Benign Prostatic Hyperplasia Postoperative PainPhase 4NCT07113782
Comparison of Magnesium Sulphate vs Tramadol as Adjuvants in Intrathecal Bupivacaine for Postoperative Pain in TURP Patients
A Phase 4 study testing 1. Magnesium Sulphate 2. Tramadol in people with Benign Prostatic Hyperplasia Postoperative Pain, run by Armed Forces Institute of Urology, Rawalpindi at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to determine whether adding magnesium sulfate or tramadol to intrathecal bupivacaine improves postoperative pain control and hemodynamic stability in adult male patients undergoing transurethral resection of the prostate (TURP). Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia Postoperative Pain
- What is being tested?
- 1. Magnesium Sulphate 2. Tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2024to 30 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients aged 50 to 80 years
- Scheduled for elective transurethral resection of the prostate (TURP)
- American Society of Anesthesiologists (ASA) physical status I-II
- Provided written informed consent
Who cannot join
- Known allergy or hypersensitivity to bupivacaine, tramadol, or magnesium sulfate
- Contraindications to spinal anesthesia (e.g., coagulopathy, infection at the injection site)
- History of chronic opioid use or substance abuse
- Severe hepatic, renal, or cardiac disease
- Neurological or psychiatric disorders affecting pain perception or reporting
- Participation in another clinical trial within the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to determine whether adding magnesium sulfate or tramadol to intrathecal bupivacaine improves postoperative pain control and hemodynamic stability in adult male patients undergoing transurethral resection of the prostate (TURP).
The main questions this study aims to answer are:
Read more
Does the addition of magnesium sulfate or tramadol prolong the duration of postoperative analgesia compared to bupivacaine alone?
Does either adjuvant provide better intraoperative hemodynamic stability?
Researchers will compare two groups:
One group receiving magnesium sulfate plus bupivacaine
Another group receiving tramadol plus bupivacaine
to see which combination is more effective for pain control and hemodynamic outcomes.
Participants will:
Receive spinal anesthesia with either magnesium sulfate or tramadol added to bupivacaine.
Be monitored during surgery for heart rate, blood pressure, and other vital signs.
Be assessed after surgery for pain levels and time until first request for additional pain medication.
Read the detailed description
This retrospective, randomized, double-blind clinical trial was conducted to compare the efficacy and safety of magnesium sulfate and tramadol as intrathecal adjuvants to hyperbaric bupivacaine in male patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia.
The primary aim was to evaluate:
The duration of postoperative analgesia, defined as the time from the completion of surgery to the patient's first request for rescue analgesia.
Intraoperative hemodynamic stability, assessed by monitoring mean arterial pressure, heart rate, and the incidence of hypotension or bradycardia.
A total of 60 adult male patients, aged 50 to 80 years, undergoing elective TURP were randomly allocated into two groups (30 patients each):
Group M (Magnesium Group): Received 12.5 mg of 0.5% hyperbaric bupivacaine with 50 mg of magnesium sulfate intrathecally.
Group T (Tramadol Group): Received 12.5 mg of 0.5% hyperbaric bupivacaine with 20 mg of tramadol intrathecally.
All patients received spinal anesthesia at the L3-L4 or L4-L5 interspace under aseptic conditions. Intraoperative monitoring included ECG, non-invasive blood pressure, and pulse oximetry. Data on hemodynamic parameters were collected at regular intervals throughout the procedure.
Primary Outcome Measures:
Time to first postoperative analgesic request (in minutes)
Mean arterial pressure and heart rate during the procedure
Secondary Outcome Measures:
Time to two-segment regression of the sensory block
Incidence of adverse events including hypotension, bradycardia, nausea, vomiting, pruritus, urinary retention, and respiratory depression
Blinding was maintained for both patients and the investigator recording postoperative outcomes.
The study was conducted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. Ethical approval was obtained from the Institutional Review Board of Armed Forces Institute of Urology (AFIU), Rawalpindi. Written informed consent was obtained from all participants prior to inclusion in the study.
This trial was completed before registration and is being submitted retrospectively for transparency and publication compliance.
- Being tested
- 1. Magnesium Sulphate 2. Tramadol
- Keywords
- Magnesium sulphate, Tramadol, Intrathecal anesthesia, Bupivacaine, TURP, Postoperative pain, Hemodynamic stability
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Magnesium Sulphate 2. TramadolDrug
Magnesium Sulphate (Group M): 50 mg magnesium sulphate added to 12.5 mg of 0.5% hyperbaric bupivacaine, administered intrathecally.
Tramadol (Group T): 25 mg tramadol added to 12.5 mg of 0.5% hyperbaric bupivacaine, administered intrathecally.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Group M (Magnesium Sulphate) | Experimental | Patients receive 12.5 mg of 0.5% hyperbaric bupivacaine with 50 mg (0.1 mL) magnesium sulphate intrathecally.
Intervention Name: Magnesium sulphate Receives: Drug: 1. Magnesium Sulphate 2. Tramadol |
| Active Comparator - Group T (Tramadol) | Active comparator | Patients receive 12.5 mg of 0.5% hyperbaric bupivacaine with 25 mg (0.5 mL) tramadol intrathecally.
Intervention Name: Tramadol Receives: Drug: 1. Magnesium Sulphate 2. Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative analgesia
Time (in minutes) from administration of intrathecal drug to the first request for rescue analgesia (VAS ≥ 4).
Measured: Up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Nov 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a randomized, controlled, parallel assignment interventional model in which participants were allocated into two groups. One group received intrathecal bupivacaine with magnesium sulphate, and the other received bupivacaine with tramadol. The interventions were administered once and compared for postoperative analgesia and hemodynamic stability without crossover.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Urology, Rawalpindi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jawad Ul Hassan, Armed Forces Institute of Urology, Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113782
- Sponsor's protocol ID
- Trg 1/RB/2024/008
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Magnesium Sulphate vs Tramadol as Adjuvants in Intrathecal Bupivacaine for Postoperative Pain in TURP Patients
- ClinicalTrials.gov ID
- NCT07113782
- Acronym / sponsor ID
- Trg 1/RB/2024/008
- Keywords
- Magnesium sulphate, Tramadol, Intrathecal anesthesia, Bupivacaine, TURP, Postoperative pain, Hemodynamic stability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Armed Forces Institute of Urology, RawalpindiUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Aug 2025 (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.
The goal of this clinical trial is to determine whether adding magnesium sulfate or tramadol to intrathecal bupivacaine improves postoperative pain control and hemodynamic stability in adult male patients undergoing transurethral resection of the prostate (TURP).
The main questions this study aims to answer are:
Does the addition of magnesium sulfate or tramadol prolong the duration of postoperative analgesia compared to bupivacaine alone?
Does either adjuvant provide better intraoperative hemodynamic stability?
Researchers will compare two groups:
One group receiving magnesium sulfate plus bupivacaine
Another group receiving tramadol plus bupivacaine
to see which combination is more effective for pain control and hemodynamic outcomes.
Participants will:
Receive spinal anesthesia with either magnesium sulfate or tramadol added to bupivacaine.
Be monitored during surgery for heart rate, blood pressure, and other vital signs.
Be assessed after surgery for pain levels and time until first request for additional pain medication.
Detailed description
This retrospective, randomized, double-blind clinical trial was conducted to compare the efficacy and safety of magnesium sulfate and tramadol as intrathecal adjuvants to hyperbaric bupivacaine in male patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia.
The primary aim was to evaluate:
The duration of postoperative analgesia, defined as the time from the completion of surgery to the patient's first request for rescue analgesia.
Intraoperative hemodynamic stability, assessed by monitoring mean arterial pressure, heart rate, and the incidence of hypotension or bradycardia.
A total of 60 adult male patients, aged 50 to 80 years, undergoing elective TURP were randomly allocated into two groups (30 patients each):
Group M (Magnesium Group): Received 12.5 mg of 0.5% hyperbaric bupivacaine with 50 mg of magnesium sulfate intrathecally.
Group T (Tramadol Group): Received 12.5 mg of 0.5% hyperbaric bupivacaine with 20 mg of tramadol intrathecally.
All patients received spinal anesthesia at the L3-L4 or L4-L5 interspace under aseptic conditions. Intraoperative monitoring included ECG, non-invasive blood pressure, and pulse oximetry. Data on hemodynamic parameters were collected at regular intervals throughout the procedure.
Primary Outcome Measures:
Time to first postoperative analgesic request (in minutes)
Mean arterial pressure and heart rate during the procedure
Secondary Outcome Measures:
Time to two-segment regression of the sensory block
Incidence of adverse events including hypotension, bradycardia, nausea, vomiting, pruritus, urinary retention, and respiratory depression
Blinding was maintained for both patients and the investigator recording postoperative outcomes.
The study was conducted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. Ethical approval was obtained from the Institutional Review Board of Armed Forces Institute of Urology (AFIU), Rawalpindi. Written informed consent was obtained from all participants prior to inclusion in the study.
This trial was completed before registration and is being submitted retrospectively for transparency and publication compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study used a randomized, controlled, parallel assignment interventional model in which participants were allocated into two groups. One group received intrathecal bupivacaine with magnesium sulphate, and the other received bupivacaine with tramadol. The interventions were administered once and compared for postoperative analgesia and hemodynamic stability without crossover.
| Arm | Type | Receives |
|---|---|---|
| Experimental - Group M (Magnesium Sulphate) | Experimental | Drug: 1. Magnesium Sulphate 2. TramadolPatients receive 12.5 mg of 0.5% hyperbaric bupivacaine with 50 mg (0.1 mL) magnesium sulphate intrathecally. Intervention Name: Magnesium sulphate |
| Active Comparator - Group T (Tramadol) | Active comparator | Drug: 1. Magnesium Sulphate 2. TramadolPatients receive 12.5 mg of 0.5% hyperbaric bupivacaine with 25 mg (0.5 mL) tramadol intrathecally. Intervention Name: Tramadol |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients aged 50 to 80 years
- Scheduled for elective transurethral resection of the prostate (TURP)
- American Society of Anesthesiologists (ASA) physical status I-II
- Provided written informed consent
Key exclusion criteria (6 listed)
- Known allergy or hypersensitivity to bupivacaine, tramadol, or magnesium sulfate
- Contraindications to spinal anesthesia (e.g., coagulopathy, infection at the injection site)
- History of chronic opioid use or substance abuse
- Severe hepatic, renal, or cardiac disease
- Neurological or psychiatric disorders affecting pain perception or reporting
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 |
|---|---|---|
| 1. Magnesium Sulphate 2. TramadolMagnesium Sulphate (Group M): 50 mg magnesium sulphate added to 12.5 mg of 0.5% hyperbaric bupivacaine, administered intrathecally. Tramadol (Group T): 25 mg tramadol added to 12.5 mg of 0.5% hyperbaric bupivacaine, administered intrathecally. | Drug | Active Comparator - Group T (Tramadol), Experimental - Group M (Magnesium Sulphate) |
Primary outcome
Duration of postoperative analgesia
Time frame: Up to 24 hours postoperatively
Time (in minutes) from administration of intrathecal drug to the first request for rescue analgesia (VAS ≥ 4).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 1. Magnesium Sulphate 2. Tramadol in people with Benign Prostatic Hyperplasia Postoperative Pain, run by Armed Forces Institute of Urology, Rawalpindi 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 11 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative analgesia (time frame: Up to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2025.