NCT07262398

Unilateral Intrathecal Bupivacaine Versus Prilocaine on Postoperative Spontaneous Voiding

Effect Of Unilateral Intra-thecal Prilocaine-Fentanyl Versus Bupivacaine-Fentanyl On Post-Operative Spontaneous Voiding Within The Context Of Ambulatory Anesthesia. A Prospective Randomized Double-Blind Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Theodor Bilharz Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Background: In the context of day-case surgery, the optimal spinal anesthetic should give immediate and effective anesthesia for an appropriate period, followed by rapid regression of sensory and motor blocking, rapid bladder voiding, and little residual effects to allow for early ambulation and discharge. Although bupivacaine is safe and has a low rate of transient neurological symptoms (TNS), the prolonged sensory and motor block is a drawback for use in day-case spinal anesthesia. Similar to lidocaine, prilocaine is a local anesthetic with similar potency and duration of action and has been reported to have a lower incidence of TNS. Objective: To determine which local anesthetic, Prilocaine with added fentanyl versus bupivacaine with added fentanyl, is better in the setting of fast-track anesthesia in patients undergoing unilateral inguinal hernia. Material and methods: 70 Patients who were between 18-60 years old male patients, ASA grade I-II, BMI \< 35, undergoing elective unilateral inguinal hernia, standard surgical technique (open anterior prosthetic inguinal hernioplasty) inguinal hernia diagnosis is confirmed by ultrasonography, free medical history of micturition disorder, procedure lasting less than 90 minutes, having provided written informed consent signed by the patient or guardian were included. Those patients were divided into two groups. Group Pr (Prilocaine 40mg + fentanyl 25μ) and group Bu (Bupivacaine 7.5mg + fentanyl 25mcg)

Conditions

• Fast Track Surgery

Interventions

Type	Name	Description
DRUG	Prilocaine	Prilocaine 40mg (2ml) + fentanyl 25mcg in unilateral spinal anesthesia
DRUG	Bupivacain	Bupivacaine 7.5mg (1.5ml) + fentanyl 25mcg in unilateral spinal anesthesia

Timeline

• Start date: 2024-08-03
• Primary completion: 2024-12-30
• Completion: 2025-01-15
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

1 site across 1 country: Egypt