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

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)

Study Overview

• Status: Completed
• Conditions: Fast Track Surgery
• Intervention / Treatment: Drug: Prilocaine; Drug: Bupivacain

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Theodor Bilharz Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: prilocaine; Prilocaine 40mg (2ml) + fentanyl 25mcg in unilateral spinal anesthesia	Drug: Prilocaine; Prilocaine 40mg (2ml) + fentanyl 25mcg in unilateral spinal anesthesia
Active Comparator: Bupivacaine; Bupivacaine 7.5mg (1.5ml) + fentanyl 25mcg in unilateral spinal anesthesia	Drug: Bupivacain; Bupivacaine 7.5mg (1.5ml) + fentanyl 25mcg in unilateral spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative voiding	time for the first spontaneous micturition	first 2 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak level of spinal anesthesia	peak level of spinal anesthesia will be assessed by pinprick after 15 minutes from spinal anesthesia administration to determine the highest dermatome blocked.	15 minutes

Collaborators and Investigators

• Sponsor: Theodor Bilharz Research Institute

Publications and helpful links

General Publications

• Rattenberry W, Hertling A, Erskine R. Spinal anaesthesia for ambulatory surgery. BJA Educ. 2019 Oct;19(10):321-328. doi: 10.1016/j.bjae.2019.06.001. Epub 2019 Aug 13. No abstract available.
• Manish B. Kotwani, Kanchan Rupwate, Prashanth Shivananda, et al. Comparison between high dose hyperbaric Bupivacaine (12.5 mg) alone versus low dose hyperbaric Bupivacaine (7.5mg) with Fentanyl (25 μg) in spinal Anaesthesia for inguinal hernia surgery. Int J Clin Trials. 2016 Aug; 3(3):140-146.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine; Prilocaine
• Other Study ID Numbers: PT (862)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data will be provided upon request from the principal investigator
• IPD Sharing Time Frame: 1/12/2025 till 30/12/2026
• IPD Sharing Access Criteria: researches
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No