Study Results
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Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2016-02-29
2017-07-30
Brief Summary
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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.
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Detailed Description
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Additionally, the investigators will compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) values for monitoring the efficacy of analgesia postoperatively. After emergence from GA patients will be questioned in terms of their pain intensity in a scale 0-10. In the case of pain perception above 3, a bolus of 2mg of morphine will be administered intravenously every 10 minutes until pain perception will be lower than 4. SPI values will be recorded every 1 minute and analysed for aute pain (NRS 7-10), average (4-6) and mild pain perception intervals to assess if there exists a correlation between NRS and SPI.
In addition, some patients develop Failed Back Surgery Syndrome (FBSS) following lumbar surgeries so the investigators will aim to analyze if SPI-directed analgesia intra- and post-operatively reduces rate of FBSS. After 5 months after operation patient will be surveyed using melzack protocol to assess the rate of FBSS as well as symptoms of chronic pain.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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bupivacaine, LA, solution
an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data
Metamizol
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram with following intravenous infusion of 5 grams per day.
Tramadol
in group A patients will receive pre-emptive analgesia using intravenous infusion of tramadol in a single dose of 2 mg per hg of body weight with following intravenous infusion of 400 mg per day.
Ropivacaine
patients in group RF will receive local wound infiltration with a solution of 0,2% ropivacaine in a volume of 10 ml per segment of vertrebral columne.
control group
patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.
ropivacaine, LA, solution
an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data
Metamizol
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram with following intravenous infusion of 5 grams per day.
Tramadol
in group A patients will receive pre-emptive analgesia using intravenous infusion of tramadol in a single dose of 2 mg per hg of body weight with following intravenous infusion of 400 mg per day.
Bupivacaine
patients in group BF will receive local wound infiltration with a solution of 0,2% bupivacaine in a volume of 10 ml per segment of vertrebral columne.
control group
patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.
metamizol, analgesic, solution
an analgesic drug administered intravenously for pre-emptive analgesia in a initial dose of 1-1,25g with potential duration time of up to 6 hours according to manufacturers data
Bupivacaine
patients in group BF will receive local wound infiltration with a solution of 0,2% bupivacaine in a volume of 10 ml per segment of vertrebral columne.
Ropivacaine
patients in group RF will receive local wound infiltration with a solution of 0,2% ropivacaine in a volume of 10 ml per segment of vertrebral columne.
control group
patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.
tramadol, analgesic, solution
a half-opioid drug administered intravenously for pre-emptive analgesia in a initial dose of 2 mg per kg of body weight with potential duration time of up to 6 hours according to manufacturers data
Metamizol
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram with following intravenous infusion of 5 grams per day.
Tramadol
in group A patients will receive pre-emptive analgesia using intravenous infusion of tramadol in a single dose of 2 mg per hg of body weight with following intravenous infusion of 400 mg per day.
Bupivacaine
patients in group BF will receive local wound infiltration with a solution of 0,2% bupivacaine in a volume of 10 ml per segment of vertrebral columne.
Ropivacaine
patients in group RF will receive local wound infiltration with a solution of 0,2% ropivacaine in a volume of 10 ml per segment of vertrebral columne.
control group
no pre-emptive analgesia will be used.
Metamizol
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram with following intravenous infusion of 5 grams per day.
Tramadol
in group A patients will receive pre-emptive analgesia using intravenous infusion of tramadol in a single dose of 2 mg per hg of body weight with following intravenous infusion of 400 mg per day.
Bupivacaine
patients in group BF will receive local wound infiltration with a solution of 0,2% bupivacaine in a volume of 10 ml per segment of vertrebral columne.
Ropivacaine
patients in group RF will receive local wound infiltration with a solution of 0,2% ropivacaine in a volume of 10 ml per segment of vertrebral columne.
control group
patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.
Interventions
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Metamizol
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram with following intravenous infusion of 5 grams per day.
Tramadol
in group A patients will receive pre-emptive analgesia using intravenous infusion of tramadol in a single dose of 2 mg per hg of body weight with following intravenous infusion of 400 mg per day.
Bupivacaine
patients in group BF will receive local wound infiltration with a solution of 0,2% bupivacaine in a volume of 10 ml per segment of vertrebral columne.
Ropivacaine
patients in group RF will receive local wound infiltration with a solution of 0,2% ropivacaine in a volume of 10 ml per segment of vertrebral columne.
control group
patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* written consent to undergo general anaesthesia with local wound infiltration and surgery of discectomy
Exclusion Criteria
* necessity of administration of vasoactive drugs influencing SPI monitoring
* pregnancy
18 Years
80 Years
ALL
No
Sponsors
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Silesian University of Medicine
OTHER
Medical University of Silesia
OTHER
Responsible Party
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Michał Stasiowski
Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy
Principal Investigators
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Michał J Stasiowski, M.D
Role: PRINCIPAL_INVESTIGATOR
Medical University of Silesia
Locations
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Medical University of Silesia
Sosnowiec, Silesian Voivodeship, Poland
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SilesianMUKOAiIT1
Identifier Type: -
Identifier Source: org_study_id
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