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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal anesthesia | Active Comparator | spinal anesthesia : 0.5%hyperbaric bupivacaine 10-15 mg/dose injected at L3-L5 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bilateral orchiectomy | Procedure | Bilateral simple orchiectomy is the surgical removal of both testicles through an incision in the scrotum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediate postoperative assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour after surgery |
| morphine consumption |
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Inclusion Criteria:
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 epidural anesthesia, including:
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| Name | Affiliation | Role |
|---|---|---|
| Thararat Wanthawong, MD | Sanpasitthiprasong Hospital | Principal Investigator |
| Wattanachai Ungjaroenwathana, MD | Sanpasitthiprasong Hospital | Principal Investigator |
| Sahachart Atichosakun, MD | Sanpasitthiprasong Hospital | Principal Investigator |
| Rawisara Hongkrisadakorn, MD | Sanpasitthiprasong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanpasitthiprasong hospital | Ubon Ratchathani | 33000 | Thailand |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002369 | Castration |
| ID | Term |
|---|---|
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013519 | Urogenital Surgical Procedures |
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Simple random sampling
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Morphine consumption after surgery |
| 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. | 24 hour after surgery |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |