PENG Block With Dexmedetomidine in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorPoznan University of Medical Sciences
About this trial
Pain after hip surgery is a common problem in older adults and may delay early mobilization, increase the need for opioid pain medications, and contribute to complications such as delirium, nausea, or prolonged hospital stay. Regional anesthesia techniques are increasingly used to improve pain control while reducing the use of systemic opioids.
The pericapsular nerve group (PENG) block is a modern ultrasound-guided regional anesthesia technique designed to provide effective pain relief after hip surgery while preserving muscle strength. It allows patients to begin mobilization earlier and may reduce the risk of postoperative complications, which is particularly important in older adults.
Ropivacaine is a commonly used local anesthetic for nerve blocks. Dexmedetomidine is a medication that, when added in small doses to local anesthetics, may prolong pain relief and improve the quality of nerve blocks without significantly increasing side effects. However, the benefits and safety of adding dexmedetomidine to the PENG block in older adults have not been sufficiently studied.
The aim of this randomized controlled clinical study is to compare the effectiveness and safety of two PENG block techniques in older adults undergoing hip surgery. Participants will be randomly assigned to one of two groups. One group will receive a PENG block with 20 mL of 0.2% ropivacaine. The second group will receive a PENG block with 20 mL of 0.2% ropivacaine combined with 25 micrograms of dexmedetomidine.
The study hypothesis is that the addition of dexmedetomidine to ropivacaine in the PENG block will provide longer-lasting and more effective postoperative pain relief compared with ropivacaine alone, without increasing adverse effects. Outcomes assessed in the study will include postoperative pain intensity, need for additional pain medications, time to first mobilization, and the occurrence of side effects such as low blood pressure, slow heart rate, excessive sedation, or delirium.
The results of this study may help optimize regional anesthesia techniques for hip surgery in older adults and contribute to safer, more effective postoperative pain management strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 65 years or older
Scheduled for elective or emergency hip surgery (e.g., hip fracture fixation or hip arthroplasty)
ASA physical status I-III
Ability to communicate pain intensity using the NRS scale
Disqualifiers
Patient refusal or inability to provide informed consent
Allergy, intolerance, or contraindication to any study medication: ropivacaine, dexmedetomidine
Pre-existing neurological deficit or neuropathy of the affected limb
Coagulopathy (INR >1.5, platelets <100,000/µL) or current therapeutic anticoagulation that contraindicates regional anesthesia
Trial design
Design model
Parallel
Treatments tested in this trial
Ropivacaine 0.2% Injectable Solution
DrugRopivacaine is a long-acting local anesthetic used for regional anesthesia. In this study, it is administered perineurally as part of an ultrasound-guided pericapsular nerve group (PENG) block for postoperative pain management in older adults undergoing hip surgery.
Dexmedetomidine
DrugDexmedetomidine is a selective alpha-2 adrenergic agonist used as an adjuvant to local anesthetics to enhance and prolong analgesia. In this study, dexmedetomidine is administered perineurally in combination with ropivacaine as part of an ultrasound-guided pericapsular nerve group (PENG) block.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: PENG Block With RopivacaineActive comparator 1 intervention
Group B: PENG Block With Ropivacaine Plus DexmedetomidineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to First Rescue Analgesia
Time (in hours) from the end of the PENG block (completion of local anesthetic injection) to the first administration of rescue analgesia (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS). Data will be collected from anesthesia records and postoperative medication charts.
Time frame
Within 48 hours after the end of surgerySecondary outcomes
1
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame
4 hours after surgery2
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame
8 hours after surgery3
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame
12 hours after surgery4
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame
24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov