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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07262398
Enrollment
70
Registered
2025-12-03
Start date
2024-08-03
Completion date
2025-01-15
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fast Track Surgery

Brief 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)

Interventions

Prilocaine 40mg (2ml) + fentanyl 25mcg in unilateral spinal anesthesia

DRUGBupivacain

Bupivacaine 7.5mg (1.5ml) + fentanyl 25mcg in unilateral spinal anesthesia

Sponsors

Theodor Bilharz Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

To compare unilateral intrathecal prilocaine versus bupivacaine with added fentanyl in both groups in inguinal hernia repair in the setting of fast-track anesthesia.

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. ASA I-II. 2. BMI \< 35 kg/m2. 3. Absence of micturition disorder. 4. Patients scheduled for elective unilateral inguinal hernia with standard surgical technique (open anterior prosthetic inguinal hernioplasty) with previous ultrasonography confirmation of the diagnosis.

Exclusion criteria

1. Allergic to any drug being used in the study. 2. ASA III-IV. 3. Suffering from bulky inguinal/inguino-scrotal hernias. 4. Patients with infection at the injection site. 5. Non-cooperative patients. 6. Patients having sensory or motor deficit in lower extremities or history of micturition disorder, abnormal coagulation profile, history of alcohol or substance abuse. 7. contraindications or failure of spinal anesthesia and surgery lasting more than 90 minutes.

Design outcomes

Primary

MeasureTime frameDescription
postoperative voidingfirst 2 hours postoperativelytime for the first spontaneous micturition

Secondary

MeasureTime frameDescription
peak level of spinal anesthesia15 minutespeak level of spinal anesthesia will be assessed by pinprick after 15 minutes from spinal anesthesia administration to determine the highest dermatome blocked.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026