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Completed

NCT Number: NCT07262398

Unilateral Intrathecal Bupivacaine Versus Prilocaine on Postoperative Spontaneous Voiding

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)

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Theodor Bilharz Research institute

Giza, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Prilocaine

Drug

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

Bupivacain

Drug

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

Primary outcomes

  1. postoperative voiding

    Time frame: first 2 hours postoperatively

    time for the first spontaneous micturition

Secondary outcomes

  1. peak level of spinal anesthesia

    Time frame: 15 minutes

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

Sponsors and collaborators

Lead sponsor

Theodor Bilharz Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.