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

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ClinicalTrials.gov Identifier: NCT01921231
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Pere Roura-Poch, Consorci Hospitalari de Vic

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.

Condition or disease Intervention/treatment Phase
Knee Arthroscopy (for Diagnostic or Therapy) Inguinal Hernia Repair (Not Urgent) Drug: Hyperbaric Prilocaine 1% Drug: Hyperbaric bupivacaine 0.5% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine in Knee Arthroscopy and Inguinal Hernia Repair in Ambulatory Surgery
Study Start Date : May 2007
Actual Primary Completion Date : May 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Length of stay in post-operative care unit (in minutes) [ Time Frame: 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 :
  1. Level of motor blocking [ Time Frame: 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).

  2. Fast-track (by-pass recovery area) [ Time Frame: 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.

  3. Peak sensory block level [ Time Frame: One minute before surgical incision ]
    The sensory block level was determined pricking dermatomes with a pin from down to up.

  4. Transient neurological symptoms [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921231


Locations
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Spain
Vic Hospital Consortium
Vic, Catalonia, Spain, 08500
Sponsors and Collaborators
Dr. Pere Roura-Poch
Investigators
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Study Director: Jordi Serrat-Puyol, MD Vic Hospital Consortium
Study Chair: Pere Roura-Poch, MD, MPH Vic Hospital Consortium

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Responsible Party: Dr. Pere Roura-Poch, Head of Clinical epidemiology department, Consorci Hospitalari de Vic
ClinicalTrials.gov Identifier: NCT01921231     History of Changes
Other Study ID Numbers: 2006-006930-17
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics
Bupivacaine
Prilocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents