drugset / Trial / NCT02971540
SPI-directed Analgesia for Lumbar Discectomy
RandomizedParallel-groupSingle-blindDiagnostic
Summary
The aim of this randomized trial is to assess the efficacy of analgesia for lumbar discectomy and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively. Patients received either preemptive local tissue infiltration at surgical site using either 0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous infusion using metamizole and tramadol.
Timeline
- Start
- 2016-02
- Primary completion
- 2017-07-30
- Completion
- 2017-07-30
Publications
- Background Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.
- Background Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.
- Background Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.
- Background Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.
- Background Cherian MN, Mathews MP, Chandy MJ. Local wound infiltration with bupivacaine in lumbar laminectomy. Surg Neurol. 1997 Feb;47(2):120-2; discussion 122-3. doi: 10.1016/s0090-3019(96)00255-8.
- Background Hernandez-Palazon J, Tortosa Serrano JA, Burguillos Lopez S, Molero Molero E. [Infiltration of the surgical wound with local anesthetic for postoperative analgesia in patients operated on for lumbar disc herniation. Comparative study of ropivacaine and bupivacaine]. Rev Esp Anestesiol Reanim. 2001 Jan;48(1):17-20. Spanish.
- Background Gurbet A, Bekar A, Bilgin H, Korfali G, Yilmazlar S, Tercan M. Pre-emptive infiltration of levobupivacaine is superior to at-closure administration in lumbar laminectomy patients. Eur Spine J. 2008 Sep;17(9):1237-41. doi: 10.1007/s00586-008-0676-z. Epub 2008 Apr 19.
- Background Ozyilmaz K, Ayoglu H, Okyay RD, Yurtlu S, Koksal B, Hanci V, Erdogan G, Turan IO. Postoperative analgesic effects of wound infiltration with tramadol and levobupivacaine in lumbar disk surgeries. J Neurosurg Anesthesiol. 2012 Oct;24(4):331-5. doi: 10.1097/ANA.0b013e3182611a1d.
- Background Chae SU, Kim TK, Shim DM, Kim YJ, Choi DH. Is complex regional pain syndrome a cause of post-operative syndrome in the lumbar spine? - a case report -. Asian Spine J. 2009 Dec;3(2):101-5. doi: 10.4184/asj.2009.3.2.101. Epub 2009 Dec 31.
- Background Yalbuzdag SA, Erol AM, Sengul I, Celik C, Solum S, Adilay HU, Gungor B. Temperament and Character Profile in Failed Back Surgery Syndrome: A Cross-Sectional Clinical Study. Turk Neurosurg. 2016;26(6):912-917. doi: 10.5137/1019-5149.JTN.13679-14.0.
- Results Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 0.2 % | Other |
| Subject | Bupivacaine | Other / unclassified | 10 ml | Other |
| Subject | Ropivacaine | Other / unclassified | 0.2 % | Other |
| Subject | Ropivacaine | Other / unclassified | 10 ml | Other |
| Subject | Tramadol | Other / unclassified | 400 mg | Intravenous |
| Subject | dipyrone | Unknown | 5 g | Intravenous |