Bursa City Hospital
Bursa, 16110, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07410000
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Bursa, 16110, Turkey (Türkiye)
Location status: Recruiting
Total hip arthroplasty is associated with significant postoperative pain. The Quadro-Iliac Plane (QIP) block is a recently described fascial plane block targeting the area where the quadratus lumborum muscle attaches to the iliac crest and may provide more comprehensive analgesia. This study is designed as a prospective, randomized, double-blind clinical trial including patients aged 18-80 years with ASA physical status I-III undergoing elective primary total hip arthroplasty.
Patients will be randomized into two groups. The QIP group will receive an ultrasound-guided QIP block with 40 mL of 0.25% local anesthetic solution containing epinephrine, and the control group will receive a sham block with 40 mL of 0.9% NaCl using the same technique. The primary outcome is postoperative 24-hour opioid consumption. Secondary outcomes include motor block, and dermatomal sensory assessment, pain scores, quality of recovery (QoR-15), rescue analgesic requirement and opioid-related side effects
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An 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.
Other names: QIP Block
A 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.
Other names: Control Block
Time frame: Postoperative 24 hours
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: 2, 6, 12, 24, and 48 hours postoperatively
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: QoR-15 Recovery Score will be evaluated at the postoperative 48th hour
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: Postoperative 6th and 12th hours
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
Time frame: Postoperative 0-48 hours
Number of patients requiring rescue analgesia (IV meperidine 0.5 mg/kg) and total dose administered when NRS ≥ 4.
Time frame: Postoperative 0-48 hours
Opioid-related side effects will be assessed postoperatively
Other opioid-related side effects, including pruritus, constipation, and somnolence, will be recorded as present or absent.
Contact information is provided by the study sponsor or research team.
Mursel Ekinci, Assoc prof,MD
CONTACT
Mustafa Dikici, MD
CONTACT
Bursa City Hospital
Other Gov
Effectiveness of Ultrasound-Guided Quadro-Iliac Plane Block for Pain Management After Total Hip Arthroplasty: A Prospective Randomized Study
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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