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.

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.

Study Overview

• Status: Completed
• Conditions: Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl
• Intervention / Treatment: Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ● 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).	Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany; 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).; Other Names: Pilocaine 2%(2 ml) and 25 ug fentany; Pilocaine 2%(2.5 ml) and 25 ug fentany
Active Comparator: ● 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).	Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany; 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).; Other Names: Pilocaine 2%(2 ml) and 25 ug fentany; Pilocaine 2%(2.5 ml) and 25 ug fentany
Active Comparator: ● 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)	Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany; 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).; Other Names: Pilocaine 2%(2 ml) and 25 ug fentany; Pilocaine 2%(2.5 ml) and 25 ug fentany

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Norhan Abdel Aleem Ali; Hagar Hassanein Refaee; Ahmed Abdullah Fathi Mohamed Almadawi

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: February 4, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 13, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MD-248-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Till Study Ending

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No