Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadro-Iliac Plane (QIP) Block | Experimental | Participants in this arm will receive the standard analgesia protocol used for patients undergoing total hip arthroplasty. In addition to this standard regimen, an ultrasound-guided Quadro-Iliac Plane (QIP) block will be performed in the preoperative period with the patient in the lateral decubitus position. The technique aims to provide postoperative analgesia by achieving sensory blockade in the relevant dermatomal areas. |
|
| Sham Block (Control) | Placebo Comparator | Participants in this arm will receive the standard analgesia protocol used for patients undergoing total hip arthroplasty. In addition to this standard regimen, a sham block will be performed using the same ultrasound-guided technique and patient positioning to mimic the block procedure without providing active regional anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadro-Iliac Plane (QIP) Block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2, 6, 12, 24, and 48 hours postoperatively |
| QoR-15 Recovery Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mursel Ekinci, Assoc prof,MD | Contact | +905067137596 | drmurselekinci@gmail.com | |
| Mustafa Dikici, MD | Contact | +905055346540 | mus.dikici88@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa City Hospital | Recruiting | Bursa | 16110 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29026331 | Background | Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017. | |
| 35705263 | Background | Carella M, Beck F, Piette N, Denys S, Kurth W, Lecoq JP, Bonhomme VL. Effect of suprainguinal fascia iliaca compartment block on postoperative opioid consumption and functional recovery in posterolateral-approached total hip arthroplasty: a single-blind randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 15:rapm-2021-103427. doi: 10.1136/rapm-2021-103427. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
The study solutions will be prepared by an anesthesiologist who is not involved in patient care or data collection. The anesthesiologist performing the block and the patient will be blinded to group allocation. Postoperative assessments will be performed by an independent anesthesiologist who is also blinded
|
|
| Sham Block | Procedure | 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. |
|
|
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]
| QoR-15 Recovery Score will be evaluated at the postoperative 48th hour |
| 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
| Postoperative 6th and 12th hours |
| Rescue Analgesic Requirement | Number of patients requiring rescue analgesia (IV meperidine 0.5 mg/kg) and total dose administered when NRS ≥ 4. | Postoperative 0-48 hours |
| Opioid-Related Side Effects | 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. | Postoperative 0-48 hours |
| 40145906 | Background | Marrone F, Sorrentino T, Pullano C, Tulgar S. A novel and feasible option for perioperative analgesia in hip fractures surgery: quadro-iliac plane block. Minerva Anestesiol. 2025 Jun;91(6):592-595. doi: 10.23736/S0375-9393.25.18801-9. Epub 2025 Mar 27. No abstract available. |
| 38459608 | Background | Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Girit M, Akin T, Narayanan M, Alici HA. Ultrasound guided quadro-iliac plane block: another novel fascial plane block. Pain Med. 2024 May 3;25(6):370-373. doi: 10.1093/pm/pnae018. |
| 36511494 | Background | Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |