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Selective spinal anesthesia is widely used for ambulatory surgery. Unilateral spinal anesthesia is a suitable option for ambulatory anesthesia as it is efficient and effective. Lidocaine has been the well-known choice for this procedure. However, it is associated to transient neurologic symptoms (TNS). Different anesthetic strategies for this procedure have been performed, for example, the use of small doses of long-acting agents and the use of additives such as opioids. The ideal local anesthetic should be lidocaine-like without risk of transient neurologic symptoms. We design and plan a randomised clinical trial to show if hyperbaric prilocaine 2% would be an alternative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric prilocaine 1% | Experimental | Solution for injection. Intradural use. In order to obtain Prilocaine 1% we charge a syringe with 2 mL Prilocaine 2%, and we add 1 mL Saline solution (0.9%) and 1 mL Glucose solution (33%). Administer 3 mL of syringe contains in two minutes. |
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| Hyperbaric Bupivacaine 0.5% | Active Comparator | Solution for injection. Intradural use. Charge a syringe with 1 mL of Bupivacaine (0.5%) and administer it in a minute. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Prilocaine 1% | Drug | Selective spinal anesthesia was performed on induction-block area and patient was transferred to the assigned operating room where another anesthesiologist (blinded for the arm) began to evaluate the blocking. Neither the nurse, surgeon nor the anesthesiologist involved in the patient evaluation knew the allocation group. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay in post-operative care unit (in minutes) | Time in minutes from closing the surgical incision until to having criteria for discharge to home. | Participants will be followed an average of 6 hours from surgical incision closure to accomplish discharge criteria to go home |
| Measure | Description | Time Frame |
|---|---|---|
| Level of motor blocking | Assessed by Bromage score who ranges from Complete block (unable to move feet or knees, score 1) to Able to perform partial knee bend (score 6 who means nil block). | At surgical incision and at 60 minutes after anesthesia |
| Fast-track (by-pass recovery area) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordi Serrat-Puyol, MD | Vic Hospital Consortium | Study Director |
| Pere Roura-Poch, MD, MPH | Vic Hospital Consortium | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vic Hospital Consortium | Vic | Catalonia | 08500 | Spain |
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| Hyperbaric bupivacaine 0.5% | Drug | Selective spinal anesthesia was performed on induction-block area and patient was transferred to the assigned operating room where another anesthesiologist (blinded for the arm) began to evaluate the blocking. Neither the nurse, surgeon nor the anesthesiologist involved in the patient evaluation knew the allocation group. |
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Number (and percentage) of patients in each arm that can be transferred directly from the operating room to postsurgical ward. A minimal score of 12 (on modified Aldrete's scoring system with no score <1 in any individual category) would be required for a patient to be fast-tracked. |
| Participants will be assessed when surgical incision is closed with surgical staples |
| Peak sensory block level | The sensory block level was determined pricking dermatomes with a pin from down to up. | One minute before surgical incision |
| Transient neurological symptoms | Researchers surveyed if appears pain originated in gluteal region and radiating to both lower extremities following patients by phone. | At hospital discharge (an average of 8 hours after admission), and at home at 24, 48 and 72 hours after surgery |