AnalgesiaNCT06933641
Regional Blocks for Lumbar Disc Surgery Analgesia
A study testing Regional Analgesia in people with Analgesia, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Regional Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 and 65 who were having elective lumbar disc herniation surgery and had ASA I-III ratings made up the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Analgesia
- Being tested
- Regional Analgesia
- Keywords
- Lumbar Vertebrae, Postoperative Pain, Nerve Block, Interfascial Plane Blocks, Analgesics, Opioid
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional AnalgesiaProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | All patients received routine intravenous analgesia with 1 g paracetamol and 1 mg/kg tramadol hydrochloride every 12 hours during postoperative ward follow-ups. |
| Paravertebral Block Group | Active comparator | 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. Receives: Procedure: Regional Analgesia |
| Thoracolumbar Interfascial Plane Block Group | Experimental | 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. Receives: Procedure: Regional Analgesia |
| Retrolaminar Block Group | Experimental | 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. Receives: Procedure: Regional Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The pain is scaled with Visual Analogue Scale score in 4 groups
Measured: 0 hour, 1 hour, 2 hour, 6 hour, 12 hour, 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Gokalp TAS, Erzincan University
- Investigators
- Hakan Gökalp Taş, Study director, Erzincan Binali Yildirim Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933641
- Sponsor's protocol ID
- 2024-07/06
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Paravertebral, Thoracolumbar Interfascial Plane, and Retrolaminar Blocks for Postoperative Analgesia in Lumbar Disc Herniation Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06933641
- Acronym / sponsor ID
- 2024-07/06
- Conditions
- Analgesia
- Keywords
- Lumbar Vertebrae, Postoperative Pain, Nerve Block, Interfascial Plane Blocks, Analgesics, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –All patients received routine intravenous analgesia with 1 g paracetamol and 1 mg/kg tramadol hydrochloride every 12 hours during postoperative ward follow-ups. |
| Paravertebral Block Group | Active comparator | Procedure: Regional AnalgesiaAll 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. |
| Thoracolumbar Interfascial Plane Block Group | Experimental | Procedure: Regional AnalgesiaAll 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. |
| Retrolaminar Block Group | Experimental | Procedure: Regional AnalgesiaAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 and 65 who were having elective lumbar disc herniation surgery and had ASA I-III ratings made up the study
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional Analgesia20 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 | Procedure or surgery | Paravertebral Block Group, Retrolaminar Block Group, Thoracolumbar Interfascial Plane Block Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
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Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Gökalp Taş study director
Erzincan Binali Yildirim Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional Analgesia in people with Analgesia, run by Erzincan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 0 hour, 1 hour, 2 hour, 6 hour, 12 hour, 24 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.