Efficacy and Safety of Ultrasound-guided Lateral Thoracolumbar Interfascial Plane Block (TLIPB) for Postoperative Pain in Patients Undergoing Herniated Lumbar Disc Surgery

NCT03951038 | Unknown Phase 4

• 1 other identifier: CQMUAZD2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Lumbar Disc Surgery

Keywords

Lumbar disc herniation; Postoperative analgesia; Patient controlled intravenous analgesia; Nerve block; thoracolumbar

Outcome Measures

Primary Outcomes (5)

• 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

• Acute pain post-operatively

  Pain intensity will be measured by visual analogue scale(VAS)

  48 hours post-operatively

Secondary Outcomes (3)

• 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

Study Arms (2)

PCIA group

ACTIVE COMPARATOR

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.

Procedure: PCIA group

Lateral TLIPB group

EXPERIMENTAL

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.

Procedure: Lateral TLIPB group

Interventions

PCIA group PROCEDURE

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.

PCIA group

Lateral TLIPB group PROCEDURE

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.

Also known as: Nerve block

Lateral TLIPB group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men or woman and 18～65 years old
• clinical diagnosis of umbar disc herniation and will receive selective Lumbar disc surgery

You may not qualify if:

• age below 18 years or over 65 years;
• American Society of Anesthesiologists grade III or greater;
• Diabetes;
• allergic to local anesthetics;
• cognitive impairment or communication problems;
• received opioids、NSAID or tranquilizers (treatment for over 1 wk before the surgery);
• history of alcohol or drug abuse;
• severe hepatic or renal impairment ;
• post-operative severe complications(e.g. pyogenic infection)

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (9)

• 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.

  PMID: 28625449 BACKGROUND

• 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.

  PMID: 31029989 BACKGROUND

• 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.

  PMID: 29414616 BACKGROUND

• 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.

  PMID: 30429737 BACKGROUND

• 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.

  PMID: 29318534 BACKGROUND

• 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.

  PMID: 24284849 BACKGROUND

• 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.

  PMID: 21311399 BACKGROUND

• 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.

  PMID: 26149600 BACKGROUND

• 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.

  PMID: 26507177 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Intervertebral Disc Displacement

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Su Min, MD

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Zhang, Master

CONTACT

+86-23-89011061; 848138113@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 15, 2019
• Study Start: August 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: February 14, 2020
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

CN (1)