Bursa City Hospital
Bursa, 16110, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07370428
Lumbar instrumentation surgery is associated with significant postoperative pain. This study evaluates the analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane Block in patients undergoing lumbar instrumentation surgery, aiming to assess the efficacy of this newly developed technique for postoperative pain management.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Bursa, 16110, Turkey (Türkiye)
Location status: Recruiting
Lumbar instrumentation surgery is associated with significant postoperative pain, which may reduce patient comfort, delay early mobilization, and increase analgesic requirements. Effective postoperative pain management is essential for enhancing recovery and reducing postoperative morbidity. In this context, regional anesthesia techniques have become an important component of multimodal analgesia strategies.
The Quadro-Iliac Plane Block is a newly described ultrasound-guided regional analgesia technique. This block aims to provide effective analgesia by targeting the relevant branches of the lumbar nerves supplying the surgical area. However, clinical evidence regarding its effectiveness in postoperative analgesia following lumbar instrumentation surgery remains limited.
This study aims to evaluate the postoperative analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane Block in patients undergoing lumbar instrumentation surgery. The findings of this study are expected to contribute to the assessment of this newly developed technique as a safe and effective option for postoperative pain management in lumbar spine surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided regional anesthesia technique performed between the erector spinae muscle and the quadratus lumborum muscle at the iliac crest level.
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) 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: 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 (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 Yıldız Eglen, MD
CONTACT
Mursel Ekinci, Assoc prof,MD
CONTACT
Bursa City Hospital
Other Gov
Evaluation of the Effectiveness of Ultrasound-Guided Quadro-Iliac Plane Block in Postoperative Analgesia Management Following Lumbar Instrumentation Surgery
Acronym: QIPB
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.
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