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

May 14, 2019 updated by: Min Su, First Affiliated Hospital of Chongqing Medical University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dong Zhang, Master
  • Phone Number: +86-23-89011061
  • Email: 848138113@qq.com

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PCIA group
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
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.
EXPERIMENTAL: Lateral TLIPB group
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

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.

Other Names:
  • Nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute pain post-operatively
Time Frame: 6 hours 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
Time Frame: 12 hours post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
12 hours post-operatively
Acute pain post-operatively
Time Frame: 24 hours post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
24 hours post-operatively
Acute pain post-operatively
Time Frame: 36 hours post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
36 hours post-operatively
Acute pain post-operatively
Time Frame: 48 hours post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
48 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Rescue
Time Frame: post-operative day 1 to 2
The dosages of opioid or non-opioid analgesic rescue medications
post-operative day 1 to 2
The number of pushed and requested PCA
Time Frame: post-operative day 1 to 2
post-operative day 1 to 2
Incidence of adverse events associated with post-operative analgesia
Time Frame: post-operative day 1 to 2
Including inadequate analgesia; nausea and vomiting; respiratory depression; local infection
post-operative day 1 to 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2019

Primary Completion (ANTICIPATED)

January 31, 2020

Study Completion (ANTICIPATED)

February 14, 2020

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (ACTUAL)

May 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQMUAZD2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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