Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery

Tanta University90 enrolled

Overview

The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Spinal Anesthesia Hyperbaric Prilocaine Day-Case Perianal Surgery

Interventions

Hyperbaric prilocaineDRUG

Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.

Hyperbaric bupivacaineDRUG

Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

Outcomes

Primary Outcomes

Time till home readiness

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.

Time frame: 24 hours postoperatively

Secondary Outcomes

Time to block regression

The time to block regression will be from intrathecal injection until sensation is regained at the S1 dermatome.

Time frame: 6 hours postoperatively

Time of onset of motor block

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 frame: Intraoperatively

Time to spontaneous voiding

Time to spontaneous voiding will be recorded.

Time frame: 24 hours postoperatively

Time to the 1st rescue analgesia

Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of pethidine administrated

Time frame: 24 hours postoperatively

Total ketorolac consumption

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).

Time frame: 24 hours postoperatively

Heart rate

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.

Data from ClinicalTrials.gov

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