Regional Blocks for Lumbar Disc Surgery Analgesia

April 10, 2025 updated by: Hakan Gokalp TAS, Erzincan University

Comparison of Paravertebral, Thoracolumbar Interfascial Plane, and Retrolaminar Blocks for Postoperative Analgesia in Lumbar Disc Herniation Surgery: A Randomized Controlled Trial

Objective The goal of this prospective randomized controlled experiment was comparing the analgesic efficacy, opioid needs, and adverse effect profiles of Paravertebral Block (PVB), Thoracolumbar Interfascial Plane Block (TLIP), and Retrolaminar Block (RLB) in patients undergoing lumbar disc herniation surgery.

Methods 180 adults (ASA I-III) undergoing elective lumbar disc herniation surgery made up this single-center study. Among the exclusion criteria were coagulation problems, injection site infection, allergy to local anesthetics, and incapacity to provide informed consent. Patients were randomly assigned into four groups: Control (systemic analgesia only), PVB, TLIP, and RLB (45 patients per group). An expert anesthesiologist supervised the ultrasonography during each block. The Visual Analog Scale (VAS) was used to measure postoperative pain at 0, 1, 2, 6, 12, and 24 hours after surgery. This was the primary outcome. Motor block incidence, rescue morphine consumption, and Quality of Recovery-40 (QoR-40) scores at 24 hours were secondary objectives. Unfavorable incidents were noted. ANOVA and Kruskal-Wallis tests (p<0.05) were used to examine the data.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Detailed Description

With an annual frequency of 10% to 15% among healthy adults, low back pain is a significant global public health concern. For low back pain, the typical visual analog scale (VAS) score is approximately 4, indicating moderate pain severity (1). A common cause of back and leg pain is intervertebral disc herniation, which causes throbbing anguish in the lower extremities along with radicular pain. Lumbar disc surgery is a common procedure for people with moderate to severe back pain and radicular symptoms. Surgery may be necessary for people with chronic symptoms, neurological deficits, or inadequate pain relief with conservative treatment, even though acute intervertebral disc herniation often resolves on its own without surgery.

After lumbar disc herniation surgery, postoperative pain management is still crucial since inadequate pain management can lead to prolonged hospital stays, slower recovery, and a poorer quality of life. Numerous strategies have been used to manage postoperative pain, such as regional anesthetic procedures, epidural steroid injections, nonsteroidal anti-inflammatory drugs (NSAIDs), and even unconventional methods like electroacupuncture. Due of their capacity to provide targeted pain relief while minimizing systemic effects, regional anesthetic procedures have become increasingly popular among these.

In lumbar surgery, the paravertebral block (PVB) is a common regional anesthetic technique. A local anesthetic is injected close to the spinal nerves, and it typically relieves pain over four dermatomes (two above and two below the injection site). Patients with spinal anomalies or those for whom neuraxial anesthesia is contraindicated have been shown to benefit greatly from PVB. Additionally, it differs from other peripheral nerve blocks in its ability to reduce visceral and somatic pain. However, PVB requires technical know-how and might have negative effects like vascular injury and pneumothorax, particularly when performed by unskilled professionals.

PVB is being replaced by more recent truncal block methods such retrolaminar blocks (RLB) and the thoracolumbar interfascial plane (TLIP). For effective analgesia during lumbar spine surgery, the TLIP block targets the thoracolumbar fascia. According to recent studies, the TLIP block can enhance recovery quality, decrease postoperative pain levels, and lessen the need for rescue medications. In a similar vein, the RLB, which involves administering a local anesthetic into the retrolaminar area, has been associated with shorter recovery periods, reduced postoperative pain scores, and decreased narcotic usage. Compared to PVB, these contemporary techniques are less invasive, simpler to do under ultrasound guidance, and possibly less problematic.

Comparative research is required to evaluate the effectiveness, safety, and viability of TLIP and RLB in the setting of lumbar disc herniation surgery, given their increasing popularity as PVB substitutes. Previous research has primarily focused on the individual efficacy of these methods; however, head-to-head comparisons remain limited. The aim of this study is to investigate at the analgesic efficacy, sensory coverage, and side effect profiles of PVB, TLIP, and RLB in patients having lumbar disc herniation surgery. By doing so, we intend to determine if TLIP and RLB are viable alternatives to PVB, particularly in terms of side effects and patient recovery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Turkey
    • Merkez
      • Erzincan, Merkez, Turkey, 24000
        • Erzincan University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 and 65 who were having elective lumbar disc herniation surgery and had ASA I-III ratings made up the study

Exclusion Criteria:

  • The study excluded patients having a history of opioid dependency, coagulation issues, difficult behavior, pharmaceutical allergies, prior spinal surgery, or unwillingness to participate in the experiment

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
All patients received routine intravenous analgesia with 1 g paracetamol and 1 mg/kg tramadol hydrochloride every 12 hours during postoperative ward follow-ups.
Active Comparator: Paravertebral Block Group
All patients received regional analgesia and routine intravenous analgesia with 1 g paracetamol and 1 mg/kg tramadol hydrochloride every 12 hours during postoperative ward follow-ups.
Procedure: Regional Analgesia
20 cc of local anesthetic solution, comprising 10 cc of 0.5% bupivacaine and 10 cc of 0.9% NaCl bilaterally, was injected into each side once
Experimental: Thoracolumbar Interfascial Plane Block Group
All patients received regional analgesia and routine intravenous analgesia with 1 g paracetamol and 1 mg/kg tramadol hydrochloride every 12 hours during postoperative ward follow-ups.
Procedure: Regional Analgesia
20 cc of local anesthetic solution, comprising 10 cc of 0.5% bupivacaine and 10 cc of 0.9% NaCl bilaterally, was injected into each side once
Experimental: Retrolaminar Block Group
All patients received regional analgesia and routine intravenous analgesia with 1 g paracetamol and 1 mg/kg tramadol hydrochloride every 12 hours during postoperative ward follow-ups.
Procedure: Regional Analgesia
20 cc of local anesthetic solution, comprising 10 cc of 0.5% bupivacaine and 10 cc of 0.9% NaCl bilaterally, was injected into each side once

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 0 hour, 1 hour, 2 hour, 6 hour, 12 hour, 24 hour after surgery
The pain is scaled with Visual Analogue Scale score in 4 groups
0 hour, 1 hour, 2 hour, 6 hour, 12 hour, 24 hour after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erzincan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hakan Gökalp Taş, Erzincan Binali Yildirim Universitesi

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-07/06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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