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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric prilocaine group | Experimental | Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine. |
|
| Hyperbaric bupivacaine group | Active Comparator | Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric prilocaine | Drug | Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Time to block regression | The time to block regression will be from intrathecal injection until sensation is regained at the S1 dermatome. | 6 hours postoperatively |
| Time of onset of motor block |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Hyperbaric bupivacaine | Drug | Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine. |
|
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
| Intraoperatively |
| Time to spontaneous voiding | Time to spontaneous voiding will be recorded. | 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 | 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). | 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. | 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. | 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. | 24 hours postoperatively |