drugset / Trial / NCT07262398

Unilateral Intrathecal Bupivacaine Versus Prilocaine on Postoperative Spontaneous Voiding

NCT07262398

Phase 4 Completed 70 enrolled Theodor Bilharz Research Institute
RandomizedCrossoverQuadruple-blindDiagnostic

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)

Timeline

Start
2024-08-03
Primary completion
2024-12-30
Completion
2025-01-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 7.5 mg Intrathecal
Comparator prilocaine Small molecule 40 mg Intrathecal
Comparator Fentanyl Other / unclassified 25 ug Intrathecal

Indications

No indication recorded.