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Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine

NCT ID: NCT01921231

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Hyperbaric Prilocaine 1%

Intervention Type 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%

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

Group Type ACTIVE_COMPARATOR

Hyperbaric bupivacaine 0.5%

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Pere Roura-Poch

OTHER

Sponsor Role lead

Responsible Party

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Dr. Pere Roura-Poch

Head of Clinical epidemiology department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jordi Serrat-Puyol, MD

Role: STUDY_DIRECTOR

Vic Hospital Consortium

Pere Roura-Poch, MD, MPH

Role: STUDY_CHAIR

Vic Hospital Consortium

Locations

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Vic Hospital Consortium

Vic, Catalonia, Spain

Site Status

Countries

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Spain

Other Identifiers

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2006-006930-17

Identifier Type: -

Identifier Source: org_study_id