Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery

Tanta University

Status: Completed

Conditions: Spinal Anesthesia; Perianal Surgery; Prilocaine; Hyperbaric; Day-Case

Treatments: Drug: Hyperbaric prilocaine; Drug: Hyperbaric bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06600048

36264PR839/9/24

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Hyperbaric prilocaine group

Experimental group

Description:

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

Treatment:

Drug: Hyperbaric prilocaine

Hyperbaric bupivacaine group

Active Comparator group

Description:

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

Treatment:

Drug: Hyperbaric bupivacaine