A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.

Cairo University (CU)

Status and phase

Completed

Phase 3

Conditions

Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl

Treatments

Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany

Study type

Interventional

Funder types

Other

Identifiers

NCT05726968

MD-248-2022

Details and patient eligibility

About

To compare the effects of using different doses of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg in patients scheduled for a day-case lower abdominal and urologic surgery in the geriatric patient population.

Full description

To evaluate the safety and effectiveness of spinal anaesthesia with hyperbaric Prilocaine 2% in a reduced dose (30mg) in combination with Fentanyl (25µg) in day-case lower abdominal and urologic surgeries in the geriatric population.
To compare between three different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.
To estimate the duration of stay in PACU and hospital stay with different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.

Enrollment

45 patients

Sex

All

Ages

65 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age (65 - 80)
ASA I - III
Both genders.
Height (1.60-1.90) m.
BMI (18.5-40) kg m-2
Scheduled for elective day-case lower abdominal or urologic procedures < 90 minutes in duration under spinal anesthesia.
Type of surgery: Inguinal, femoral and incisional herniorrhaphies, bilateral varicocelectomies, hydrocelectomy, lymph node biopsies and mass excision biopsies, TURP surgery, Cystoscopies, ureteroscopy, bladder stone extraction, DJ insertion.

Exclusion criteria

Patients requiring general anesthesia.
Operations requiring sensory block above T10.
Known or suspected coagulopathy (international normalised ratio > 1.4), thrombocytopenia (platelet count < 100,000).
Known peripheral neuropathy, neurological deficits or skeletal deformities.
Known allergy to prilocaine.
Infection at site of injection.
Patients' refusal to sign informed consent.
Patients 'not meet inclusion criteria.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 3 patient groups

● Group P1 (N 15)

Active Comparator group

Description:

Patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).

Treatment:

Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany

● Group P2 (N 15)

Active Comparator group

Description:

Patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).

Treatment:

Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany

● Group P3 (N 15)

Active Comparator group

Description:

patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml)