OrchiectomyNCT06313775
Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy
A study testing bilateral orchiectomy in people with Orchiectomy and Spermatic Cord Block, run by Sanpasitthiprasong Hospital at 1 site in Thailand.
Trial summary
The goal of this randomized controlled trial is to compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups in metastatic prostate cancer patient. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Orchiectomy, Spermatic Cord Block, Spinal Anesthesia
- What is being tested?
- bilateral orchiectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients of all ages diagnosed with prostate cancer undergoing treatment with bilateral orchiectomy
Who cannot join
- Patients with a history of Xylocaine allergy.
- Patients with uncorrected bleeding disorders.
- Patients with paralysis or neurosensory deficits
- Patients with dementia or cerebrovascular accidents (strokes) that impair communication.
- Patients with contraindications for epidural anesthesia, including:
- Patient refusal of spinal anesthesia.
Show all 12Show fewer
- Infection at the site of spinal injection.
- Allergy to specific types of local anesthetics, such as Hyperbaric bupivacaine.
- Inability of the patient to cooperate with the spinal anethetic procedure.
- Suspicion of high intracranial pressure based on abnormal physical examination.
- Aortic stenosis with fixed cardiac output.
- Low platelet count.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of Local Anesthesia for Bilateral Orchiectomy : a Randomized Controlled Trial
The goal of this randomized controlled trial is to compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups in metastatic prostate cancer patient. The main question it aims to answer are:
- Is there a difference in the level of pain during bilateral orchiectomy between spinal anesthesia and spermatic cord block?
Participants will undergo bilateral orchidectomy. They will be randomly assigned to two groups: the group receiving spinal anesthesia and the group receiving spermatic cord block If there is a comparison group: Researchers will compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications in both groups of patients.
Read the detailed description
Objective : To compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups.
Material and Method : This Randomized Controlled Trial that collected data from prostate cancer patients who underwent orchiectomy in our institution. Patients were randomly divided into two groups; SA and SCB. Data was collected on intraoperative pain score, 1 hour post-surgery, Morphine consumption during 6 and 12 hour after surgery and complications. All data was statistically analyzed using Independent t-test and Fisher's exact test.
Inclusion criteria : Patients of all ages diagnosed with prostate cancer undergoing treatment with bilateral orchiectomy.
Exclusion criteria :
- Patients with a history of Xylocaine allergy.
- Patients with uncorrected bleeding disorders.
- Patients with paralysis or neurosensory deficits
- Patients with dementia or cerebrovascular accidents (strokes) that impair communication.
- Patients with contraindications for spinal anesthesia, including:
- Patient refusal of spinal anesthesia.
- Infection at the site of spinal injection.
- Allergy to specific types of local anesthetics, such as Hyperbaric bupivacaine.
- Inability of the patient to cooperate with the spinal anesthetic procedure.
- Suspicion of high intracranial pressure based on abnormal physical examination.
- Aortic stenosis with fixed cardiac output.
- Low platelet count.
- Being tested
- bilateral orchiectomy
- Keywords
- Prostate cancer, CaP, Bilateral orchiectomy, Spermatic cord block, pain score, spinal anesthesia
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral orchiectomyProcedure or surgery
Bilateral simple orchiectomy is the surgical removal of both testicles through an incision in the scrotum.
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | Active comparator | spinal anesthesia : 0.5%hyperbaric bupivacaine 10-15 mg/dose injected at L3-L5 Receives: Procedure: bilateral orchiectomy |
| spermatic cord block | Experimental | 1%Xylocaine with adrenaline (Max 7 mg/kg/dose) divided to inject into each side of the spermatic cord 6-8 ml and infiltration into the scrotal incision area 3-4 ml. Receives: Procedure: bilateral orchiectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative pain score
Pain assessment is done using the verbal numerical rating scale, where patients rate their pain level from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable, without using any materials or equipment.
Measured: Immediate postoperative assessment
Secondary outcomes (3)
post-operative pain score
Pain assessment is done using the verbal numerical rating scale, where patients rate their pain level from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable, without using any materials or equipment.
Measured: 1 hour after surgery
morphine consumption
Morphine consumption after surgery
Measured: during 6 and 12 hour after surgery
post-operative complications
Postoperative complications assessment such as acute urinary retention and neurological complications like radiculopathy, neurological deficits, cauda equina syndrome, and paraplegia.
Measured: 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrchiectomyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simple random sampling
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanpasitthiprasong Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thararat Wanthawong, Sanpasitthiprasong Hospital
- Investigators
- Thararat Wanthawong, MD, Principal investigator, Sanpasitthiprasong HospitalWattanachai Ungjaroenwathana, MD, Principal investigator, Sanpasitthiprasong HospitalSahachart Atichosakun, MD, Principal investigator, Sanpasitthiprasong HospitalRawisara Hongkrisadakorn, MD, Principal investigator, Sanpasitthiprasong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313775
- Sponsor's protocol ID
- SPS005
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Local Anesthesia for Bilateral Orchiectomy : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06313775
- Acronym / sponsor ID
- SPS005
- Keywords
- Prostate cancer, CaP, Bilateral orchiectomy, Spermatic cord block, pain score, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Sanpasitthiprasong HospitalOther government
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Mar 2024 (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 randomized controlled trial is to compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups in metastatic prostate cancer patient. The main question it aims to answer are:
- Is there a difference in the level of pain during bilateral orchiectomy between spinal anesthesia and spermatic cord block?
Participants will undergo bilateral orchidectomy. They will be randomly assigned to two groups: the group receiving spinal anesthesia and the group receiving spermatic cord block If there is a comparison group: Researchers will compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications in both groups of patients.
Detailed description
Objective : To compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups.
Material and Method : This Randomized Controlled Trial that collected data from prostate cancer patients who underwent orchiectomy in our institution. Patients were randomly divided into two groups; SA and SCB. Data was collected on intraoperative pain score, 1 hour post-surgery, Morphine consumption during 6 and 12 hour after surgery and complications. All data was statistically analyzed using Independent t-test and Fisher's exact test.
Inclusion criteria : Patients of all ages diagnosed with prostate cancer undergoing treatment with bilateral orchiectomy.
Exclusion criteria :
- Patients with a history of Xylocaine allergy.
- Patients with uncorrected bleeding disorders.
- Patients with paralysis or neurosensory deficits
- Patients with dementia or cerebrovascular accidents (strokes) that impair communication.
- Patients with contraindications for spinal anesthesia, including:
- Patient refusal of spinal anesthesia.
- Infection at the site of spinal injection.
- Allergy to specific types of local anesthetics, such as Hyperbaric bupivacaine.
- Inability of the patient to cooperate with the spinal anesthetic procedure.
- Suspicion of high intracranial pressure based on abnormal physical examination.
- Aortic stenosis with fixed cardiac output.
- Low platelet count.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Simple random sampling
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | Active comparator | Procedure: bilateral orchiectomyspinal anesthesia : 0.5%hyperbaric bupivacaine 10-15 mg/dose injected at L3-L5 |
| spermatic cord block | Experimental | Procedure: bilateral orchiectomy1%Xylocaine with adrenaline (Max 7 mg/kg/dose) divided to inject into each side of the spermatic cord 6-8 ml and infiltration into the scrotal incision area 3-4 ml. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of all ages diagnosed with prostate cancer undergoing treatment with bilateral orchiectomy
Key exclusion criteria (12 listed)
- Patients with a history of Xylocaine allergy.
- Patients with uncorrected bleeding disorders.
- Patients with paralysis or neurosensory deficits
- Patients with dementia or cerebrovascular accidents (strokes) that impair communication.
- Patients with contraindications for epidural anesthesia, including:
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 |
|---|---|---|
| bilateral orchiectomyBilateral simple orchiectomy is the surgical removal of both testicles through an incision in the scrotum. | Procedure or surgery | Spinal anesthesia, spermatic cord block |
Primary outcome
intraoperative pain score
Time frame: Immediate postoperative assessment
Pain assessment is done using the verbal numerical rating scale, where patients rate their pain level from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable, without using any materials or equipment.
3 secondary outcomes
post-operative pain score
Time frame: 1 hour after surgery
morphine consumption
Time frame: during 6 and 12 hour after surgery
post-operative complications
Time frame: 24 hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Thararat Wanthawong, MD principal investigator
Sanpasitthiprasong Hospital
Wattanachai Ungjaroenwathana, MD principal investigator
Sanpasitthiprasong Hospital
Sahachart Atichosakun, MD principal investigator
Sanpasitthiprasong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral orchiectomy in people with Orchiectomy and Spermatic Cord Block, run by Sanpasitthiprasong Hospital at 1 site in Thailand.
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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 Thailand. 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.
Are results available for this study?
Results are not available in the source record.
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?
intraoperative pain score (time frame: Immediate postoperative assessment). 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 15 Mar 2024.