- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07237945
Quadro-Iliac Plane Block Versus Wound Infiltration for Postoperative Pain After Single-Level Lumbar Discectomy
Investigation of the Effects of Quadro-Iliac Plane Block and Wound Infiltration on Postoperative Acute Pain After Single-Level Lumbar Discectomy Surgery
This prospective observational study aims to compare the effects of the Quadro-Iliac Plane Block (QIPB) and wound infiltration (WI) on postoperative acute pain in adult patients undergoing elective single-level lumbar discectomy. QIPB is a newly introduced ultrasound-guided fascial plane block, and it is currently being used in routine clinical practice in our anesthesiology department as part of postoperative analgesia for lumbar spine surgery. Wound infiltration is a conventional method in which local anesthetic is injected into the surgical field at the end of the procedure.
In this study, eligible patients will be monitored prospectively without randomization or alteration of standard care. Postoperative pain scores, opioid consumption, nausea and vomiting, patient satisfaction, and recovery parameters will be evaluated during the first 24 hours after surgery. The study aims to provide real-world clinical evidence comparing these two analgesic techniques in lumbar discectomy patients.
Study Overview
Status
Detailed Description
This prospective observational study aims to evaluate and compare the postoperative analgesic outcomes of two routinely used analgesic techniques-Quadro-Iliac Plane Block (QIPB) and wound infiltration (WI)-in adult patients undergoing elective single-level lumbar discectomy. Both QIPB and WI are standard components of postoperative pain management in our hospital, and the type of analgesic technique administered to each patient is determined solely by the attending anesthesiologist based on routine clinical judgment. The research team does not influence clinical decision-making, perform block procedures, or modify any aspect of patient care. All interventions included in this study reflect standard institutional practice.
The primary objective is to compare cumulative opioid consumption during the first 24 hours after surgery between patients receiving QIPB and those receiving WI. Secondary objectives include evaluating postoperative pain scores, early recovery parameters, patient satisfaction, postoperative nausea and vomiting (PONV), rescue analgesic requirements, block-related complications, and hospital length of stay.
Clinical Routine and Analgesic Protocol
All patients will be managed according to the standard multimodal analgesia protocol routinely used in our neurosurgery operating room. Intraoperatively, intravenous tenoxicam 20 mg, tramadol 100 mg and dexamethasone 8 mg will be administered as part of routine analgesic and antiemetic care. Paracetamol 1 g IV will be given at the end of surgery and continued at regular intervals postoperatively. Rescue analgesia will consist of intravenous tramadol 100 mg infused over 30 minutes, with a maximum daily dose of 300 mg; if pain remains uncontrolled (NRS ≥4). All patients will receive intravenous morphine patient-controlled analgesia (Body Guard 575 Pain Manager) with a standard setting of 1 mg bolus dose, a 10-minute lockout interval, and a 4-hour limit set to 80% of the maximum allowable dose.
Block Techniques (Performed as Part of Routine Care)
QIPB Group:
QIPB is a newly introduced interfascial block technique currently used in our clinic for postoperative lumbar spine analgesia. At the end of surgery and before extubation, the patient is placed in the prone position. A low-frequency convex ultrasound probe (2-6 MHz) is positioned at the L3 midline in the transverse plane to identify the spinous process. The probe is then moved laterally and caudally to visualize the attachment of the quadratus lumborum muscle to the iliac crest. Under ultrasound guidance, a 22G, 100-mm block needle is advanced into the fascial plane between the quadratus lumborum and erector spinae muscles. A total of 60 mL of 0.25% bupivacaine (30 mL per side) is injected bilaterally. The procedure is performed by experienced anesthesiologists as part of normal clinical practice.
Wound Infiltration Group (WI):
WI is a routine analgesic method performed in our operating room. At the end of surgery, before skin closure, 20 mL of 0.25% bupivacaine is infiltrated into the surgical field in multiple tissue layers. This procedure is performed entirely according to the attending anesthesiologist's habitual clinical practice.
Postoperative Assessment
Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS; 0-10) at rest and during movement (deep breathing or coughing) at 0, 3, 6, 12, and 24 hours after surgery. PONV will be evaluated using a verbal descriptive scale. If PONV score is ≥3, 4 mg IV ondansetron will be administered. Patient satisfaction and quality of recovery will be assessed using the Turkish version of the QoR-15 questionnaire preoperatively, on postoperative day 1, and at discharge.
Block-related complications (hematoma, bleeding at the injection site, LAST), opioid-related side effects (itching, sedation, respiratory depression), time to first PCA demand, time to first mobilization, rescue analgesic requirements, and hospital length of stay will be recorded.
All data will be analyzed using SPSS software. Statistical tests will be selected based on data distribution, and a p-value < 0.05 will be considered statistically significant.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Karabük, Turkey (Türkiye), 78200
- Karabuk Training and Research Hospital, Department of Anesthesiology and Reanimation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 to 80 years
- Scheduled for elective single-level lumbar discectomy
- ASA physical status I-III
- Able to use patient-controlled analgesia (PCA)
- Able and willing to provide written informed consent
Exclusion Criteria:
- History of opioid use for longer than 4 weeks
- Presence of chronic pain before surgery (e.g., migraine, fibromyalgia)
- Alcohol or substance dependence
- Known allergy or hypersensitivity to local anesthetics or opioids
- Significant organ dysfunction (e.g., severe hepatic or renal disease)
- Revision or multilevel spine surgery
- Contraindications to regional anesthesia
- Severe psychiatric disorders limiting cooperation (e.g., psychosis, dementia)
- Pregnancy or breastfeeding
- Hematologic disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group QİPB
Patients receiving ultrasound-guided Quadro-Iliac Plane Block with 30 mL of 0.25% bupivacaine per side (total 60 mL) as part of routine postoperative analgesia after single-level lumbar discectomy.
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Group WI
Patients receiving ultrasound-guided wound infiltration with 20 mL of 0.25% bupivacaine into the surgical field at the end of surgery as part of routine postoperative analgesia after single-level lumbar discectomy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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24-hour cumulative opioid consumption
Time Frame: postoperative day 1
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Total opioid consumption within the first 24 hours, including PCA-administered morphine and rescue analgesics converted to morphine milligram equivalents (MME).
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postoperative day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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12-hour cumulative opioid consumption
Time Frame: postoperative 12th hour
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Total opioid consumption within the first 12 hours, including PCA-administered morphine and rescue analgesics converted to MME.
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postoperative 12th hour
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Block performance time
Time Frame: intraoperative period
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Total time (minutes) required to complete the QIPB procedure.
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intraoperative period
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Patient-reported quality of recovery (QoR-15 score)
Time Frame: Postoperative day 1 and at postoperative day 2-4 day
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Quality of recovery assessed using the validated 15-item QoR-15 questionnaire.
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Postoperative day 1 and at postoperative day 2-4 day
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Time to first PCA analgesic demand
Time Frame: Postoperative day 1
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Time at which the first analgesic is requested
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Postoperative day 1
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Number of patients requiring rescue analgesia
Time Frame: Postoperative day 1
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Number of patients who required rescue analgesia despite PCA use.
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Postoperative day 1
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Time to first mobilization
Time Frame: Postoperative day 2-4
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Time (hours) from the end of surgery to first assisted ambulation with a physiotherapist.
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Postoperative day 2-4
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Block-related complications
Time Frame: Postoperative day 7
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Incidence of complications such as bleeding, hematoma, or local anesthetic systemic toxicity (LAST).
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Postoperative day 7
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Opioid-related adverse effects
Time Frame: Postoperative day 7
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Presence of itching, sedation, fatigue, or respiratory depression related to opioid use.
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Postoperative day 7
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Length of hospital stay
Time Frame: Postoperative day 2-4
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Duration of hospitalization measured in hours or days.
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Postoperative day 2-4
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Postoperative pain scores (NRS at rest and activity)
Time Frame: postoperative day 1
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Pain status at rest and while activity will be assessed by numeric rating scale (NRS) score at 0, 3, 6, 12, 18 and 24 hours after surgery.
In addition, the time until the first analgesic requirement will be recorded.
The NRS is an 11-point numeric scale that ranges from 0 to 10.
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postoperative day 1
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Postoperative nausea and vomiting incidence (PONV)
Time Frame: Postoperative day 1
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The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18 and 24 hours after extubation.
If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required (The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once).
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Postoperative day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elif Sarikaya Ozel, Karabuk Training and Research Hospital, Department of Anesthesiology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- QIPB-LD2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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