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Completed

NCT Number: NCT05726968

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.

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Key information

Conditions

Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilocaine 2% (1.5 ml) and 25 ug fentany

Drug

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

Primary outcomes

  1. Duration of motor Block in hours

    Time frame: 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 outcomes

  1. Onset of sensory block in minutes

    Time frame: 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.

  2. Onset of motor block in minutes

    Time frame: 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.

  3. Highest dermatomal level of sensory block.

    Time frame: Through Study Completion,an average of 1day

    Highest dermatomal level of sensory block.

  4. Time to reach to highest sensory block in minutes.

    Time frame: Through study completion,an average of 1day

    Time to reach to highest sensory block in minutes.

  5. Motor block at the time of reaching highest sensory block.

    Time frame: through study completion,an average of 1day

    Motor block at the time of reaching highest sensory block.

  6. Full regression of sensory block

    Time frame: 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.

  7. Duration of PACU stay

    Time frame: Through Study Completion,an average of 1day

    Duration of Post Anesthesia Care Unit stay in minutes.

  8. The incidence of adverse effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Ahmed Abdullah Fathi Mohamed Almadawi
  • Hagar Hassanein Refaee
  • Norhan Abdel Aleem Ali

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2023
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.