Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656507
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Comparison of Quadro Iliac vs Erector Spinae Plane Block on Postoperative Pain and Opioid Use in Lumbar Discectomies
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 025 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 025 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 005 power of 08 and effect size of 08 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 Fishers 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 005 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
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 025 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 025 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 005 power of 08 and effect size of 08 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 Fishers 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None