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Acute PainRBLUFNCT07291388

Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia

A study testing retrolaminar block in people with Acute Pain and Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This randomized, blinded, controlled clinical trial aims to evaluate the effectiveness of ultrasound-guided retrolaminar block in reducing postoperative opioid consumption in patients undergoing lumbar spine fusion surgery under multimodal analgesia. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Acute Pain, Anesthesia, Lumbar Spine Disease
What is being tested?
retrolaminar block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteChile
Study dates
30 Jun 2026to Mar 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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-75 years, scheduled for lumbar spine fusion surgery by a trauma team
  • American Society of Anesthesiologists (ASA) Classification I-III
  • Willing and able to provide written informed consent to participate in the study.

Who cannot join

  • History of chronic use of strong or weak opioids for more than 3 months.
  • Diagnosis of chronic pain and treatment by a pain management team.
  • ASA score greater than or equal to 4.
  • Patients with prior lumbar spine surgery. Spinal instrumentation at the surgical site.
  • Estimated creatinine clearance less than 60 ml/min.
  • Coagulation disorder or abnormal coagulation tests.
Show all 13Show fewer
  • Infection at the surgical site.
  • Weight less than 50 kg.
  • Altered mental status that prevents reliable evaluation.
  • Allergy to local anesthetics or analgesic drugs used in the study.
  • Patients with contraindications to peripheral nerve blocks.
  • Lumbar spine fixation due to oncologic disease or acute trauma.
  • Use of intraoperative neuromonitoring and TIVA.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juan Carlos De la Cuadra-Fontaine, MD contact

5695337297

juancarl@ucchristus.cl

Victor Contreras, MSN contact

56223543414 ext. 3414

vecontre@uc.cl

Chile1 site, 1 recruiting
  • Hospital Clínico Pontificia Universidad Católica de Chile

    Santiago, Santiago Metropolitan

    Victor Contreras, MSN, 56981895232, vecontre@uc.cl

    Recruiting

Other trials in Chile

About this study

Official title: Effectiveness of Retrolaminar Block in Reducing Postoperative Opioid Consumption in Patients Undergoing Lumbar Spine Fusion With Multimodal Analgesia

This randomized, blinded, controlled clinical trial aims to evaluate the effectiveness of ultrasound-guided retrolaminar block in reducing postoperative opioid consumption in patients undergoing lumbar spine fusion surgery under multimodal analgesia.

The participants will:

  • Be randomly assigned in a 1:1 ratio to receive either a retrolaminar block with 0.25% bupivacaine plus epinephrine or a sham block (normal saline) prior to surgical incision.
  • Receive standardized multimodal analgesia.
  • Have follow-up by the Acute Pain Unit during the first 3 days, to assess opioid consumption (morphine) in 24 hours, pain intensity measured by Numeric Rating Scale, quality of recovery assessed by the QoR-15 questionnaire, intraoperative blood loss, and postoperative complications.
Read the detailed description

After obtaining approval from the institutional CEC-CCSS and prospective registration of the study at clinicaltrials.org, the investigators will recruit patients who meet the inclusion criteria and provide written consent.

Being tested
retrolaminar block, Sham block
Keywords
acute pain, retrolaminar block, regional anesthesia, lumbar arthrodesis
Medical subject headings
Acute Pain, Spinal Diseases, Ankylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • retrolaminar blockProcedure or surgery

    Retrolaminar block with bupivacaine and epinephrine on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.

  • Sham blockProcedure or surgery

    Sham block in the retrolaminar area with saline solution on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.

Study groups in NCT07291388
Study groupRoleWhat they receive
Retrolaminar blockExperimentalParticipants received retrolaminar block with 0.25% Bupivacaine (20 ml) plus epinephrine (5 mcg/ml), on both sides of the vertebral lamina, and a subcutaneous injection in the area of the surgical incision with 20 ml of the same concentration and dose used previously.
Receives: Procedure: retrolaminar block
Sham blockSham comparatorParticipants received a retrolaminar sham block with 0.9% saline solution (20 ml), on both sides of the vertebra lamina, and a subcutaneous injection in the area of the surgical incision with 20 ml of the same concentration and dose used previously.
Receives: Procedure: Sham block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid consumption during the first 24 hours postoperative

    To assess rescue opioid consumption, expressed as morphine equivalents, during the first 24 hours postoperative.

    Measured: Daily consumption during the first 24 hours

Secondary outcomes (3)
  1. Daily Numeric Rating Score (NRS) during the first 3 postoperative days

    The NRS (Numeric Rating Scale) is commonly used to assess pain intensity. Its minimum score is 0, indicating no pain, and its maximum score is 10, indicating the worst pain imaginable. This scale is simple and allows patients to rate their pain using a number from 0 to 10. The objective is to assess the intensity of acute postoperative pain, expressed as NRS, during the first 3 postoperative days.

    Measured: Daily NRS during the first 3 postoperative days

  2. Daily score on the "Quality of Recovery-15" (QoR-15) scale during the first 3 postoperative days.

    The QoR-15 is a validated instrument in the literature that assesses the quality of recovery in patients after surgery. It is a multidimensional measurement tool that allows healthcare professionals to gain an overview of the patient's well-being during the postoperative period. The questionnaire consists of 15 items, covering 5 dimensions: Physical Comfort, Physical Independence, Emotional Support, Psychological Well-being, and Satisfaction with Recovery. The minimum score on the scale is 0 points, and the maximum score is 150 points. This range is obtained by summing the scores of the different categories evaluated in the QoR-15 scale, where a higher score indicates a better quality of postoperative recovery.

    Measured: Preoperative score and daily score during the first 3 postoperative days

  3. bleeding and transfusions

    Subjective assessment of total intraoperative bleeding (mild, moderate, severe), blood in collectors, number of compresses with blood, hematocrit variations at 24 hours after the procedure and need for transfusion in the perioperative period.

    Measured: Intraoperative and during the first 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start30 Jun 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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, blinded, two-group clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07291388
Sponsor's protocol ID
241022008
Acronym
RBLUF
Status last verified
Aug 2025
First submitted
5 Dec 2025
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23392233
  • Machado GC, Ferreira PH, Harris IA, Pinheiro MB, Koes BW, van Tulder M, Rzewuska M, Maher CG, Ferreira ML. Effectiveness of surgery for lumbar spinal stenosis: a systematic review and meta-analysis. PLoS One. 2015 Mar 30;10(3):e0122800. doi: 10.1371/journal.pone.0122800. eCollection 2015.

    PubMed 25822730
  • Pepper CG, Mikhaeil JS, Khan JS. Perioperative Regional Anesthesia on Persistent Opioid Use and Chronic Pain after Noncardiac Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Anesth Analg. 2024 Oct 1;139(4):711-722. doi: 10.1213/ANE.0000000000006947. Epub 2024 Sep 4.

    PubMed 39231035
  • Kaye AD, Kandregula S, Kosty J, Sin A, Guthikonda B, Ghali GE, Craig MK, Pham AD, Reed DS, Gennuso SA, Reynolds RM, Ehrhardt KP, Cornett EM, Urman RD. Chronic pain and substance abuse disorders: Preoperative assessment and optimization strategies. Best Pract Res Clin Anaesthesiol. 2020 Jun;34(2):255-267. doi: 10.1016/j.bpa.2020.04.014. Epub 2020 May 7.

    PubMed 32711832
  • Garg B, Ahuja K, Sharan AD. Regional Anesthesia for Spine Surgery. J Am Acad Orthop Surg. 2022 Sep 1;30(17):809-819. doi: 10.5435/JAAOS-D-22-00101. Epub 2022 May 25.

    PubMed 35617645
  • Voscopoulos C, Palaniappan D, Zeballos J, Ko H, Janfaza D, Vlassakov K. The ultrasound-guided retrolaminar block. Can J Anaesth. 2013 Sep;60(9):888-95. doi: 10.1007/s12630-013-9983-x.

    PubMed 23797663
  • Onishi E, Toda N, Kameyama Y, Yamauchi M. Comparison of Clinical Efficacy and Anatomical Investigation between Retrolaminar Block and Erector Spinae Plane Block. Biomed Res Int. 2019 Mar 28;2019:2578396. doi: 10.1155/2019/2578396. eCollection 2019.

    PubMed 31032339
  • Karmakar MK, Sivakumar RK, Sheah K, Pangthipampai P, Lonnqvist PA. Quest for the Elusive Mechanism of Action for the Thoracic Paraspinal Nerve Block Techniques. Are We Ignoring the Anatomy of the "Retro Superior Costotransverse Ligament Space?". Anesth Analg. 2023 Aug 1;137(2):458-465. doi: 10.1213/ANE.0000000000006462. Epub 2023 Jul 14. No abstract available.

    PubMed 37450909
  • Peker K, Aydin G, Gencay I, Saracoglu AG, Sahin AT, Ogden M, Peker SA. The effect of preemptive retrolaminar block on lumbar spinal decompression surgery. Eur Spine J. 2024 Nov;33(11):4253-4261. doi: 10.1007/s00586-024-08219-4. Epub 2024 Jun 17.

    PubMed 38886235
  • Schnabel A, Yahiaoui-Doktor M, Meissner W, Zahn PK, Pogatzki-Zahn EM. Predicting poor postoperative acute pain outcome in adults: an international, multicentre database analysis of risk factors in 50,005 patients. Pain Rep. 2020 Jul 27;5(4):e831. doi: 10.1097/PR9.0000000000000831. eCollection 2020 Jul-Aug.

    PubMed 32766467
  • Morales-Ariza V, Loaiza-Aldean Y, de Miguel M, Pena-Navarro M, Martinez-Silva O, Gonzalez-Tallada A, Manrique-Munoz S, de Nadal M. Validation and cross-cultural adaptation of the postoperative quality of recovery 15 (QoR-15) questionnaire for Spanish-speaking patients: A prospective cohort study. Am J Surg. 2023 Apr;225(4):740-747. doi: 10.1016/j.amjsurg.2022.11.009. Epub 2022 Nov 17.

    PubMed 36414472
  • Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.

    PubMed 26787793
  • Kaciroglu A, Ekinci M, Gurbuz H, Ulusoy E, Ekici MA, Dogan O, Golboyu BE, Alver S, Ciftci B. Surgical vs ultrasound-guided lumbar erector spinae plane block for pain management following lumbar spinal fusion surgery. Eur Spine J. 2024 Jul;33(7):2630-2636. doi: 10.1007/s00586-024-08347-x. Epub 2024 Jun 4.

    PubMed 38834814

Questions about this trial

What is this clinical trial studying?

A study testing retrolaminar block in people with Acute Pain and Anesthesia, run by Pontificia Universidad Catolica de 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 3 inclusion and 13 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 6 Jul 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. Some participants in this study may receive a placebo. 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 Juan Carlos De la Cuadra-Fontaine, MD (5695337297, juancarl@ucchristus.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid consumption during the first 24 hours postoperative (time frame: Daily consumption during the first 24 hours). 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 NCT07291388, which also lists 13 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 6 Jul 2026.

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