Unilateral Intrathecal Bupivacaine Versus Prilocaine on Postoperative Spontaneous Voiding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-03

Study Completion Date

2025-01-15

Brief Summary

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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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Detailed Description

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Conditions

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Fast Track Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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prilocaine

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

Group Type ACTIVE_COMPARATOR

Prilocaine

Intervention Type DRUG

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

Bupivacaine

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

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

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

Interventions

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Prilocaine

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

Intervention Type DRUG

Bupivacain

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No