Postoperative Pain, Total Hip Arthroplasty (THA)
Conditions
Keywords
PENG block, PPD block, Postoperative analgesia, Numeric Rating Scale
Brief summary
This single-center, prospective, randomized controlled clinical trial aims to compare the postoperative analgesic efficacy of PENG block with or without posterior pericapsular deep gluteal block in adult patients undergoing elective primary total hip arthroplasty under spinal anesthesia. Total hip arthroplasty is commonly associated with moderate to severe postoperative pain. Although PENG block provides analgesia for the anterior hip capsule, some patients may still experience pain originating from the posterior capsule. The addition of PPD block may improve analgesia by targeting posterior articular branches. Participants will be randomized into two groups: one group will receive PENG block, and the other group will receive PENG plus PPD block. Postoperative pain will be assessed using the Numeric Rating Scale (NRS). The study will compare postoperative pain scores and other analgesia-related outcomes between groups.
Detailed description
This study is planned as a single-center, prospective, randomized, controlled, double-blind trial in adult patients undergoing elective primary total hip arthroplasty under spinal anesthesia. Eligible participants will be patients aged 18 years or older, classified as ASA physical status I-III, and able to provide informed consent. Patients with ASA IV-V, serious cardiac, respiratory, hepatic, or renal disease, neuropsychiatric disorders, cognitive impairment preventing reliable NRS assessment, coagulopathy, local anesthetic allergy, infection or scar at the block site, failed block, signs of local anesthetic systemic toxicity, exposure to local anesthetic doses above protocol limits, revision total hip arthroplasty, fracture-related total hip arthroplasty, or refusal to participate will be excluded. Participants will be randomized by sealed-envelope method into two groups. Group 1 will receive PENG block after spinal anesthesia in the supine position using ultrasound guidance and 20 mL of 0.25% bupivacaine. Group 2 will receive PENG block followed by ultrasound-guided PPD block, with 30 mL of 0.25% bupivacaine used for the PPD block. In addition, both groups will receive lateral femoral cutaneous nerve block with 5 mL of 0.25% bupivacaine. The primary objective is to compare postoperative pain intensity between groups using Numeric Rating Scale scores. Secondary evaluations include postoperative analgesic consumption, time to first rescue analgesia, time to first mobilization, and motor function including ankle dorsiflexion strength. An initial pilot phase including 40 patients is planned, and the final sample size will be calculated using G\*Power based on pilot data with alpha 0.05 and power 0.80. The study will continue until the target sample size is reached.
Interventions
PROCEDUREPENG Block
Ultrasound-guided pericapsular nerve group block performed after spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty. In Group 1, PENG block will be performed in the supine position using an in-plane technique, and 20 mL of 0.25% bupivacaine will be injected between the psoas tendon and iliopubic ramus. In both groups, lateral femoral cutaneous nerve block will also be performed as part of the analgesic protocol.
Ultrasound-guided posterior pericapsular deep gluteal block performed after PENG block and spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty. In Group 2, the block will be performed in the lateral decubitus position with the hip and knee flexed to 90 degrees, and 30 mL of 0.25% bupivacaine will be injected after needle placement to the posterior acetabular rim near the ischiofemoral ligament using an in-plane technique.
Sponsors
Kirsehir Ahi Evran Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years and older * American Society of Anesthesiologists (ASA) physical status I-III * Scheduled for elective primary total hip arthroplasty under spinal anesthesia * Able to provide written informed consent
Exclusion criteria
* ASA physical status IV or V * Serious concomitant cardiac, respiratory, hepatic, or renal disease * Known neuropsychiatric disorder * Cognitive impairment preventing understanding or response to the Numeric Rating Scale (NRS) * Coagulopathy * Local anesthetic allergy * Infection or scar at the block site * Failed block * Refusal to participate * Signs of local anesthetic systemic toxicity after block * Patients in the PENG plus PPD group who would be exposed to a total local anesthetic dose above 3 mg/kg in patients weighing less than 50 kg * Revision total hip arthroplasty * Total hip arthroplasty planned for fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity at 6 hours measured by Numeric Rating Scale (NRS) | 6 hours after surgery | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary comparison between groups will be the NRS score at postoperative 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity over the first 24 hours measured by Numeric Rating Scale (NRS) | Recovery room, 2 hours, 12 hours, and 24 hours after surgery | Postoperative pain intensity will also be assessed in the recovery room and at postoperative 2, 12, and 24 hours using the Numeric Rating Scale (NRS) |
| Total analgesic consumption during the first 24 hours | 24 hours after surgery | Total amount of analgesic medication consumed within the first 24 hours after surgery will be recorded and compared between groups |
| Time to first rescue analgesic requirement | Up to 24 hours after surgery | Time from block performance to first additional analgesic requirement will be recorded |
| Time to first mobilization | Up to 24 hours after surgery | Time to first standing or mobilization after surgery will be recorded and compared between groups |
| Ankle dorsiflexion motor strength | Recovery room, 2 hours, 6 hours, 12 hours, and 24 hours after surgery | Ankle dorsiflexion motor strength will be assessed postoperatively to evaluate possible motor weakness related to block spread. |
Contacts
CONTACTGuzin Ceran Assistant Professor, MD
CONTACTAbdulkadir Apaydin, MD
PRINCIPAL_INVESTIGATORGuzin Ceran, MD
Kirsehir Ahi Evran University Faculty of Medicine, Kirsehir Training and Research Hospital
Outcome results
None listed