An interventional study of Hyperbaric prilocaine and Hyperbaric bupivacaine in Spinal Anesthesia, Hyperbaric and Prilocaine, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery.
Day-case spinal anesthesia with short-acting local anesthetics such as lidocaine and chloroprocaine can provide short times to discharge. However, the association of lidocaine with transient neurologic symptoms (TNS) and chloroprocaine with neurologic injury has limited the use of these agents in spinal anesthesia.
Hyperbaric bupivacaine has been used for spinal anesthesia for decades owing to the low incidence of TNS.
Prilocaine is also an amide local anesthetic that has an intermediate duration of action. It is available in the hyperbaric form that can be used for spinal anesthesia in day-case surgeries.
Hyperbaric prilocaine provides faster spinal block onset and earlier patient recovery in ambulatory surgery compared to plain prilocaine.
Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.
Drug: Hyperbaric prilocaine
Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.
Drug: Hyperbaric bupivacaine
Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.
Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.
Time till home readiness
The time-to-home readiness will be assessed as the time from the end of surgery until the patients reached a post-anesthesia discharge score (PADS) ≥9 and were able to void spontaneously or receive a urinary catheter, and the sensory block resolved to the S3 dermatome.
Time frame: 24 hours postoperatively
Time to block regression
The time to block regression will be from intrathecal injection until sensation is regained at the S1 dermatome.
Time frame: 6 hours postoperatively
Time of onset of motor block
The time of onset of the motor block will be assessed from intrathecal injection of local anesthetic until a grade 3 Bromage score is achieved
Time frame: Intraoperatively
Time to spontaneous voiding
Time to spontaneous voiding will be recorded.
Time frame: 24 hours postoperatively
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of pethidine administrated
Time frame: 24 hours postoperatively
Total ketorolac consumption
Total ketorolac consumption will be recorded. If the numerical rating scale (NRS) becomes ≥3, 30 mg ketorolac IM will be given when needed (maximum every six hours).
Time frame: 24 hours postoperatively
Heart rate
Heart rate will be recorded throughout the operation: every 5 minutes for the first 15 minutes and every 10 minutes until the end of the surgery.
Time frame: Every 10 min till the end of surgery (up to 1 hour)
Mean arterial pressure
Mean arterial pressure will be recorded throughout the operation: every 5 minutes for the first 15 minutes and every 10 minutes until the end of the surgery.
Time frame: Every 10 min till the end of surgery (up to 1 hour)
Incidence of adverse events
Incidence of adverse events such as postoperative nausea and vomiting (PONV), voiding difficulty, or any other complication.
Time frame: 24 hours postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Tanta University