An interventional study of ropivacaine in Postoperative Delirium (POD) and Peripheral Arterial Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
This randomized controlled trial will evaluate whether preoperative ultrasound-guided stellate ganglion block reduces the incidence of postoperative delirium in adults aged 60 years or older undergoing elective peripheral endovascular interventions. Participants will be randomly allocated in a 1:1 ratio to receive either a right-sided ultrasound-guided stellate ganglion block at the C6 level with 5 mL of 0.375% ropivacaine or a control group. Postoperative delirium will be assessed twice daily during the first 3 postoperative days using the 3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium (3D-CAM).
Postoperative delirium is a frequent complication among older adults undergoing surgery and vascular interventions. This study will investigate whether preoperative ultrasound-guided stellate ganglion block can reduce postoperative delirium through modulation of sympathetic activity and potentially inflammatory responses.
Eligible participants aged 60 years or older undergoing elective peripheral endovascular interventions will be randomly allocated in a 1:1 ratio to an active stellate ganglion block group or control group. The active intervention will consist of a right-sided ultrasound-guided stellate ganglion block performed at the C6 level approximately 30 minutes before surgery, using a 22-gauge needle and 5 mL of 0.375% ropivacaine. The control group will receive standard perioperative care and regional anesthesia according to the study protocol, but no stellate ganglion block or sham procedure will be performed
All participants will receive standardized anesthesia consisting of ultrasound-guided combined femoral and sciatic nerve blocks with bupivacaine, supplemented by dexmedetomidine sedation.
The primary outcome will be cumulative incidence of postoperative delirium from postoperative day 1 through postoperative day 3, assessed twice daily using the 3D-CAM. Secondary outcomes will include delirium severity, delirium duration, postoperative pain, opioid consumption, and safety/adverse events.
Exclusion Criteria:
Participants will receive a right-sided ultrasound-guided stellate ganglion block at the C6 level approximately 30 minutes before surgery. Under sterile conditions and real-time ultrasound guidance, a 22-gauge needle will be advanced to the prevertebral fascia. After negative aspiration, 5 mL of 0.375% ropivacaine will be injected. Successful sympathetic blockade will be assessed by development of Horner's syndrome and/or a relative increase in ipsilateral skin temperature of ≥1.5°C within 15 minutes after injection
Drug: ropivacaine
the participants will receive standard perioperative care and regional anesthesia according to the study protocol, but no stellate ganglion block or sham procedure will be performed
5 mL of 0.375% ropivacaine administered during ultrasound-guided right stellate ganglion block at the C6 level approximately 30 minutes before surgery.
Cumulative incidence of postoperative delirium
.Postoperative delirium will be assessed twice daily during the first 3 postoperative days using the 3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium (3D-CAM). A participant will be considered to have developed postoperative delirium if at least one postoperative delirium assessment is positive during the first 3 postoperative days.
Time frame: postoperative 24 hours , 48 hours , 72 hours.
Delirium severity
the severity of delirium will be graded using Memorial Delirium Assessment Scale (MDAS)
Time frame: postoperative 24 hours , 48 hours , 72 hours , among participants diagnosed with postoperative delirium
Duration of postoperative delirium
Number of postoperative days with a positive 3D-CAM assessment
Time frame: postoperative 24 hours , 48 hours , 72 hours.
Postoperative pain intensity
Postoperative pain intensity will be assessed by Numerical Rating Scale (NRS)
Time frame: Immediate postoperative period 2 hours 6 hours 12 hours 24 hours
Total postoperative opioid consumption
by Morphine milligram equivalents (MME)
Time frame: postoperative 24 hours , 48 hours , 72 hours.
Safety and adverse events
Time frame: postoperative 24 hours , 48 hours , 72 hours.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Assiut University