US-Guided Quadro-Iliac Plane Block for Postoperative Analgesia After Lumbar Instrumentation
ConditionPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBursa City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Classified as American Society of Anesthesiologists (ASA) physical status I-III
Scheduled for elective lumbar instrumentation surgery
Surgery performed under general anesthesia
Provision of written informed consent
Disqualifiers
Use of anticoagulant or antiplatelet medications
Presence of bleeding diathesis or coagulation disorders
Known allergy or hypersensitivity to local anesthetics or opioid medications
Infection at the planned block site
Trial design
Design model
Parallel
Treatments tested in this trial
Quadro-Iliac Plane Block
Procedure/SurgeryUltrasound-guided regional anesthesia technique performed between the erector spinae muscle and the quadratus lumborum muscle at the iliac crest level.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Group QIPBActive comparator 1 intervention
Group B: Group ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Postoperative 48-Hour PCA Opioid Consumption
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 0-8, 8-16, 16-24, 24-48 intervals2
QoR-15 Recovery Score
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
Postoperative 24th and 48th hoursSecondary outcomes
1
Dynamic and static NRS scores
Numeric Rating Scale (NRS) (0-10) pain scores at rest or movement at predefined postoperative hours
Time frame
0, 2, 4, 8, 16, 24, and 48 hours postoperatively2
Total rescue analgesic dose
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 24th and 48th hours3
Time of first request for rescue analgesia
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
Postoperative 48-Hours4
Length of Hospital Stay
Length of hospital stay will be defined as the number of days from the end of surgery to hospital discharge.
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).Sponsors and contacts
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Source ClinicalTrials.gov