Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine

NCT01921231 | Completed Phase 4 DMC

• 1 other identifier: 2006-006930-17
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Level of motor blocking

  At surgical incision and at 60 minutes after anesthesia

• Fast-track (by-pass recovery area)

  Participants will be assessed when surgical incision is closed with surgical staples

• Peak sensory block level

  One minute before surgical incision

• Transient neurological symptoms

  At hospital discharge (an average of 8 hours after admission), and at home at 24, 48 and 72 hours after surgery

Study Arms (2)

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.

Drug: Hyperbaric Prilocaine 1%

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.

Drug: Hyperbaric bupivacaine 0.5%

Interventions

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.

Hyperbaric prilocaine 1%

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.

Hyperbaric Bupivacaine 0.5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Pere Roura-Poch: lead

Study Sites (1)

Vic Hospital Consortium

Vic, Catalonia, 08500, Spain

Location

Study Officials

• Jordi Serrat-Puyol, MD

  Vic Hospital Consortium

  STUDY DIRECTOR

• Pere Roura-Poch, MD, MPH

  Vic Hospital Consortium

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinical epidemiology department

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 13, 2013
• Study Start: May 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

ES (1)