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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Hyperbaric Prilocaine 1%
Hyperbaric bupivacaine 0.5%
Sponsored by
Dr. Pere Roura-Poch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthroscopy (for Diagnostic or Therapy)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vic Hospital Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hyperbaric prilocaine 1%

Hyperbaric Bupivacaine 0.5%

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Level of motor blocking
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)
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
The sensory block level was determined pricking dermatomes with a pin from down to up.
Transient neurological symptoms
Researchers surveyed if appears pain originated in gluteal region and radiating to both lower extremities following patients by phone.

Full Information

First Posted
August 1, 2013
Last Updated
August 9, 2013
Sponsor
Dr. Pere Roura-Poch
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1. Study Identification

Unique Protocol Identification Number
NCT01921231
Brief Title
Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine
Acronym
BUPIPRILO-07
Official Title
Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine in Knee Arthroscopy and Inguinal Hernia Repair in Ambulatory Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Pere Roura-Poch

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthroscopy (for Diagnostic or Therapy), Inguinal Hernia Repair (Not Urgent)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric prilocaine 1%
Arm Type
Experimental
Arm 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.
Arm Title
Hyperbaric Bupivacaine 0.5%
Arm Type
Active Comparator
Arm Description
Solution for injection. Intradural use. Charge a syringe with 1 mL of Bupivacaine (0.5%) and administer it in a minute.
Intervention Type
Drug
Intervention Name(s)
Hyperbaric Prilocaine 1%
Intervention Description
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
Intervention Name(s)
Hyperbaric bupivacaine 0.5%
Intervention Description
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 Measure Information:
Title
Length of stay in post-operative care unit (in minutes)
Description
Time in minutes from closing the surgical incision until to having criteria for discharge to home.
Time Frame
Participants will be followed an average of 6 hours from surgical incision closure to accomplish discharge criteria to go home
Secondary Outcome Measure Information:
Title
Level of motor blocking
Description
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).
Time Frame
At surgical incision and at 60 minutes after anesthesia
Title
Fast-track (by-pass recovery area)
Description
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.
Time Frame
Participants will be assessed when surgical incision is closed with surgical staples
Title
Peak sensory block level
Description
The sensory block level was determined pricking dermatomes with a pin from down to up.
Time Frame
One minute before surgical incision
Title
Transient neurological symptoms
Description
Researchers surveyed if appears pain originated in gluteal region and radiating to both lower extremities following patients by phone.
Time Frame
At hospital discharge (an average of 8 hours after admission), and at home at 24, 48 and 72 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordi Serrat-Puyol, MD
Organizational Affiliation
Vic Hospital Consortium
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pere Roura-Poch, MD, MPH
Organizational Affiliation
Vic Hospital Consortium
Official's Role
Study Chair
Facility Information:
Facility Name
Vic Hospital Consortium
City
Vic
State/Province
Catalonia
ZIP/Postal Code
08500
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine

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