Modified Saddle Block vs Spinal Anesthesia for TURP

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age40-90
SponsorPakistan Institute of Medical Sciences

About this trial

After obtaining informed consent, eligible patients will be enrolled in the study. Standard monitoring will be applied in the operating room and baseline blood pressure and heart rate will be recorded. Participants will be randomly assigned to receive either spinal anesthesia or a modified saddle block using hyperbaric bupivacaine administered in the lower back. The position of the patient after injection will differ according to the assigned anesthetic technique. The level of numbness produced by the anesthesia will be assessed, and patients with inadequate anesthesia will be excluded. Blood pressure and heart rate will be monitored regularly during surgery. Any significant decrease in blood pressure will be treated with intravenous phenylephrine. Any need to change to general anesthesia during the procedure will also be recorded.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 40- 90 years

Elective TURP surgery under Neuraxial Anesthesia

ASA class I and II

Disqualifiers

Contraindication to Neuraxial anesthesia

Allergic to study medications

Lack of consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saddle block

    Drug

    Patients will receive with 15 mg of hyperbaric bupivacaine at L3 L4 level using 25 G spinal needle and will be made to sit for 5 minutes before lying down

  • Spinal Anesthesia (bupivacaine)

    Drug

    Patients will receive spinal anesthesia with 15mg of hyperbaric bupivacaine at L3 L4 level using 25G spinal needle and will be immediately made to lie down

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group SaddleActive comparator 1 intervention
Group B: Group Spinal anesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximum fall in Mean Arterial Pressure

Maximum decrease in mean arterial pressure (MAP) from the pre-induction baseline value recorded during the intraoperative period, measured using automated oscillometric non-invasive blood pressure monitoring. MAP will be recorded at predefined intraoperative intervals, and the greatest fall from baseline will be reported in mmHg.

Time frame
Peri-operative from From induction of anesthesia until completion of surgery

Secondary outcomes

1

Conversion rate to General Anesthesia

This will be the number of patients requiring conversion of either spinal or saddle anesthesia to general anesthesia intraoperatively due to block failure

Time frame
Peri-operative

Other outcomes

Sponsors and contacts

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