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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03951038
• Other study ID #: CQMUAZD2019
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2019
• Est. completion date: February 14, 2020

Study information

• Verified date: May 2019
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Dong Zhang, Master
• Phone: +86-23-89011061
• Email: 848138113[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Although the number of spinal surgeries has been increasing for many years, the methods for perioperative pain relief have remained limited. According to some report show that surgery of the lumbar spine is characterized by diffuse and severe postoperative pain. Pre/postoperative oral opioids, gabapentinoids, nonsteroidal antiinflammatory drugs are frequently included in multimodal analgesia for spinal surgery, but the effect was not satisfactory. The ultrasound-guided thoracolumbar interfascial plane block (TLIPB) is a peripheral nerve block, which injecting local anesthetic between the muitifidus and longissimus muscles at the level of 3rd lumbar vertebra and can block the dorsal rami of thoracolumbar nerves. TLIPB have the potential to provide long-lasting postoperative analgesia and reduce opioid consumption while minimizing the motor block associated with neuraxial and plexus blocks. However, a new approach of the TLIPB technique by injecting local anesthetic between the longissimus and iliocostalis muscles, that is the Lateral TLIPB. Comparing with the TLIPB, Lateral TLIPB have some advantages, first; ultrasonographic identification of the multifidus and longissimus muscles may be difficult, and it is easier to find the plane between the longissimus and iliocostal muscles, so, the success rate of puncture is higher; secondly; lateral to medial needle advancement can cause inadvertent neuroaxial puncture. A medial to lateral approach may be safer to perform to avoid dural 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.

This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, double-blind, controlled clinical trial guided by the standard of good clinical practice (GCP), and eligible participants are divided into two groups: group Lateral TLIPB and group PCIA, and primary assess the outcomes of the intensity of acute pain after Lumbar disc surgery.

Participants in group Lateral TLIPB will receive a single injection local anesthetic at the level of third lumbar vertebra between the longissimus and iliocostalis muscles on either side of the spine, and combined with PCIA post-operatively.

Participants in group PCIA will receive the equal volume of 0.9% normal saline between the longissimus and iliocostalis muscles on either side of the spine and PCIA post-operatively.

The primary outcome of this study is the intensity of acute pain after Lumbar disc surgery.The secondary outcomes of this study rescue medication and adverse events associated with the post-operative analgesia.

This study will be conducted under the supervision of an independent auditor. Every week, the auditor checked the data of the participants the day after the surgery was conducted. Assessment of pain intensity and prognostic outcomes must be confirmed by the auditor in sample population. When there is disagreement between surgeon and anesthesiologists in evaluating the prognosis of patients, the auditor must solve this disagreement by discussion with evaluators. Data will be double-entered by two statisticians with limitation of access and locked during statistical analysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 14, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. men or woman and 18~65 years old

2. clinical diagnosis of umbar disc herniation and will receive selective Lumbar disc surgery

Exclusion Criteria:

1. age below 18 years or over 65 years;

2. American Society of Anesthesiologists grade III or greater;

3. Diabetes;

4. allergic to local anesthetics;

5. cognitive impairment or communication problems;

6. received opioids?NSAID or tranquilizers (treatment for over 1 wk before the surgery);

7. history of alcohol or drug abuse;

8. severe hepatic or renal impairment ;

9. post-operative severe complications(e.g. pyogenic infection)

Related Conditions & MeSH terms

• Lumbar Disc Surgery
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• 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.
• Lateral TLIPB group
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Ueshima H, Hara E, Otake H. 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 Apr 25;58:12-17. doi: 10.1016/j.jclinane.2019.04.026. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acute pain post-operatively	Pain intensity will be measured by visual analogue scale(VAS)	12 hours post-operatively
Primary	Acute pain post-operatively	Pain intensity will be measured by visual analogue scale(VAS)	24 hours post-operatively
Primary	Acute pain post-operatively	Pain intensity will be measured by visual analogue scale(VAS)	36 hours post-operatively
Primary	Acute pain post-operatively	Pain intensity will be measured by visual analogue scale(VAS)	48 hours post-operatively
Secondary	Analgesic Rescue	The dosages of opioid or non-opioid analgesic rescue medications	post-operative day 1 to 2
Secondary	The number of pushed and requested PCA		post-operative day 1 to 2
Secondary	Incidence of adverse events associated with post-operative analgesia	Including inadequate analgesia; nausea and vomiting; respiratory depression; local infection	post-operative day 1 to 2