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NCT Number: NCT07291388

Effectiveness of Retrolaminar Block in 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.

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Key information

Conditions

Acute Pain Anesthesia Ankylosis Bone Diseases Joint Diseases Lumbar Spine Disease Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

Location status: Recruiting

Location contact

Victor Contreras, MSN

CONTACT

[email protected]

56981895232

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

retrolaminar block

Procedure

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

Sham Block

Procedure

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.

Primary outcomes

  1. Opioid consumption during the first 24 hours postoperative

    Time frame: Daily consumption during the first 24 hours

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

Secondary outcomes

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

    Time frame: Daily 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.

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

    Time frame: Preoperative score and daily score 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.

  3. bleeding and transfusions

    Time frame: Intraoperative and during the first 3 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Carlos De la Cuadra-Fontaine, MD

CONTACT

[email protected]

5695337297

Victor Contreras, MSN

CONTACT

[email protected]

56223543414 ext. 3414

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Acronym: RBLUF

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 18, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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