Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2026-01-01
2027-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Ultrasound Guidance on Central Neuraxial Block Success in Patients With Non-Palpable Vertebral Anatomy
NCT07269184
Ultrasound Guidance in Nerve Block Anaesthesia
NCT00213954
Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block
NCT02737527
Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia
NCT03491943
Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery
NCT01734954
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
STUDY DESIGN: This is a prospective, randomized, controlled trial conducted at Clínica 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Retrolaminar Block & Standard Analgesia
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.
Ultrasound-Guided Retrolaminar Block
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.
Standard Analgesia Only
Patients receive standard multimodal analgesia without regional anesthesia block.
Standard Analgesia
Patients receive standard multimodal analgesia without regional anesthesia block.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ultrasound-Guided Retrolaminar Block
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.
Standard Analgesia
Patients receive standard multimodal analgesia without regional anesthesia block.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Scheduled for elective lumbar spine surgery (with instrumentation)
* American Society of Anesthesiologists (ASA) physical status I-III
* Willing and able to provide written informed consent
* Able to use patient-controlled analgesia (PCA) device
Exclusion Criteria
* Known allergy to local anesthetics (bupivacaine - levobupivacaine - lidocaine) or any study medication
* Contraindication to regional anesthesia (infection at injection site, coagulopathy)
* Chronic opioid use (daily use for \>3 months prior to surgery)
* Severe psychiatric disorder that precludes informed consent
* Emergency surgery
* Diabetes mellitus with preoperative glucose \>180 mg/dl
* Pregnancy or breastfeeding
* Body mass index (BMI) \>40 kg/m²
* Reoperation or revision of the same level of previous spinal surgery
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de los Andes, Chile
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nicolás Valls
Anesthesiologyst, Anesthesiology Department, Clínica Universidad de Los Andes
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicolas J Valls, M.D, Ph.D
Role: STUDY_DIRECTOR
Anesthesiologyst, Clinica Universidad de los Andes
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clínica Universidad de los Andes, Chile
Santiago, Santiago Metropolitan, Chile
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CUA2025-42
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.