Unilateral Intrathecal Bupivacaine Versus Prilocaine on Postoperative Spontaneous Voiding

Theodor Bilharz Research Institute

Status and phase: Completed; Phase 4

Conditions: Fast Track Surgery

Treatments: Drug: Prilocaine; Drug: Bupivacain

Study type: Interventional

Funder types: Other

Identifiers

NCT07262398

PT (862)

Details and patient eligibility

About

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)

Enrollment: 70 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

prilocaine

Active Comparator group

Description:

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

Treatment:

Drug: Prilocaine

Bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacain