Day-Case, Hyperbaric, Perianal Surgery, Prilocaine, Spinal Anesthesia
Conditions
Brief summary
The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery.
Detailed description
Day-case spinal anesthesia with short-acting local anesthetics such as lidocaine and chloroprocaine can provide short times to discharge. However, the association of lidocaine with transient neurologic symptoms (TNS) and chloroprocaine with neurologic injury has limited the use of these agents in spinal anesthesia. Hyperbaric bupivacaine has been used for spinal anesthesia for decades owing to the low incidence of TNS. Prilocaine is also an amide local anesthetic that has an intermediate duration of action. It is available in the hyperbaric form that can be used for spinal anesthesia in day-case surgeries. Hyperbaric prilocaine provides faster spinal block onset and earlier patient recovery in ambulatory surgery compared to plain prilocaine.
Interventions
Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.
Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 65 years. * Both sexes. * American Society of Anesthesiology (ASA) physical status I-II. * Scheduled for perianal surgery under spinal anesthesia.
Exclusion criteria
* Allergy to the studied drugs. * Patients with contraindications to spinal anesthesia. * Patients with advanced cardiac, renal, or hepatic diseases. * Previous voiding difficulty. * Patients taking anticholinergic medications. * Time of surgery exceeds 75 min.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time till home readiness | 24 hours postoperatively | The time-to-home readiness will be assessed as the time from the end of surgery until the patients reached a post-anesthesia discharge score (PADS) ≥9 and were able to void spontaneously or receive a urinary catheter, and the sensory block resolved to the S3 dermatome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of onset of motor block | Intraoperatively | The time of onset of the motor block will be assessed from intrathecal injection of local anesthetic until a grade 3 Bromage score is achieved |
| Time to spontaneous voiding | 24 hours postoperatively | Time to spontaneous voiding will be recorded. |
| Time to the 1st rescue analgesia | 24 hours postoperatively | Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of pethidine administrated |
| Time to block regression | 6 hours postoperatively | The time to block regression will be from intrathecal injection until sensation is regained at the S1 dermatome. |
| Heart rate | Every 10 min till the end of surgery (up to 1 hour) | Heart rate will be recorded throughout the operation: every 5 minutes for the first 15 minutes and every 10 minutes until the end of the surgery. |
| Mean arterial pressure | Every 10 min till the end of surgery (up to 1 hour) | Mean arterial pressure will be recorded throughout the operation: every 5 minutes for the first 15 minutes and every 10 minutes until the end of the surgery. |
| Incidence of adverse events | 24 hours postoperatively | Incidence of adverse events such as postoperative nausea and vomiting (PONV), voiding difficulty, or any other complication. |
| Total ketorolac consumption | 24 hours postoperatively | Total ketorolac consumption will be recorded. If the numerical rating scale (NRS) becomes ≥3, 30 mg ketorolac IM will be given when needed (maximum every six hours). |
Countries
Egypt
Outcome results
None listed