Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine

Phase 4

Completed

• Conditions: Knee Arthroscopy (for Diagnostic or Therapy); Inguinal Hernia Repair (Not Urgent)
• Interventions: Drug: Hyperbaric bupivacaine 0.5%; Drug: Hyperbaric Prilocaine 1%

• Registration Number: NCT01921231
• Lead Sponsor: Dr. Pere Roura-Poch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2007-05
• Study Completion: 2007-12
• Status Verified: 2013-08
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-09
• Last Update Submitted: 2013-08-09
• Study First Posted: 2013-08-13
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperbaric Bupivacaine 0.5%	Hyperbaric bupivacaine 0.5%	Solution for injection. Intradural use. Charge a syringe with 1 mL of Bupivacaine (0.5%) and administer it in a minute.
Hyperbaric prilocaine 1%	Hyperbaric Prilocaine 1%	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.

Primary Outcome Measures

Name	Time	Method
Length of stay in post-operative care unit (in minutes)	Participants will be followed an average of 6 hours from surgical incision closure to accomplish discharge criteria to go home	Time in minutes from closing the surgical incision until to having criteria for discharge to home.

Secondary Outcome Measures

Name	Time	Method
Level of motor blocking	At surgical incision and at 60 minutes after anesthesia	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).
Fast-track (by-pass recovery area)	Participants will be assessed when surgical incision is closed with surgical staples	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.
Peak sensory block level	One minute before surgical incision	The sensory block level was determined pricking dermatomes with a pin from down to up.
Transient neurological symptoms	At hospital discharge (an average of 8 hours after admission), and at home at 24, 48 and 72 hours after surgery	Researchers surveyed if appears pain originated in gluteal region and radiating to both lower extremities following patients by phone.

Trial Locations

Locations (1)

Vic Hospital Consortium; 🇪🇸 Vic, Catalonia, Spain