A Phase 4 interventional study of Saddle block and Spinal Anesthesia (bupivacaine) in TURP(Transurethral Resection of Prostate), Spinal Anesthesia and Saddle Block Anesthesia, sponsored by Pakistan Institute of Medical Sciences. Recruiting at 1 site in Pakistan. Open to male participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Pakistan Institute of Medical Sciences · Phase 4, Interventional, and Prevention
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.
After informed consent, patient fulfilling the inclusion criteria will be enrolled in the study. All patients will be brought into OR and standard ASA monitoring will be attached and baseline hemodynamics will be recorded. Patients will be randomly divided into two groups using computer generated random numbers. Group N patients will receive spinal anesthesia with 15mg of hyperbaric bupivacaine at L3 L4 level using 25G spinal needle while group S will receive saddle block with 15 mg of hyperbaric bupivacaine at L3 L4 level using 25 G spinal needle. Those receiving spinal anesthesia will be made to lie down immediately after intrathecal drug administration while those who received saddle block will be made to sit for five minutes and then will be made to lie down. Level of block will be assessed. Those having block less than T10 dermatome will be made excluded from the study. Intraoperatively hemodynamics will be monitored at 3 minutes interval. Any fall in blood pressure by more than 20% from baseline or fall in MAP to less than 65 mm of Hg will be noted and treated with Phenylephrine IV bolus of 50-100 Mcg. Intraoperatively any conversion to general anesthesia will also be noted.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 60 is below the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Pakistan Institute of Medical Sciences is the lead sponsor of 55 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group will receive Saddle block
Drug: Saddle block
Patients in this group will receive Spinal anesthesia
Drug: Spinal Anesthesia (bupivacaine)
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
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
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
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
Plan to share: No — Not allowed by ethical committee
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Pakistan Institute of Medical Sciences