Bursa City Hospital
Bursa, 16110, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07354581
Lumbar instrumentation surgery is associated with significant postoperative pain. This study compares the postoperative analgesic effectiveness of ultrasound-guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in patients undergoing lumbar instrumentation surgery.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Bursa, 16110, Turkey (Türkiye)
Location status: Recruiting
Lumbar instrumentation surgery is frequently associated with moderate to severe postoperative pain, which may negatively affect patient comfort, delay mobilization, and increase opioid consumption. Effective postoperative analgesia is therefore essential for improving recovery and reducing opioid-related adverse effects. Regional anesthesia techniques have become an important component of multimodal analgesia strategies in lumbar spine surgery.
The Erector Spinae Plane Block (ESPB) is a well-established ultrasound-guided regional anesthesia technique that has been shown to provide postoperative analgesia in various spinal procedures. The Quadro-Iliac Plane Block (QIPB) is a newly developed ultrasound-guided block targeting the fascial plane between the erector spinae muscle and the quadratus lumborum muscle at the level of the iliac crest, with the potential to provide effective analgesia for lumbar spine surgeries. However, comparative clinical data regarding the analgesic effectiveness of these two techniques in lumbar instrumentation surgery are limited.
This study is designed to compare the postoperative analgesic effectiveness of ultrasound-guided ESPB and QIPB in patients undergoing elective lumbar instrumentation surgery under general anesthesia. Both blocks will be performed using ultrasound guidance as part of a standardized multimodal analgesia protocol.
The findings of this study aim to clarify the relative effectiveness of ESPB and QIPB for postoperative pain control following lumbar instrumentation surgery and to contribute to evidence-based selection of regional analgesia techniques in lumbar spine procedures.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An ultrasound-guided Erector Spinae Plane Block will be performed at the end of surgery, before extubation, with the patient in the prone position under standard sterilization conditions. The ultrasound probe will be placed in the parasagittal plane at the level corresponding to the surgical site to visualize the transverse process and erector spinae muscle. Following confirmation of correct needle placement with 2 mL of normal saline, 20 mL of 0.25% bupivacaine will be injected into the fascial plane deep to the erector spinae muscle. The block will be performed bilaterally, with a total volume of 40 mL, as part of a standardized multimodal postoperative analgesia protocol.
An ultrasound-guided Quadro-Iliac Plane Block will be performed at the end of surgery, before extubation, with the patient in the prone position under standard sterilization conditions. A convex ultrasound probe will be placed at the level where the quadratus lumborum muscle attaches to the iliac crest to visualize the erector spinae muscle and the underlying quadratus lumborum muscle. The block location will be confirmed with the injection of 2 mL of isotonic solution, followed by the injection of 20 mL of 0.25% bupivacaine. The spread of the local anesthetic between the erector spinae muscle and quadratus lumborum muscle will be observed under ultrasound guidance. The block will be performed bilaterally, with a total volume of 40 mL, as part of a standardized multimodal postoperative analgesia protocol.
Time frame: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams (mg).
Time frame: Postoperative 24th and 48th hours
The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre
PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent])
Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being
PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed
Time frame: 0, 2, 4, 8, 16, 24, and 48 hours postoperatively]
Numeric Rating Scale (NRS) (0-10; 0= no pain, 10= the most severe pain felt ) pain scores at rest or movement at predefined postoperative hours
Time frame: Postoperative 24th and 48th hours
Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered as rescue analgesia.
Total amount of meperidin during the first 24 and 48 hours after surgery, recorded in milligrams (mg).
Time frame: Postoperative 48 hours
Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered as rescue analgesia.
Time frame: The time from the end of the surgery to discharge from the hospital(day)
Length of hospital stay will be defined as the number of days from the end of surgery to hospital discharge.
Time frame: Postoperative 48 hours
Block- and opioid-related adverse effects and complications, including but not limited to local anesthetic toxicity, hematoma, infection, nerve injury, nausea, vomiting, pruritus, sedation, and respiratory depression, will be recorded
Contact information is provided by the study sponsor or research team.
Merih Yildiz Eglen, MD
CONTACT
Mursel Ekinci, Assoc prof MD
CONTACT
Bursa City Hospital
Other Gov
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block for Postoperative Analgesia Management Following Lumbar Instrumentation Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07731295
Chemically-Induced Disorders, Mental Disorders
Providence, Rhode Island, United States
View Trial DetailsNCT07517679
Neurologic Manifestations, Pain
Lexington, Kentucky, United States
View Trial DetailsNCT07689461
Anxiety, Anxiety Disorders
Malatya, Turkey (Türkiye)
View Trial DetailsNCT06664177
Hernia, Hernia, Abdominal
Istanbul, Turkey (Türkiye)
View Trial Details