Inguinal Hernia Repair (Not Urgent), Knee Arthroscopy (for Diagnostic or Therapy)
Conditions
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.
Interventions
DRUGHyperbaric 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.
DRUGHyperbaric 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.
Sponsors
Dr. Pere Roura-Poch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in post-operative care unit (in minutes) | 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
| Measure | Time frame | Description |
|---|---|---|
| Level of motor blocking | 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). |
| Fast-track (by-pass recovery area) | 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. |
| Peak sensory block level | One minute before surgical incision | The sensory block level was determined pricking dermatomes with a pin from down to up. |
| Transient neurological symptoms | 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. |
Countries
Spain
Outcome results
None listed