Ultrasound-Guided Quadro-Iliac Plane Block for Pain Management After Total Hip Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBursa City Hospital
About this trial
This prospective, randomized, double-blind study evaluates the analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane (QIP) block in patients undergoing primary total hip arthroplasty. The QIP block is a recently described fascial plane block. Patients will be randomized to receive either a QIP block with local anesthetic or a sham block with saline. The primary outcome is 24-hour opioid consumption. Secondary outcomes include motor block, dermatomal sensory assessment, pain scores, rescue analgesic requirement, quality of recovery (QoR-15), and opioid-related side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) classification I-III
Age between 18 and 80 years
Patients scheduled for elective primary total hip arthroplasty
Disqualifiers
Refusal to participate in the study
Allergy to local anesthetics or opioids
Known or suspected coagulopathy
Infection at the injection site
Trial design
Design model
Parallel
Treatments tested in this trial
Quadro-Iliac Plane (QIP) Block
Procedure/SurgeryAn ultrasound-guided Quadro-Iliac Plane block performed in the preoperative period. At the level of the iliac crest, 40 mL of a solution containing 0.25% levobupivacaine and 5 µg/mL epinephrine is injected into the fascial plane between the erector spinae muscle and the quadratus lumborum muscle under aseptic conditions.
Sham Block
Procedure/SurgeryA sham block performed using the same ultrasound-guided technique in the preoperative period. At the level of the iliac crest, 40 mL of 0.9% NaCl is injected into the fascial plane between the erector spinae muscle and the quadratus lumborum muscle under aseptic conditions.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Quadro-Iliac Plane (QIP) BlockExperimental treatment 1 intervention
Group B: Sham Block (Control)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative 24-Hour Morphine PCA Consumption
Total amount of morphine delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg).
Time frame
Postoperative 24 hoursSecondary outcomes
1
NRS Pain Scores at Rest and Movement
Postoperative pain will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Time frame
2, 6, 12, 24, and 48 hours postoperatively2
QoR-15 Recovery Score
The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionnaire. 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 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 \[Total score range: 0-150 points\]
Time frame
QoR-15 Recovery Score will be evaluated at the postoperative 48th hour3
Lower Extremity Muscle Strength Score
Postoperative lower extremity muscle strength will be assessed at the 6th postoperative hour using a 0-5 grading scale, where 0 indicates no muscle contraction and 5 indicates normal strength. The scale is defined as follows: 0 = no muscle contraction 1. = muscle contraction present without joint movement 2. = movement without overcoming gravity 3. = movement against gravity without resistance 4. = movement against partial resistance 5. = movement against full resistance (normal strength)
Time frame
Postoperative 6th and 12th hours4
Rescue Analgesic Requirement
Number of patients requiring rescue analgesia (IV meperidine 0.5 mg/kg) and total dose administered when NRS ≥ 4.
Time frame
Postoperative 0-48 hoursSponsors and contacts
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Source ClinicalTrials.gov