TURP(Transurethral Resection of Prostate)Phase 4NCT07841184
Modified Saddle Block vs Spinal Anesthesia for TURP
A Phase 4 study testing Saddle block and Spinal Anesthesia (bupivacaine) in people with TURP(Transurethral Resection of Prostate) and Spinal Anesthesia, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- TURP(Transurethral Resection of Prostate), Spinal Anesthesia, Saddle Block Anesthesia
- What is being tested?
- Saddle block and Spinal Anesthesia (bupivacaine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Aug 2026to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40- 90 years
- Elective TURP surgery under Neuraxial Anesthesia
- ASA class I and II
Who cannot join
- Contraindication to Neuraxial anesthesia
- Allergic to study medications
- Lack of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Department of Anesthesia Principal Investigator, MBBS,FCPS contact
Pakistan1 site, 1 recruiting
- Recruiting
Deparmtent of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences
Islamabad, Federal, 44000
Naheed Fatima Head of Department, MBBS,FCPS,MHPE, +92 300 5236655, naheedfk73@gmail.com
About this study
Official title: Comparison of Modified Saddle Block With Spinal Anesthesia Among Patients Undergoing Transurethral Resection of Prostate Cancer; A Randomized Control Trial at a Tertiary Care Hospital
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.
Read the detailed description
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.
- Conditions
- TURP(Transurethral Resection of Prostate), Spinal Anesthesia, Saddle Block Anesthesia, Hypotension During Surgery
- Being tested
- Saddle block, Spinal Anesthesia (bupivacaine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saddle blockDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Group Saddle | Active comparator | Patients in this group will receive Saddle block Receives: Drug: Saddle block |
| Group Spinal anesthesia | Active comparator | Patients in this group will receive Spinal anesthesia Receives: Drug: Spinal Anesthesia (bupivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Peri-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start25 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TURP(Transurethral Resection of Prostate)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Department of Anesthesia, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841184
- Sponsor's protocol ID
- F5-2/2024(ERRC)/PIMS
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed by ethical committee
Publications
Shahid N, Iqbal MW, Haque SN, Rashid AM, Shaukat S. Effectiveness Of Saddle Block Vs Spinal Anaesthesia In Turp: An Open Label Randomized Control Trial. J Ayub Med Coll Abbottabad. 2023 Feb-Mar;35(1):127-132. doi: 10.55519/JAMC-01-11451.
PubMed 36849392
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Modified Saddle Block With Spinal Anesthesia Among Patients Undergoing Transurethral Resection of Prostate Cancer; A Randomized Control Trial at a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT07841184
- Acronym / sponsor ID
- F5-2/2024(ERRC)/PIMS
- Conditions
- TURP(Transurethral Resection of Prostate), Spinal Anesthesia, Saddle Block Anesthesia, Hypotension During Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Saddle | Active comparator | Drug: Saddle blockPatients in this group will receive Saddle block |
| Group Spinal anesthesia | Active comparator | Drug: Spinal Anesthesia (bupivacaine)Patients in this group will receive Spinal anesthesia |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40- 90 years
- Elective TURP surgery under Neuraxial Anesthesia
- ASA class I and II
Key exclusion criteria (3 listed)
- Contraindication to Neuraxial anesthesia
- Allergic to study medications
- Lack of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saddle blockPatients 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 | Drug | Group Saddle |
| Spinal Anesthesia (bupivacaine)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 | Drug | Group Spinal anesthesia |
Primary outcome
Maximum fall in Mean Arterial Pressure
Time frame: Peri-operative from From induction of anesthesia until completion of surgery
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.
1 secondary outcome
Conversion rate to General Anesthesia
Time frame: Peri-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 36849392Shahid N, Iqbal MW, Haque SN, Rashid AM, Shaukat S. Effectiveness Of Saddle Block Vs Spinal Anaesthesia In Turp: An Open Label Randomized Control Trial. J Ayub Med Coll Abbottabad. 2023 Feb-Mar;35(1):127-132. doi: 10.55519/JAMC-01-11451.
- Individual participant dataSharing planned: No. Not allowed by ethical committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Anesthesia Principal Investigator, MBBS,FCPS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saddle block and Spinal Anesthesia (bupivacaine) in people with TURP(Transurethral Resection of Prostate) and Spinal Anesthesia, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Department of Anesthesia Principal Investigator, MBBS,FCPS (+92-333-5236956, departmentofanesthesiapims@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum fall in Mean Arterial Pressure (time frame: Peri-operative from From induction of anesthesia until completion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07841184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.