Trial | NCT01921231  Report issue

Title

Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine
Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine in Knee Arthroscopy and Inguinal Hernia Repair in Ambulatory Surgery

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    119
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.
Study Started
May 31
2007
Primary Completion
May 31
2007
Study Completion
Dec 31
2007
Last Update
Aug 13
2013
Estimate

Drug Hyperbaric Prilocaine 1%

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.

Drug Hyperbaric bupivacaine 0.5%

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.

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.

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.

Criteria 

Inclusion Criteria:

Patients with a scheduled knee arthroscopy
Patients with a scheduled inguinal hernioplasty

Exclusion Criteria:

Patient refusal to regional anesthesia
American Society of Anesthesiologists score risk equal or greater than 4
Body mass index greater than 32
Coagulopathy
Cutaneous infection at injection site
No Results Posted