About this trial
The goal of this clinical trial is to compare the PENG block with intrathecal morphine for early postoperative recovery and pain control in adults undergoing elective total hip arthroplasty. The main question it aims to answer is:
Is there a difference between PENG block and intrathecal morphine in quality of recovery 24 hours after surgery, as measured by the Quality of Recovery-15 (QoR-15) questionnaire?
Researchers will also compare postoperative pain, opioid use, mobilization, motor function, and treatment-related side effects between the two groups.
Participants will be randomly assigned to receive either a PENG block or intrathecal morphine in addition to spinal anesthesia and standard multimodal pain treatment. Participants will complete the QoR-15 questionnaire before surgery and 24 hours after surgery. Pain scores, opioid use, mobilization, motor function, and side effects will be assessed during the first 24 hours after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-85 years
American Society of Anesthesiologists (ASA) physical status I-III
Scheduled for elective primary unilateral total hip arthroplasty
Planned spinal anesthesia
Disqualifiers
Contraindication to spinal anesthesia or PENG block
Known allergy or hypersensitivity to local anesthetics or morphine
Coagulation disorder
Therapeutic anticoagulant use
Trial design
Parallel
Treatments tested in this trial
Pericapsular nerve group (PENG) block
Procedure/SurgeryParticipants will receive an ultrasound-guided pericapsular nerve group (PENG) block after spinal anesthesia. The total injectate volume will be 20 mL, with an intended dose of 100 mg bupivacaine (20 mL of 0.5% bupivacaine). The bupivacaine dose will be reduced when necessary to ensure that the total bupivacaine dose, including the dose administered for spinal anesthesia, does not exceed 2 mg/kg. When dose reduction is required, 0.9% saline will be added to maintain a total injectate volume of 20 mL.
Intrathecal Morphine
Drug100 micrograms of preservative-free morphine administered intrathecally during spinal anesthesia
Treatment groups
Trial outcomes
Primary outcomes
Quality of Recovery-15 (QoR-15) Score at 24 Hours After Surgery
Quality of recovery will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery. The questionnaire will be administered preoperatively to assess baseline recovery status and repeated 24 hours after surgery. The primary outcome will be the QoR-15 score at 24 hours after surgery.
Secondary outcomes
Pain at Rest Assessed by the Numeric Rating Scale (NRS)
Pain at rest will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A preoperative measurement will be obtained as the baseline value, and postoperative measurements will be compared with baseline and between the study groups.
Pain During Straight Leg Raise Assessed by the Numeric Rating Scale (NRS)
Pain during active straight leg raise will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A preoperative measurement will be obtained as the baseline value, and postoperative measurements will be compared with baseline and between the study groups.
Cumulative Postoperative Opioid Consumption
Total opioid consumption during the first 24 hours after surgery will be recorded. Administered opioids will be converted to intravenous morphine-equivalent doses for comparison between groups.
Time to First Postoperative Mobilization
Time from the end of surgery to the participant's first postoperative mobilization will be recorded.
Sponsors and contacts
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Erzincan Binali Yildirim Universitesi
Lead sponsor
Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
Sponsor institution
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