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This randomized controlled trial evaluates the effectiveness of ultrasound-guided retrolaminar nerve block in addition to standard multimodal analgesia for postoperative pain management in patients undergoing lumbar spine surgery. Fifty patients will be randomly assigned to receive either the retrolaminar block combined with standard pain management or standard pain management alone. The primary outcome is total opioid consumption in the first 24 hours after surgery. Secondary outcomes include pain intensity at multiple time points, time to first rescue analgesia, duration of sensory block, incidence of postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and chronic pain development at 3 and 6 months follow-up.
BACKGROUND: Lumbar spine surgery is associated with significant postoperative pain, which can delay recovery and increase complications. Regional anesthesia techniques, specifically retrolaminar blocks, may provide superior analgesia compared to systemic opioids alone.
STUDY DESIGN: This is a prospective, randomized, controlled trial conducted at ClÃnica Universidad de Los Andes, Chile. Patients will be allocated using variable block randomization (block sizes 4 and 6) in a 1:1 ratio.
INTERVENTIONS: All patients will receive standardized general anesthesia (Propofol, Remifentanil, Rocuronium) and multimodal analgesia including paracetamol, metamizol, ketorolac, morphine, and pregabalin. The intervention group will additionally receive bilateral ultrasound-guided retrolaminar blocks with ropivacaine 0.5% (20 ml per side) at the end of surgery.
OUTCOMES: Primary outcome is cumulative morphine consumption via patient-controlled analgesia (PCA) during the first 24 postoperative hours. Secondary outcomes include pain scores (VAS 0-10) at 0, 6, 12, 24, 48, and 72 hours; time to first rescue analgesia; duration of sensory block; incidence of nausea/vomiting; hospital length of stay; time to ambulation; sleep quality; patient satisfaction; adverse events; and development of chronic pain at 3 and 6 months.
SAMPLE SIZE: 50 patients (25 per group) provides 80% power to detect a clinically significant difference in opioid consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrolaminar Block & Standard Analgesia | Experimental | Patients receive bilateral ultrasound-guided retrolaminar blocks with Bupivacaine 0.25% and Epinephrine 50mcg (15 ml total volume per side) before surgery, along with standard multimodal analgesia. |
|
| Standard Analgesia Only | Active Comparator | Patients receive standard multimodal analgesia without regional anesthesia block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-Guided Retrolaminar Block | Procedure | Patients will receive bilateral ultrasound-guided retrolaminar blocks with Bupivacaine 0.25% and Epinephrine 50mcg (15 ml total volume per side) before surgery. The block will be performed by an experienced anesthesiologist using real-time ultrasound guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| Total postoperative opioid consumption | Cumulative morphine consumption (in mg morphine equivalents) delivered via patient-controlled analgesia (PCA) pump during the first 24 postoperative hours | First 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain intensity measured using Visual Analog Scale (VAS, 0-10 where 0=no pain and 10=worst imaginable pain) Time Frame: 0, 6, 12, 24, 48, and 72 hours postoperatively | Time in minutes from end of surgery until first request for rescue analgesia Time Frame: From end of surgery up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient satisfaction with pain management measured using 5-point Likert scale (1=very dissatisfied to 5=very satisfied) | 72 hours postoperatively |
| Chronic Pain Development | Incidence of chronic pain defined as VAS > 3 at surgical site |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Coloma, MD | Contact | (56) 22 618 3100 | rcoloma@clinicauandes.cl | |
| Nicolás Valls, MD, PhD | Contact | +56 9 33741332 | nvalls@clinicauandes.cl |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas J Valls, M.D, Ph.D | Anesthesiologyst, Clinica Universidad de los Andes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Universidad de los Andes, Chile | Recruiting | Santiago | Santiago Metropolitan | 171571 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23662765 | Background | Zeballos JL, Voscopoulos C, Kapottos M, Janfaza D, Vlassakov K. Ultrasound-guided retrolaminar paravertebral block. Anaesthesia. 2013 Jun;68(6):649-51. doi: 10.1111/anae.12296. No abstract available. | |
| 31047129 | Background | Ardon AE, Prasad A, McClain RL, Melton MS, Nielsen KC, Greengrass R. Regional Anesthesia for Ambulatory Anesthesiologists. Anesthesiol Clin. 2019 Jun;37(2):265-287. doi: 10.1016/j.anclin.2019.01.005. Epub 2019 Mar 15. |
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Individual participant data that underlie the results reported in the published article, after deidentification, will be available upon reasonable request.
Data will be available beginning 6 months and ending 5 years following article publication.
Data will be shared with researchers who provide a methodologically sound proposal for use in achieving the aims of the approved proposal. Proposals should be directed to rcoloma@clinicauandes.cl. To gain access, data requestors will need to sign a data access agreement. Data will be shared after approval by the principal investigator and the institutional review board.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2025 | Nov 6, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 24, 2025 | Jan 5, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Randomized, Parallel Assignment, Blinded outcome assessment
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Outcomes assessors (including pain evaluators and data collectors) will be blinded to group allocation.
The anesthesiologist performing the intervention and the patient cannot be blinded due to the nature of the procedure (performance of nerve block).
Postoperative care providers will also be blinded to treatment allocation.
|
| Standard Analgesia | Other | Patients receive standard multimodal analgesia without regional anesthesia block. |
|
| Duration of Sensory Block |
Duration in hours from block performance until complete sensory recovery assessed by thermal and tactile testing |
| From block performance up to 72 hours |
| Time to First Rescue Analgesia | Time in minutes from end of surgery until first request for rescue analgesia | From end of surgery up to 24 hours |
| Incidence of PONV | Incidence of postoperative nausea and vomiting (PONV) requiring antiemetic rescue medication | First 24 hours postoperatively |
| Length of hospital stay | Total number of days from hospital admission to discharge | From admission to discharge, assessed up to 30 days |
| 3 months and 6 months postoperatively |
| 21804697 | Background | Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available. |
| 23392233 | Background | Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |