Bursa City Hospital
Nilufer, Bursa, 16110, Turkey (Türkiye)
NCT Number: NCT07370415
Lumbar instrumentation surgery is associated with severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction during the procedure. Inadequate postoperative pain control may result in delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay. Ultrasound-guided regional analgesia techniques are increasingly used to improve postoperative pain management after lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block has been shown to provide effective analgesia for lumbar instrumentation surgery, and its modified technique (mTLIP) has been reported to enhance postoperative pain control. The quadro-iliac plane (QIP) block is a newly described fascial plane block with promising results in lumbar spine surgery. This randomized controlled trial aims to compare the postoperative analgesic effectiveness of the modified thoracolumbar interfascial plane block and the quadro-iliac plane block in patients undergoing lumbar instrumentation surgery.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Nilufer, Bursa, 16110, Turkey (Türkiye)
Lumbar instrumentation surgery is commonly associated with moderate-to-severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction. Inadequate pain control may lead to delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay.
Ultrasound-guided regional analgesia techniques, particularly fascial plane blocks, are increasingly used as part of multimodal analgesia in lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block is an established technique that provides effective analgesia and has been modified to improve its clinical application, resulting in the modified thoracolumbar interfascial plane (mTLIP) block. Previous studies have demonstrated the effectiveness of mTLIP for postoperative analgesia after lumbar instrumentation surgery.
The quadro-iliac plane block (QIPB) is a recently described ultrasound-guided fascial plane block. Early reports suggest that QIPB may provide effective analgesia in lumbar spine procedures; however, comparative evidence with established techniques remains limited.
This prospective randomized controlled trial aims to compare bilateral ultrasound-guided mTLIP and QIPB performed at the end of surgery in patients undergoing elective lumbar instrumentation surgery under general anesthesia, to evaluate whether QIPB can be considered a safe and effective alternative to mTLIP for postoperative analgesia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected into the interfascial plane between the longissimus and iliocostalis muscles at the operated lumbar levels. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).
An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected at the point where the quadratus lumborum muscle attaches to the iliac crest, allowing spread between the erector spinae and quadratus lumborum muscles. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).
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 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.
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: Patients will remain under observation for at least 2 weeks until their postoperative discharge. Follow-up will be completed upon discharge. The length of hospital stay will be recorded.
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 Modified Thoracolumbar Interfascial Plane Block Versus Quadro-Iliac Plane Block for Postoperative Analgesia After Lumbar Instrumentation Surgery
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