Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine

Inguinal Hernia Repair (Not Urgent) Clinical Trial

— BUPIPRILO-07  

Official title:

Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine in Knee Arthroscopy and Inguinal Hernia Repair in Ambulatory Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921231
• Other study ID #: 2006-006930-17
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2013
• Last updated: August 9, 2013
• Start date: May 2007
• Est. completion date: December 2007

Study information

• Verified date: August 2013
• Source: Consorci Hospitalari de Vic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Departament de Salut de la Generalitat de Catalunya
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Vic Hospital Consortium	Vic	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Pere Roura-Poch

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).	At surgical incision and at 60 minutes after anesthesia	No
Secondary	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.	Participants will be assessed when surgical incision is closed with surgical staples	No
Secondary	Peak sensory block level	The sensory block level was determined pricking dermatomes with a pin from down to up.	One minute before surgical incision	No
Secondary	Transient neurological symptoms	Researchers surveyed if appears pain originated in gluteal region and radiating to both lower extremities following patients by phone.	At hospital discharge (an average of 8 hours after admission), and at home at 24, 48 and 72 hours after surgery	No