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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrolaminar block | Experimental | Participants 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. |
|
| Sham block | Sham Comparator | Participants 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption during the first 24 hours postoperative | To assess rescue opioid consumption, expressed as morphine equivalents, during the first 24 hours postoperative. | Daily consumption during the first 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Carlos De la Cuadra-Fontaine, MD | Contact | 5695337297 | juancarl@ucchristus.cl | |
| Victor Contreras, MSN | Contact | 56223543414 | 3414 | vecontre@uc.cl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Pontificia Universidad Católica de Chile | Recruiting | Santiago | Santiago Metropolitan | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 25822730 | Background | 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. |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D013122 | Spinal Diseases |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized, blinded, two-group clinical trial
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Due to the nature of the intervention, both patients and healthcare personnel involved in the intraoperative and postoperative care of the patients will be blinded to the intervention.
| 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. |
|
| Daily NRS during the first 3 postoperative days |
| 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. | Preoperative score and daily score during the first 3 postoperative days |
| 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. | Intraoperative and during the first 3 days |
| 39231035 | Background | 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. |
| 32711832 | Background | 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. |
| 35617645 | Background | 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. |
| 23797663 | Background | 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. |
| 31032339 | Background | 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. |
| 37450909 | Background | 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. |
| 38886235 | Background | 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. |
| 32766467 | Background | 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. |
| 36414472 | Background | 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. |
| 26787793 | Background | 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. |
| 38834814 | Background | 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. |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |