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.

Phase 3

Completed

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

• Registration Number: NCT05726968
• Lead Sponsor: Cairo University

Brief Summary

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

* 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 Timeline

• Study Start: 2022-11-14
• Study First Submitted: 2022-11-16
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-04
• Study First Posted: 2023-02-14
• Primary Completion: 2023-06-16
• Study Completion: 2023-12-05
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
● Group P1 (N 15)	Pilocaine 2% (1.5 ml) and 25 ug fentany	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)	Pilocaine 2% (1.5 ml) and 25 ug fentany	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)	Pilocaine 2% (1.5 ml) and 25 ug fentany	patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml)

Primary Outcome Measures

Name	Time	Method
Duration of motor Block in hours	Through Study Completion,an average of 1day	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).

Secondary Outcome Measures

Name	Time	Method
Onset of motor block in minutes	Through Study Completion,an average of 1day	Onset of motor block, defined as the duration between intrathecal drug injection and reaching a Bromage's score ≥ 2 in minutes.
Highest dermatomal level of sensory block.	Through Study Completion,an average of 1day	Highest dermatomal level of sensory block.
Onset of sensory block in minutes	Through Study Completion,an average of 1day	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.
Motor block at the time of reaching highest sensory block.	through study completion,an average of 1day	Motor block at the time of reaching highest sensory block.
Full regression of sensory block	Through Study Completion,an average of 1day	Full regression of sensory block, defined as the duration between intrathecal drug injection and regression to the S2 dermatome in minutes.
Duration of PACU stay	Through Study Completion,an average of 1day	Duration of Post Anesthesia Care Unit stay in minutes.
Time to reach to highest sensory block in minutes.	Through study completion,an average of 1day	Time to reach to highest sensory block in minutes.
The incidence of adverse effects	Through Study Completion,an average of 1day	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.

Trial Locations

Locations (1)

Ahmed Abdalla Mohamed; 🇪🇬 Cairo, Egypt