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guidance, and once the needle touches the transverse process, it will be withdrawn by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.