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.
* 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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
45
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).
Ahmed Abdalla Mohamed
Cairo, Egypt
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).
Time frame: Through Study Completion,an average of 1day
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.
Time frame: 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.
Time frame: Through Study Completion,an average of 1day
Highest dermatomal level of sensory block.
Highest dermatomal level of sensory block.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: Through Study Completion,an average of 1day
Duration of PACU stay
Duration of Post Anesthesia Care Unit stay in minutes.
Time frame: 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.
Time frame: Through Study Completion,an average of 1day