Clinical trial NCT06933641: Regional Blocks for Lumbar Disc Surgery Analgesia
Official title: Comparison of Paravertebral, Thoracolumbar Interfascial Plane, and Retrolaminar Blocks for Postoperative Analgesia in Lumbar Disc Herniation Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: Lumbar Vertebrae
Postoperative Pain
Nerve Block
Interfascial Plane Blocks
Analgesics, Opioid
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 0 hour, 1 hour, 2 hour, 6 hour, 12 hour, 24 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan University
state: Merkez
Study officials:
affiliation: Erzincan Binali Yildirim Universitesi
name: Hakan Gökalp Taş
role: STUDY_DIRECTOR
References: