An interventional study of Continuous erector spinae plane block in Lumbar Spinal Stenosis, Lumbar Radiculopathy and Persistent Postsurgical Pain, sponsored by Nova Scotia Health Authority. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Treatment
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.
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
1. 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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Nova Scotia Health Authority is the lead sponsor of 264 studies on the registry; 79 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Continuous erector spinae plane block
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.
Procedure: Continuous erector spinae plane block
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.
Numeric rating scale (NRS)
Patient rate pain level according to a numbered scale (0-10 with worse pain being rated higher).
Time frame: 24 hours
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).
Time frame: 72 hours
Cumulative opioid consumption (in oral morphine equivalents (OME))
Quantitative measure of opioid use to be recorded at 24, 48, and 72 hours.
Time frame: 72 hours
Time to discharge from hospital
Quantitative measure of the hours between surgery and discharge.
Time frame: 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.
Time frame: 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.
Time frame: 3 months and 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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