NCT03951038|UnknownPhase 4
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Sponsor study identifier
interventional
100
1 country
1
Study Start
August 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 14, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Surgery of the lumbar spine is characterized by diffuse and severe postoperative pain. In recent years, some case reports indicate that the thoracolumbar interfascial plane block (TLIPB) can reduce postoperative pain after spinal surgery, which targets the dorsal roots of the thoracolumbar nerves by depositing local anesthetic at the level of third lumbar vertebra between the multifidus and longissimus muscles. However, a new approach of the TLIPB technique by injecting local anesthetic between the longissimus and iliocostalis muscles, that is the Lateral TLIPB. According some relevant literature reports show that this technique simpler to perform and reduces the risk of neuraxial puncture. So, the purpose of this study is to investigate the efficacy and safety of the Lateral TLIPB combined with patient controlled intravenous analgesia (PCIA) is superior to PCIA in reducing postoperative pain in patients undergoing spinal surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 14, 2020
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 8, 2019
Actual (reported)May 15, 2019
Actual (reported)August 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 14, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Acute pain post-operatively
Pain intensity will be measured by visual analogue scale(VAS)， which included an 11-point scale with 0 labeled as "no pain" and 10 as "worst possible pain". Pain intensity was classified as mild with scores of 1～3, moderate with scores of 4～6, and severe with scores of 7～10.
6 hours post-operatively
Acute pain post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
12 hours post-operatively
Acute pain post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
24 hours post-operatively
Acute pain post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
36 hours post-operatively
Analgesic Rescue
post-operative day 1 to 2
The number of pushed and requested PCA
post-operative day 1 to 2
Incidence of adverse events associated with post-operative analgesia
post-operative day 1 to 2
Participants in this group will receive PCIA post-operatively (tramadol 800 mg and flurbiprofen axetil 100mg with saline added up to a volume of 80ml in total ) and the equal volume of 0.9% normal saline will be conducted by ultrasound and receive a single injection between the longissimus and iliocostalis muscles both sides of the spine. The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
Participants in this group will be conducted by ultrasound and receive a single injection between the longissimus and iliocostalis muscles both sides of the spine, and combined with PCIA post-operatively. The regimen of the Lateral TLIPB is 0.2% 20 ml ropivacaine respectively and the regimen of PCIA is same with PCIA group.
The formula of the PCIA included tramadol 800 mg, flurbiprofen axetil 100mg with saline added up to a volume of 80 ml in total. The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
both sides of the spine, a single injection of ropivacaine by nerve stimulating needle under ultrasound-guided between the longissimus and iliocostalis muscles . The regimen of Lateral TLIPB group is0.2% 20ml ropivacaine and the regimen of PCIA is same with PCIA group.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Ahiskalioglu A, Yayik AM, Alici HA. Ultrasound-guided lateral thoracolumbar interfascial plane (TLIP) block: Description of new modified technique. J Clin Anesth. 2017 Aug;40:62. doi: 10.1016/j.jclinane.2017.04.015. No abstract available.
Ueshima H, Hara E, Otake H. RETRACTED: Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial. J Clin Anesth. 2019 Dec;58:12-17. doi: 10.1016/j.jclinane.2019.04.026. Epub 2019 Apr 25.
Su Min, MD
First Affiliated Hospital of Chongqing Medical University
First Submitted
May 8, 2019
First Posted
May 15, 2019
Study Start
August 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 31, 2020
Acute pain post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
48 hours post-operatively
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Li C, Jia J, Qin Z, Tang Z. The use of ultrasound-guided modified thoracolumbar interfascial plane (TLIP) block for multi-level lumbar spinal surgery. J Clin Anesth. 2018 May;46:49-51. doi: 10.1016/j.jclinane.2018.01.018. Epub 2018 Mar 26. No abstract available.
Ammar MA, Taeimah M. Evaluation of thoracolumbar interfascial plane block for postoperative analgesia after herniated lumbar disc surgery: A randomized clinical trial. Saudi J Anaesth. 2018 Oct-Dec;12(4):559-564. doi: 10.4103/sja.SJA_177_18.
Ahiskalioglu A, Yayik AM, Doymus O, Selvitopi K, Ahiskalioglu EO, Calikoglu C, Alici HA, Karaca O. Efficacy of ultrasound-guided modified thoracolumbar interfascial plane block for postoperative analgesia after spinal surgery: a randomized-controlled trial. Can J Anaesth. 2018 May;65(5):603-604. doi: 10.1007/s12630-018-1051-0. Epub 2018 Jan 9. No abstract available.
Manchikanti L, Helm Ii S, Singh V, Hirsch JA. Accountable interventional pain management: a collaboration among practitioners, patients, payers, and government. Pain Physician. 2013 Nov-Dec;16(6):E635-70.
Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine (Phila Pa 1976). 2012 Jan 1;37(1):67-76. doi: 10.1097/BRS.0b013e31820cccfb.
Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
Ueshima H, Sakai R, Otake H. Clinical experiences of ultrasound-guided thoracolumbar interfascial plane block: a clinical experience. J Clin Anesth. 2016 Sep;33:499. doi: 10.1016/j.jclinane.2015.09.005. Epub 2015 Oct 23. No abstract available.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 14, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 15, 2019
Record last verified: 2019-05
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