Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine (BUPIPRILO-07)

Dr. Pere Roura-Poch

Status and phase: Completed; Phase 4

Conditions: Knee Arthroscopy (for Diagnostic or Therapy); Inguinal Hernia Repair (Not Urgent)

Treatments: Drug: Hyperbaric Prilocaine 1%; Drug: Hyperbaric bupivacaine 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT01921231

2006-006930-17

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

119 participants in 2 patient groups

Hyperbaric prilocaine 1%

Experimental group

Description:

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.

Treatment:

Drug: Hyperbaric Prilocaine 1%

Hyperbaric Bupivacaine 0.5%

Active Comparator group

Description:

Solution for injection. Intradural use. Charge a syringe with 1 mL of Bupivacaine (0.5%) and administer it in a minute.

Treatment:

Drug: Hyperbaric bupivacaine 0.5%