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This study aims to compare the intrathecal injection of hyperbaric prilocaine 2% versus hyperbaric bupivacaine 0.5% in cystoscopy procedures.
Cystoscopy is a short surgical procedure in the field of urology that is very frequently performed. Spinal anesthesia (SA) is the choice because it has an easy implementation technique, fast onset, and low complications compared to general anesthesia.
One of the spinal anesthetic regimens often used is 0.5% hyperbaric bupivacaine, which has a two-segment regression time of around 65 minutes and requires 164 minutes for complete regression to the sacral dermatomes. However, bupivacaine, when used for relatively short procedures, causes various disadvantages including prolonged effects.
Prilocaine is an alternative to bupivacaine in short surgical procedures, including cystoscopy. It has a profile similar to lidocaine but with less neurotoxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine Group | Active Comparator | Patients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml). |
|
| Prilocaine Group | Experimental | Patients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Patients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time | Recovery time defined as the time required until the patient is ready for discharge. | Till discharge (Up to 4 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of side effects | Incidence of side effects such as hypotension, bradycardia, nausea, vomiting, pruritus, and urinary retention were recorded. | 24 hours postoperatively |
| Noninvasive Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
- Patient's refusal.
History of allergy to local anesthetics (hyperbaric prilocaine or hyperbaric bupivacaine).
History of impaired gait before the study.
Contraindications to SA including :-
Uncontrolled hypertension systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg.
Uncontrolled Diabetes mellitus HbA1c ≥ 8.5%
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helwan University | Helwan | 11795 | 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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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D011318 | Prilocaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Prilocaine | Drug | Patients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml). |
|
Noninvasive Blood pressure was monitored every 3 min for the first 15 minutes.
| Till discharge from hospital (Up to 2 hours) |
| Heart rate | Heart rate was monitored every 3 min for the first 15 minutes. | Till discharge from hospital (Up to 2 hours) |
| Degree of patient satisfaction | Degree of patient satisfaction was assessed on a 4-point scale (1, excellent; 2, good; 3, fair; 4, poor). | 24 hours postoperatively |
| D000588 |
| Amines |