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

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ClinicalTrials.gov Identifier: NCT03951038
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Min Su, First Affiliated Hospital of Chongqing Medical University

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Lumbar Disc Surgery Procedure: PCIA group Procedure: Lateral TLIPB group Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : February 14, 2020

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 Name: Nerve block




Primary Outcome Measures :
  1. 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.

  2. Acute pain post-operatively [ Time Frame: 12 hours post-operatively ]
    Pain intensity will be measured by visual analogue scale(VAS)

  3. Acute pain post-operatively [ Time Frame: 24 hours post-operatively ]
    Pain intensity will be measured by visual analogue scale(VAS)

  4. Acute pain post-operatively [ Time Frame: 36 hours post-operatively ]
    Pain intensity will be measured by visual analogue scale(VAS)

  5. Acute pain post-operatively [ Time Frame: 48 hours post-operatively ]
    Pain intensity will be measured by visual analogue scale(VAS)


Secondary Outcome Measures :
  1. Analgesic Rescue [ Time Frame: post-operative day 1 to 2 ]
    The dosages of opioid or non-opioid analgesic rescue medications

  2. The number of pushed and requested PCA [ Time Frame: post-operative day 1 to 2 ]
  3. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951038


Contacts
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Contact: Dong Zhang, Master +86-23-89011061 848138113@qq.com

Locations
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China, Chongqing
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Contact: Su Min, MD    +86-23-89011068    ms89011068@163.com   
Contact: Dong Zhang, Master    +86-23-89011061    848138113@qq.com   
Sponsors and Collaborators
First Affiliated Hospital of Chongqing Medical University
Investigators
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Principal Investigator: Su Min, MD First Affiliated Hospital of Chongqing Medical University

Publications:

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Responsible Party: Min Su, Clinical Professor, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03951038    
Other Study ID Numbers: CQMUAZD2019
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Min Su, First Affiliated Hospital of Chongqing Medical University:
Lumbar disc herniation
Postoperative analgesia
Patient controlled intravenous analgesia
Nerve block
thoracolumbar
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Flurbiprofen axetil
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents