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NCT Number: NCT01921231

Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vic Hospital Consortium

Vic, Catalonia, 08500, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dr. Pere Roura-Poch

Other

Registry information

Official study title

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

Acronym: BUPIPRILO-07

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 13, 2013
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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