Continuous Erector Spinae Block for Analgesia Following Lumbar Decompression

NCT06987409 | Not Yet Recruiting

• 1 other identifier: REB 56541
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Lumbar Spinal Stenosis; Lumbar Radiculopathy; Persistent Postsurgical Pain

Keywords

Erector spinae block; Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS)

  Patient rate pain level according to a numbered scale (0-10 with worse pain being rated higher).

  24 hours

Secondary Outcomes (5)

• Quality of recovery (QoR-15)

  72 hours

• Cumulative opioid consumption (in oral morphine equivalents (OME))

  72 hours

• Time to discharge from hospital

  Up to 30 days

• Adverse events

  30 days

• Persistent postsurgical pain (PSPP)

  3 months and 6 months

Study Arms (2)

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.

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.

Procedure: Continuous erector spinae plane block

Interventions

Continuous erector spinae plane block PROCEDURE

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.

Erector spinae plane catheter with Ropivacaine; Erector spinae plane catheter with normal saline

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (aged \>18 years) patients
• Undergoing lumbar decompression surgery +/- fusion
• Under the orthopedic surgery team

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Conditions

Spinal Stenosis; Radiculopathy; Pain, Postoperative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Jonathan Bailey, MD

CONTACT

902-473-2331; jon.bailey@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Nova Scotia Health (NSH) pharmacy will prepare either Ropivacaine 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. The pharmacy will maintain the assignment list, only unmasking assignment in cases of suspected local anesthetic systemic toxicity (LAST) or allergic reactions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: May 23, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share