Unilateral Intrathecal Bupivacaine Versus Prilocaine on Postoperative Spontaneous Voiding

NCT07262398 | Completed Phase 4 DMC

• 1 other identifier: PT (862)
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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)

Conditions

Fast Track Surgery

Outcome Measures

Primary Outcomes (1)

• postoperative voiding

  time for the first spontaneous micturition

  first 2 hours postoperatively

Secondary Outcomes (1)

• peak level of spinal anesthesia

  15 minutes

Study Arms (2)

prilocaine

ACTIVE COMPARATOR

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

Drug: Prilocaine

Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacain

Interventions

Prilocaine DRUG

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

prilocaine

Bupivacain DRUG

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

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: males with no past history of urinary symptoms
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research institute

Giza, Egypt

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 33456853 BACKGROUND

MeSH Terms

Interventions

Prilocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of anesthesia

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

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 3, 2025
• Study Start: August 3, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 15, 2025
• Last Updated: December 3, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1/12/2025 till 30/12/2026
• Access Criteria: researches

Locations

EG (1)