Postoperative PainREALMNCT07334288
Retrolaminar Analgesia for LuMbar Surgery
A study testing Ultrasound-Guided Retrolaminar Block and Standard Analgesia in people with Postoperative Pain and Lumbar Surgery, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Lumbar Surgery, Back Pain Lower Back Chronic
- What is being tested?
- Ultrasound-Guided Retrolaminar Block and Standard Analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2026to 1 Jun 2027
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-80 years
- 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
Who cannot join
- Refusal to participate in the study
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Clínica Universidad de los Andes, Chile
Santiago, Santiago Metropolitan, 171571
Roberto Coloma, MD, +56 22 618 3100, rcoloma@clinicauandes.cl
About this study
Official title: Efficacy of Ultrasound-Guided Retrolaminar Block Combined With Standard Multimodal Analgesia for Postoperative Pain Management in Lumbar Spine Surgery: A Randomized Controlled Trial
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.
Read the detailed description
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 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
- Postoperative Pain, Lumbar Surgery, Back Pain Lower Back Chronic, Opioid Analgesia, Regional Anaesthesia
- Being tested
- Ultrasound-Guided Retrolaminar Block, Standard Analgesia
- Keywords
- retrolaminar block, regional anesthesia, lumbar spine surgery, Multimodal analgesia, opioid consumption, Ultrasound-guided nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Retrolaminar BlockProcedure or surgery
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 AnalgesiaOther
Patients receive standard multimodal analgesia without regional anesthesia block.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ultrasound-Guided Retrolaminar Block |
| Standard Analgesia Only | Active comparator | Patients receive standard multimodal analgesia without regional anesthesia block. Receives: Other: Standard Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative opioid consumption
Cumulative morphine consumption (in mg morphine equivalents) delivered via patient-controlled analgesia (PCA) pump during the first 24 postoperative hours
Measured: First 24 hours after surgery
Secondary outcomes (5)
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
Measured: Time in minutes from end of surgery until first request for rescue analgesia Time Frame: From end of surgery up to 72 hours
Duration of Sensory Block
Duration in hours from block performance until complete sensory recovery assessed by thermal and tactile testing
Measured: 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
Measured: From end of surgery up to 24 hours
Incidence of PONV
Incidence of postoperative nausea and vomiting (PONV) requiring antiemetic rescue medication
Measured: First 24 hours postoperatively
Length of hospital stay
Total number of days from hospital admission to discharge
Measured: From admission to discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Randomized, Parallel Assignment, Blinded outcome assessment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolás Valls, Universidad de los Andes, Chile
- Investigators
- Nicolas J Valls, M.D, Ph.D, Study director, Anesthesiologyst, Clinica Universidad de los Andes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334288
- Sponsor's protocol ID
- CUA2025-42
- Acronym
- REALM
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification, will be available upon reasonable request.
Publications
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.
PubMed 23662765Ardon 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.
PubMed 31047129Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
PubMed 21804697Gerbershagen 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.
PubMed 23392233
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-Guided Retrolaminar Block Combined With Standard Multimodal Analgesia for Postoperative Pain Management in Lumbar Spine Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07334288
- Acronym / sponsor ID
- REALM / CUA2025-42
- Conditions
- Postoperative Pain, Lumbar Surgery, Back Pain Lower Back Chronic, Opioid Analgesia, Regional Anaesthesia
- Keywords
- retrolaminar block, regional anesthesia, lumbar spine surgery, Multimodal analgesia, opioid consumption, Ultrasound-guided nerve block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Jan 2026 (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.
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.
Detailed description
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Parallel Assignment, Blinded outcome assessment
| Arm | Type | Receives |
|---|---|---|
| Retrolaminar Block & Standard Analgesia | Experimental | Procedure: Ultrasound-Guided Retrolaminar BlockPatients 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 | Other: Standard AnalgesiaPatients receive standard multimodal analgesia without regional anesthesia block. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18-80 years
- 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
Key exclusion criteria (10 listed)
- Refusal to participate in the study
- 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
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 |
|---|---|---|
| Ultrasound-Guided Retrolaminar BlockPatients 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. | Procedure or surgery | Retrolaminar Block & Standard Analgesia |
| Standard AnalgesiaPatients receive standard multimodal analgesia without regional anesthesia block. | Other | Standard Analgesia Only |
Primary outcome
Total postoperative opioid consumption
Time frame: First 24 hours after surgery
Cumulative morphine consumption (in mg morphine equivalents) delivered via patient-controlled analgesia (PCA) pump during the first 24 postoperative hours
5 secondary outcomes
Pain Intensity
Time frame: Time in minutes from end of surgery until first request for rescue analgesia Time Frame: From end of surgery up to 72 hours
Duration of Sensory Block
Time frame: From block performance up to 72 hours
Time to First Rescue Analgesia
Time frame: From end of surgery up to 24 hours
Incidence of PONV
Time frame: First 24 hours postoperatively
Length of hospital stay
Time frame: From admission to discharge, assessed up to 30 days
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 13 Apr 2026.
- Background: PubMed 23662765Zeballos 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.
- Background: PubMed 31047129Ardon 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.
- Background: PubMed 21804697Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
- Background: PubMed 23392233Gerbershagen 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after deidentification, will be available upon reasonable request.
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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.
Nicolas J Valls, M.D, Ph.D study director
Anesthesiologyst, Clinica Universidad de los Andes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Retrolaminar Block and Standard Analgesia in people with Postoperative Pain and Lumbar Surgery, run by Universidad de los Andes, Chile at 1 site in Chile.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Roberto Coloma, MD ((56) 22 618 3100, rcoloma@clinicauandes.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative opioid consumption (time frame: First 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07334288, which also lists 4 linked publications.
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 13 Apr 2026.