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.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl

Intervention / Treatment
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* Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The purpose of this study is to determine the least sufficient dose of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg required for day-case lower abdominal and urologic surgeries , fewer adverse effects, faster recovery time, and shorter stay in post anesthesia care unit (PACU) in the geriatric patient population, as a previous study has investigated hyperbaric prilocaine (30 mg) when combined with fentanyl (20 µg) for a day-case perianal surgery, achieving a spinal anaesthesia with a mean sensory level of T9
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ● Group P1 (N 15)<br>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). | Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany<br>* Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows: Group P1 (N 15): 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). Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).<br>* Other names: Pilocaine 2%(2.5 ml) and 25 ug fentany;|
| Active Comparator: ● Group P2 (N 15)<br>Patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). | Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany<br>* Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows: Group P1 (N 15): 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). Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).<br>* Other names: Pilocaine 2%(2.5 ml) and 25 ug fentany;|
| Active Comparator: ● Group P3 (N 15)<br>patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml) | Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany<br>* Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows: Group P1 (N 15): 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). Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).<br>* Other names: Pilocaine 2%(2.5 ml) and 25 ug fentany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of motor Block in hours | The primary outcome measure will be duration of motor Block in minutes, defined as the duration between intrathecal drug injection and time to unassisted ambulation or Bromage's score = 0 (no motor block). | Through Study Completion,an average of 1day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of sensory block in minutes | Onset of sensory block, defined as the duration between intrathecal drug injection and complete absence of skin sensation to the pinprick test at T10 dermatome level in minutes. | Through Study Completion,an average of 1day | 
| Onset of motor block in minutes | Onset of motor block, defined as the duration between intrathecal drug injection and reaching a Bromage's score ≥ 2 in minutes. | Through Study Completion,an average of 1day | 
| Highest dermatomal level of sensory block. | Highest dermatomal level of sensory block. | Through Study Completion,an average of 1day | 
| Time to reach to highest sensory block in minutes. | Time to reach to highest sensory block in minutes. | Through study completion,an average of 1day | 
| Motor block at the time of reaching highest sensory block. | Motor block at the time of reaching highest sensory block. | through study completion,an average of 1day | 
| Full regression of sensory block | Full regression of sensory block, defined as the duration between intrathecal drug injection and regression to the S2 dermatome in minutes. | Through Study Completion,an average of 1day | 
| Duration of PACU stay | Duration of Post Anesthesia Care Unit stay in minutes. | Through Study Completion,an average of 1day | 
| The incidence of adverse effects | The incidence of adverse effects like hypotension, bradycardia, apnea, nausea, shivering, pruritus, block failure and pain during the operation. Failure to achieve a block level of T10 or additional analgesia request will be considered as block failure. Hypotension will be defined as a systolic blood pressure of < 90 mmHg or a decrease in mean arterial pressure of more than 20% from baseline preoperative value and bradycardia will be defined as heart rate < 50 beat/min. | Through Study Completion,an average of 1day |