Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Hyperbaric prilocaine
- Conditions
- Spinal Anesthesia
- Sponsor
- Tanta University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Time till home readiness
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University
Eligibility Criteria
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.
Arms & Interventions
Hyperbaric prilocaine group
Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.
Intervention: Hyperbaric prilocaine
Hyperbaric bupivacaine group
Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.
Intervention: Hyperbaric bupivacaine
Outcomes
Primary Outcomes
Time till home readiness
Time Frame: 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 Outcomes
- Time to block regression(6 hours postoperatively)
- Time of onset of motor block(Intraoperatively)
- Time to spontaneous voiding(24 hours postoperatively)
- Time to the 1st rescue analgesia(24 hours postoperatively)
- Total ketorolac consumption(24 hours postoperatively)
- Heart rate(Every 10 min till the end of surgery (up to 1 hour))
- Mean arterial pressure(Every 10 min till the end of surgery (up to 1 hour))
- Incidence of adverse events(24 hours postoperatively)