ESP catheters. These will be filled with either Ropivacaine 0.2% or normal saline (placebo). The elastomeric pumps are small bottle that patients can carry with them after discharge home. The pumps automatically run at an infusion rate of 10 ml/hr for 54 hours. All patients will also receive the standard of care for pain management for this patient population, which is opioid based with acetaminophen. A quality of recovery (QoR-15) questionnaire will be completed at 72 hours post-operatively. Pain, catheter complication, and opioid use data will be gathered from the patient's charts at 24, 48, and 72 hours post-operatively. At 3- and 6-month follow-ups, patients will complete the Brief Pain Inventory questionnaire. We will analyze differences in pain and opioid consumption at 24, 48, and 72 hours, quality of recovery index scores at 72 hours, postoperative complication rates, and persistent pain at 3 and 6 months.
Read the detailed description
Hypothesis Our hypothesis is that a continuous erector spinae plane block (cESP) is an effective postoperative analgesia for lumbar decompression and interbody fusion patients.
Primary Study Objective To compare pain scores as measured by numeric rating scale (NRS) at 24 hours between continuous erector spinae plane block (cESP) and standard of care with placebo following lumbar fusion surgery.
Main Study Objectives
- To compare the quality of recovery (QoR-15) at 72 hours for patients with a cESP with ropivacaine versus placebo.
- To compare cumulative opioid consumption (in oral morphine equivalents (OME)) between cESP and placebo groups.
- To compare time to discharge from hospital between cESP and placebo groups.
- To compare adverse events between cESP and placebo groups.
- To compare persistent postsurgical pain (PSPP) at 3 months between cESP and placebo.
- Research Plan Subject Selection, Inclusion/exclusion criteria This study will include patients undergoing lumbar decompression and lumbar interbody fusion surgery under orthopedic surgery at the QEII Health Sciences Center in Halifax, Nova Scotia.
Number of participants The study will include a maximum of 100 participants, randomly assigned to 2 study arms of 50 participants. If a participant withdraws from the study and inclusion of their data is not possible, another participant will be recruited to the same study group.
Randomization and concealment Patients who have consented to the study, will be randomly assigned into two groups at the time of the operation, once the procedure has started. A computer-generated random number will be assigned and tracked by the central pharmacy to randomize patients on a 1:1 basis to the Ropivacaine and placebo groups.
The Nova Scotia Health Authority (NSHA) pharmacy will prepare either Ropivacaine 0.2% (2mg/ml) or normal saline in identical elastomeric pumps labelled as "study drug" such that the patient, clinical staff and the researchers are blinded to assigned group.
ESP block procedure - Study Intervention The attending surgeon or fellow will place the erector spinae plane catheters in the operating room. Following decompression +/- fusion of the lumbar spine, two 18g multiholed catheters will be placed under direct vision. A 17g Tuohy needle will be used to tunnel the catheters such that the insertion points are separate from the wound. The tips of the catheters will be placed superficial to the transverse processes, instrumentation, and bone graft of the lumbar spine, as applicable to the procedure. These will be deep to the erector spinae muscles, which will be closed on top of the catheters. The catheters will be secured to the skin using liquid skin adhesive (Dermabond) and a specialized dressing (Epiguard). Local anesthetic will be administered via the catheters after the wound is closed but before the patient emerges from general anesthesia. Ropivacaine 0.5% or normal saline (placebo) 15ml will be injected through each catheter (total 30ml).
Postoperative care In the postanesthetic care unit (PACU), two elastomeric pumps will be attached to the ESP catheters. These will be filled with either Ropivacaine 0.2% or normal saline (placebo). The elastomeric pumps run at an infusion rate of 10ml/hr for 54 hours.
When the patients have met normal PACU discharge criteria they will be transferred to the orthopedics ward. The orthopedics team will determine when the patient is ready for discharge from hospital. Many patients are discharged the following day. If the study patients are discharged prior to the end of the infusion, they would take the elastomeric pump home with them to continue the infusion at home.
All patients in the study will have ESP catheters placed. Other than that, patients will receive all the usual pain medications they normally would in the postoperative period. Patients in the treatment group will be receiving an erector spinae plane block with ropivacaine in addition to usual pain management while patients in the control group will be receiving placebo (saline) via the erector spinae plane catheter in addition to usual pain management.
- Being tested
- Continuous erector spinae plane block
- Keywords
- Erector spinae block, Regional anesthesia
- Medical subject headings
- Spinal Stenosis, Radiculopathy, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous erector spinae plane blockProcedure or surgery
The attending surgeon or fellow will place the erector spinae plane catheters in the operating room. Following decompression +/- fusion of the lumbar spine, catheters will be placed under direct vision. The tips of the catheters will be placed superficial to the transverse processes, instrumentation, and bone graft of the lumbar spine, as applicable to the procedure. These will be deep to the erector spinae muscles, which will be closed on top of the catheters.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane catheter with Ropivacaine | Experimental | All study patients will have two catheters inserted during surgery (i.e. on either side of the spinal cord), but patients in this arm will receive Ropivacaine through the cathedars in addition to normal medications for post-operative pain. Receives: Procedure: Continuous erector spinae plane block |
| Erector spinae plane catheter with normal saline | Placebo comparator | All study patients will have two catheters inserted during surgery (i.e. on either side of the spinal cord), but patients in this arm will receive normal saline (placebo) through the cathedars in addition to normal medications for post-operative pain. Receives: Procedure: Continuous erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS)
Patient rate pain level according to a numbered scale (0-10 with worse pain being rated higher).
Measured: 24 hours
Secondary outcomes (5)
Quality of recovery (QoR-15)
Questionnaire includes five domains of recovery after surgery: patient support, comfort, emotions, physical independence, and pain. Each item is graded on a eleven-point Likert scale with QoR-15 scores ranging from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).
Measured: 72 hours
Cumulative opioid consumption (in oral morphine equivalents (OME))
Quantitative measure of opioid use to be recorded at 24, 48, and 72 hours.
Measured: 72 hours
Time to discharge from hospital
Quantitative measure of the hours between surgery and discharge.
Measured: Up to 30 days
Adverse events
Includes recording of postoperative nausea and vomiting (PONV), pneumonia, respiratory failure, wound infection, sepsis, arrhythmias, readmission to hospital within 30 days, and hospital mortality.
Measured: 30 days
Persistent postsurgical pain (PSPP)
Based on the Brief Pain Inventory. Average pain in the prior 24 hours will be rated on a scale from 0-10 with worse pain being rated higher.
Measured: 3 months and 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 May 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- In this trial, the investigators are investigating the efficacy of using a continuous erector spinae plane block that delivers Ropivacaine (compared to normal saline (placebo)) for managing post-operative pain following spine surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987409
- Sponsor's protocol ID
- REB 56541
- Acronym
- Lumbar-ESP
- Status last verified
- Jan 2026
- First submitted
- 23 Aug 2024
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Erector Spinae Block for Analgesia Following Lumbar Decompression: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06987409
- Acronym / sponsor ID
- Lumbar-ESP / REB 56541
- Keywords
- Erector spinae block, Regional anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 23 May 2025 (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.
Lumbar spinal surgery is common, and the incidence of spinal fusion has increased dramatically over the past three decades. Patients requiring spinal surgery are typically prescribed several analgesics, (including opioids) while awaiting surgery. Postoperatively, use of high doses of opioids or anti-inflammatory medications have drawbacks. Severe post-operative pain is reported by 45-80% of patients and rates are generally higher in the opioid tolerant patients.
Regional anesthesia (blocking nerves with local anesthetics) works locally, thereby avoiding many side effects associated with other analgesics. One type of nerve block is called erector spinae plane block (ESP). Single injection nerve blocks have been found to decrease pain, nausea, and opioid consumption, while increasing patient satisfaction and quality of recovery. However, these effects only last for 24 hours or less while the worst pain occurs around 36 hours after surgery. Surgeon-placed indwelling catheters could allow infusions of local anesthetics for 54 hours.
This randomized control trial seeks to assess the effectiveness of surgeon-placed ESP catheters for pain control after lumbar spine surgery.
Hypothesis: Patients receiving a cESP will have less pain, improved quality of recovery, and opioid use following lumbar fusion surgery than those receiving current standard of care pain management.
Methodology: Adult patients undergoing lumbar spine surgery under orthopedic surgery in Halifax will be eligible. The study will include 100 participants, randomly assigned to 2 study arms of 50 participants (1:1 basis to Ropivacaine and placebo groups). At the end of surgery, the surgeon will place the ESP catheters in all study patients under sterile conditions before closing the wound. Ropivacaine 0.5% or normal saline (placebo) 15ml will be injected through each catheter (total 30ml). In the postanesthetic care unit (PACU), two elastomeric pumps will be attached to the ESP catheters. These will be filled with either Ropivacaine 0.2% or normal saline (placebo). The elastomeric pumps are small bottle that patients can carry with them after discharge home. The pumps automatically run at an infusion rate of 10 ml/hr for 54 hours. All patients will also receive the standard of care for pain management for this patient population, which is opioid based with acetaminophen. A quality of recovery (QoR-15) questionnaire will be completed at 72 hours post-operatively. Pain, catheter complication, and opioid use data will be gathered from the patient's charts at 24, 48, and 72 hours post-operatively. At 3- and 6-month follow-ups, patients will complete the Brief Pain Inventory questionnaire. We will analyze differences in pain and opioid consumption at 24, 48, and 72 hours, quality of recovery index scores at 72 hours, postoperative complication rates, and persistent pain at 3 and 6 months.
Detailed description
Hypothesis Our hypothesis is that a continuous erector spinae plane block (cESP) is an effective postoperative analgesia for lumbar decompression and interbody fusion patients.
Primary Study Objective To compare pain scores as measured by numeric rating scale (NRS) at 24 hours between continuous erector spinae plane block (cESP) and standard of care with placebo following lumbar fusion surgery.
Main Study Objectives
- To compare the quality of recovery (QoR-15) at 72 hours for patients with a cESP with ropivacaine versus placebo.
- To compare cumulative opioid consumption (in oral morphine equivalents (OME)) between cESP and placebo groups.
- To compare time to discharge from hospital between cESP and placebo groups.
- To compare adverse events between cESP and placebo groups.
- To compare persistent postsurgical pain (PSPP) at 3 months between cESP and placebo.
- Research Plan Subject Selection, Inclusion/exclusion criteria This study will include patients undergoing lumbar decompression and lumbar interbody fusion surgery under orthopedic surgery at the QEII Health Sciences Center in Halifax, Nova Scotia.
Number of participants The study will include a maximum of 100 participants, randomly assigned to 2 study arms of 50 participants. If a participant withdraws from the study and inclusion of their data is not possible, another participant will be recruited to the same study group.
Randomization and concealment Patients who have consented to the study, will be randomly assigned into two groups at the time of the operation, once the procedure has started. A computer-generated random number will be assigned and tracked by the central pharmacy to randomize patients on a 1:1 basis to the Ropivacaine and placebo groups.
The Nova Scotia Health Authority (NSHA) pharmacy will prepare either Ropivacaine 0.2% (2mg/ml) or normal saline in identical elastomeric pumps labelled as "study drug" such that the patient, clinical staff and the researchers are blinded to assigned group.
ESP block procedure - Study Intervention The attending surgeon or fellow will place the erector spinae plane catheters in the operating room. Following decompression +/- fusion of the lumbar spine, two 18g multiholed catheters will be placed under direct vision. A 17g Tuohy needle will be used to tunnel the catheters such that the insertion points are separate from the wound. The tips of the catheters will be placed superficial to the transverse processes, instrumentation, and bone graft of the lumbar spine, as applicable to the procedure. These will be deep to the erector spinae muscles, which will be closed on top of the catheters. The catheters will be secured to the skin using liquid skin adhesive (Dermabond) and a specialized dressing (Epiguard). Local anesthetic will be administered via the catheters after the wound is closed but before the patient emerges from general anesthesia. Ropivacaine 0.5% or normal saline (placebo) 15ml will be injected through each catheter (total 30ml).
Postoperative care In the postanesthetic care unit (PACU), two elastomeric pumps will be attached to the ESP catheters. These will be filled with either Ropivacaine 0.2% or normal saline (placebo). The elastomeric pumps run at an infusion rate of 10ml/hr for 54 hours.
When the patients have met normal PACU discharge criteria they will be transferred to the orthopedics ward. The orthopedics team will determine when the patient is ready for discharge from hospital. Many patients are discharged the following day. If the study patients are discharged prior to the end of the infusion, they would take the elastomeric pump home with them to continue the infusion at home.
All patients in the study will have ESP catheters placed. Other than that, patients will receive all the usual pain medications they normally would in the postoperative period. Patients in the treatment group will be receiving an erector spinae plane block with ropivacaine in addition to usual pain management while patients in the control group will be receiving placebo (saline) via the erector spinae plane catheter in addition to usual pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this trial, the investigators are investigating the efficacy of using a continuous erector spinae plane block that delivers Ropivacaine (compared to normal saline (placebo)) for managing post-operative pain following spine surgery.
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane catheter with Ropivacaine | Experimental | Procedure: Continuous erector spinae plane blockAll study patients will have two catheters inserted during surgery (i.e. on either side of the spinal cord), but patients in this arm will receive Ropivacaine through the cathedars in addition to normal medications for post-operative pain. |
| Erector spinae plane catheter with normal saline | Placebo comparator | Procedure: Continuous erector spinae plane blockAll study patients will have two catheters inserted during surgery (i.e. on either side of the spinal cord), but patients in this arm will receive normal saline (placebo) through the cathedars in addition to normal medications for post-operative pain. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (aged >18 years) patients
- Undergoing lumbar decompression surgery +/- fusion
- Under the orthopedic surgery team
Key exclusion criteria (7 listed)
- Surgery on an emergency basis (level 1, 2 or 3; <8 hours)
- An ejection fraction <30%
- Severe pre-existing liver disease (Child B or C)
- Severe kidney disease (Glomerular filtration rate (GFR) <30 (mL/min/1·73m²))
- An allergy to ropivacaine
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 |
|---|---|---|
| Continuous erector spinae plane blockThe attending surgeon or fellow will place the erector spinae plane catheters in the operating room. Following decompression +/- fusion of the lumbar spine, catheters will be placed under direct vision. The tips of the catheters will be placed superficial to the transverse processes, instrumentation, and bone graft of the lumbar spine, as applicable to the procedure. These will be deep to the erector spinae muscles, which will be closed on top of the catheters. | Procedure or surgery | Erector spinae plane catheter with Ropivacaine, Erector spinae plane catheter with normal saline |
Primary outcome
Numeric rating scale (NRS)
Time frame: 24 hours
Patient rate pain level according to a numbered scale (0-10 with worse pain being rated higher).
5 secondary outcomes
Quality of recovery (QoR-15)
Time frame: 72 hours
Cumulative opioid consumption (in oral morphine equivalents (OME))
Time frame: 72 hours
Time to discharge from hospital
Time frame: Up to 30 days
Adverse events
Time frame: 30 days
Persistent postsurgical pain (PSPP)
Time frame: 3 months and 6 months
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 17 Feb 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous erector spinae plane block in people with Lumbar Spinal Stenosis and Lumbar Radiculopathy, run by Nova Scotia Health Authority.
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 3 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Jonathan Bailey, MD (902-473-2331, jon.bailey@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) (time frame: 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 17 Feb 2026.