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Postoperative PainNCT06656507

Comparison of Quadro Iliac vs Erector Spinae Plane Block on Postoperative Pain and Opioid Use in Lumbar Discectomies

A study testing Quadro Iliac Plane Block (QIPB) and Erector Spinae Plane Block (ESP) in people with Postoperative Pain and Lumbar Disc Herniation, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multicenter, randomized, controlled study aims to compare the analgesic efficacy of Quadro Iliac Plane Block (QIPB) and Erector Spinae Plane (ESP) Block in lumbar vertebra surgeries. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Postoperative Pain, Lumbar Disc Herniation
What is being tested?
Quadro Iliac Plane Block (QIPB) and Erector Spinae Plane Block (ESP)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Nov 2024to 16 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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 to 65 years.
  • ASA physical status classification I-III.
  • Patients scheduled for single-level lumbar disk herniation surgery.
  • No history of bleeding diathesis.
  • No history of anticoagulant use.
  • No known allergies to the medications used in the study (e.g., bupivacaine).
  • No history of neuropathic diseases.
  • Patients who have provided informed consent to participate in the study.

Who cannot join

  • Patients younger than 18 or older than 65 years.
  • ASA physical status classification IV or higher.
  • Patients with a history of coagulopathy or bleeding disorders.
  • Patients with a history of chronic opioid use or substance abuse.
  • Patients with allergies to local anesthetics (e.g., bupivacaine).
  • Patients with significant neuropathic conditions or central nervous system disorders.
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  • Patients with any contraindication to regional anesthesia.
  • Pregnant or breastfeeding women.
  • Patients unable to provide informed consent.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

    Istanbul, 34303

  • Zincirlikuyu Medicana Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Efficacy of Quadro Iliac Plane Block and Erector Spinae Plane Block on Postoperative Pain Management and Opioid Consumption in Single Level Lumbar Discectomies: A Multicenter Randomized Controlled Trial

This multicenter, randomized, controlled study aims to compare the analgesic efficacy of Quadro Iliac Plane Block (QIPB) and Erector Spinae Plane (ESP) Block in lumbar vertebra surgeries. The study will evaluate postoperative pain management, opioid consumption, side effects, hospital stay duration, and patient satisfaction. Patients scheduled for single-level lumbar disk herniation surgery will be randomized to receive either the QIPB or ESP block before awakening from anesthesia. Pain scores will be measured at multiple postoperative time points, and opioid consumption will be monitored using patient-controlled analgesia (PCA). The study seeks to identify the most effective and safe method for postoperative pain management in lumbar surgeries.

Read the detailed description

Detailed Description: The purpose of this study is to compare the analgesic efficacy of two commonly used regional anesthesia techniques-Quadro Iliac Plane Block (QIPB) and Erector Spinae Plane (ESP) Block-in lumbar vertebra surgeries. This is a prospective, randomized, controlled, and multicenter trial. The study aims to evaluate the effectiveness of QIPB and ESP blocks in postoperative pain control, opioid consumption, side effects, hospital stay duration, and patient satisfaction. The findings are expected to contribute to identifying more effective and safer methods for postoperative pain management in lumbar spine surgeries.

This study will focus on examining the impact of these two different block techniques on pain scores, particularly during the early postoperative period. By analyzing the potential benefits and limitations of these techniques, the study will aim to provide valuable insights into postoperative pain control. Additionally, a comparative analysis of the feasibility and patient safety of both block techniques will be conducted.

Materials and Methods: Patients aged 18 and above, with ASA scores of I-III, without bleeding diathesis, no history of anticoagulant use, no history of allergies to the medications used, and no history of neuropathic disease, undergoing single-level lumbar disk herniation surgery will be included in the study. Patients will be randomized to receive either ESP or QIP block before awakening post-surgery. Informed consent will be obtained from all participants, and both blocks will be thoroughly explained.

To avoid bias, the study is designed as multicenter, and experienced anesthesiologists will perform the blocks at the end of the surgery, before the patient is awakened.

Block Techniques:

ESP Block: With a linear ultrasound probe in the transverse plane, the transverse process of the L3 vertebra will be identified. A block needle will be advanced under ultrasound guidance, and once the needle touches the transverse process, it will be withdrawn by 1mm, confirmed with sterile saline, and 50 mg (0.25%) bupivacaine will be administered bilaterally.

QIP Block: For patients in a prone position, a low-frequency convex transducer (2-6 MHz) will be placed at the midline at the L3 level in the transverse plane to identify the spinal process. Lateral movement will identify the transverse process within the erector spinae muscle. The transducer will then be rotated to the parasagittal plane and moved caudally to locate the attachment of the Quadratus Lumborum Muscle (QLM) to the iliac crest. A block needle will be advanced under ultrasound guidance, and 50 mg (0.25%) bupivacaine will be injected bilaterally into the fascia below the QLM.

Postoperative Care: Before awakening, all patients will receive 1g of paracetamol, 100mg of tramadol, and 50mg of dexketoprofen intravenously. Postoperatively, multimodal analgesia will be provided using patient-controlled analgesia (PCA) with tramadol HCl, set to deliver 20 mg boluses with a lockout interval of 20 minutes, and a maximum dose limit of 200mg over 4 hours. Pain scores will be assessed at rest and with movement at 0, 2, 6, 12, and 24 hours using the Numeric Rating Scale (NRS), ranging from 0-10. Opioid consumption and the need for rescue analgesia (50 mg dexketoprofen in 100cc saline over 20 minutes) will also be evaluated. Routine administration of 1g of intravenous paracetamol will be given at 6 hours postoperatively.

Sample Size and Statistical Methods: A power analysis with an alpha error of 0.05, power of 0.8, and effect size of 0.8 determined that at least 26 patients per group (total 52) are needed. Accounting for potential errors, 60 patients will be enrolled in the study. Data will be analyzed using IBM SPSS 21. Descriptive statistics will be computed for each variable, with continuous data presented as mean ± standard deviation or median (IQR), and categorical data as frequencies and percentages. The Shapiro-Wilk test will be used to assess normality, and non-parametric tests will be applied if the data are not normally distributed.

Between-group comparisons of continuous data will use independent t-tests or Mann-Whitney U tests, depending on normality. Categorical variables will be compared using the Chi-square test or Fisher's Exact Test. Primary outcomes, including NRS pain scores at rest at 24 hours, will be analyzed using t-tests or Mann-Whitney U tests. Secondary outcomes, such as opioid consumption, nausea, vomiting, and motor block, will be analyzed similarly. Rescue analgesia need will be analyzed with the Chi-square test. A p-value of <0.05 will be considered statistically significant.

This study aims to provide crucial information on the efficacy and safety of both block techniques, potentially improving postoperative pain management practices in lumbar spine surgeries.

Being tested
Quadro Iliac Plane Block (QIPB), Erector Spinae Plane Block (ESP)
Medical subject headings
Pain, Postoperative, Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quadro Iliac Plane Block (QIPB)Procedure or surgery

    The Quadro Iliac Plane Block (QIPB) will be performed pre-awakening in patients undergoing lumbar vertebra surgeries. Using a low-frequency convex ultrasound transducer (2-6 MHz), the spinal process will be identified at the L3 level in a prone-positioned patient. The transducer will be moved laterally to locate the transverse process within the erector spinae muscle and then rotated to the parasagittal plane to identify the Quadratus Lumborum Muscle (QLM) attachment to the iliac crest. A 22G x 100 mm block needle will be advanced under ultrasound guidance, and 50 mg (0.25%) bupivacaine will be injected bilaterally into the fascia beneath the QLM. This technique is designed to provide effective postoperative pain control by blocking the nerves in the quadratus lumborum plane.

  • Erector Spinae Plane Block (ESP)Procedure or surgery

    The Erector Spinae Plane Block (ESP) will also be performed pre-awakening. A linear ultrasound probe will be placed transversely at the level of the L3 vertebra to visualize the transverse process. A block needle will be advanced under ultrasound guidance until it touches the transverse process, after which the needle will be withdrawn 1 mm. Fifty milligrams (0.25%) bupivacaine will then be administered bilaterally. The ESP block aims to provide postoperative analgesia by blocking sensory nerves in the erector spinae plane.

Study groups in NCT06656507
Study groupRoleWhat they receive
Quadro Iliac Plane Block (QIPB) ArmExperimentalPatients in this arm will receive the Quadro Iliac Plane Block (QIPB) before awakening from lumbar vertebra surgery. Patients in this arm will receive the Quadro Iliac Plane Block (QIPB) before awakening from lumbar vertebra surgery. The patient will be placed in a prone position, and a low-frequency convex ultrasound transducer (2-6 MHz) will be used. The transducer will be placed in the midline at the L3 level in the transverse plane to identify the spinal process. After lateral movement, the transverse process within the erector spinae muscle will be visualized. The transducer will then be rotated to the parasagittal plane and moved caudally to identify the attachment of the Quadratus Lumborum Muscle (QLM) to the iliac crest. A 22G x 100 mm peripheral nerve block needle (Stimuplex® Ultra 360®, B-Braun, USA) will be advanced under ultrasound guidance, and 50 mg (0.25%) bupivacaine will be injected bilaterally into the fascia below the QLM.
Receives: Procedure: Quadro Iliac Plane Block (QIPB)
Erector Spinae Plane Block (ESP) ArmExperimentalPatients in this arm will receive the Erector Spinae Plane Block (ESP) before awakening from lumbar vertebra surgery. Patients in this arm will receive the Erector Spinae Plane Block (ESP) before awakening from lumbar vertebra surgery. A linear ultrasound probe will be placed transversely over the L3 vertebra to visualize the transverse process. A block needle (Stimuplex® Ultra 360®, B-Braun, USA) will be advanced under ultrasound guidance until it contacts the transverse process. After withdrawing the needle by 1 mm, 50 mg (0.25%) bupivacaine will be injected bilaterally.
Receives: Procedure: Erector Spinae Plane Block (ESP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NRS Score

    Postoperative pain assessed by numerical rating scale (NRS) (0-10)

    Measured: 24 hours

Secondary outcomes (3)
  1. PCA

    PCA(patient controlled analgesia) opioid consumption

    Measured: 24 hours

  2. Rescue analgesia

    Number of participant need rescue analgesia requirement (deksketoprofen 50mg)

    Measured: 24 hours

  3. Side effects

    Side effects (nausea, vomiting, motor block)

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start1 Nov 2024
  3. Primary completion15 Jan 2025
  4. Study completion16 Jan 2025

Resources

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
Model description
This study follows a Parallel Assignment model where eligible patients undergoing lumbar vertebra surgeries will be randomized into one of two groups. One group will receive the Quadro Iliac Plane Block (QIPB), while the other group will receive the Erector Spinae Plane (ESP) Block. Both interventions will be administered pre-awakening following surgery, with each group receiving only their assigned block. The groups will be assessed independently for postoperative pain control, opioid consumption, side effects, and overall patient satisfaction. This parallel approach ensures that each group's treatment and outcomes are evaluated without crossover, allowing for a direct comparison of the two regional anesthesia techniques.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656507
Sponsor's protocol ID
qip-esp/ldh
Status last verified
Jan 2025
First submitted
22 Oct 2024
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Quadro Iliac Plane Block (QIPB) and Erector Spinae Plane Block (ESP) in people with Postoperative Pain and Lumbar Disc Herniation, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites 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 8 inclusion and 9 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 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

NRS Score (time frame: 24 hours). 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 22 Jan 2025.

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