Orchiectomy, Pain Score, Prostate Cancer, Spermatic Cord Block, Spinal Anesthesia
Conditions
Keywords
Prostate cancer, CaP, Bilateral orchiectomy, Spermatic cord block, pain score, spinal anesthesia
Brief 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. 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 : 1. Patients with a history of Xylocaine allergy. 2. Patients with uncorrected bleeding disorders. 3. Patients with paralysis or neurosensory deficits 4. Patients with dementia or cerebrovascular accidents (strokes) that impair communication. 5. 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.
Interventions
PROCEDUREbilateral orchiectomy
Bilateral simple orchiectomy is the surgical removal of both testicles through an incision in the scrotum.
Sponsors
Sanpasitthiprasong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Simple random sampling
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
Inclusion criteria
* Patients of all ages diagnosed with prostate cancer undergoing treatment with bilateral orchiectomy
Exclusion criteria
1. Patients with a history of Xylocaine allergy. 2. Patients with uncorrected bleeding disorders. 3. Patients with paralysis or neurosensory deficits 4. Patients with dementia or cerebrovascular accidents (strokes) that impair communication. 5. Patients with contraindications for epidural 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 anethetic procedure. * Suspicion of high intracranial pressure based on abnormal physical examination. * Aortic stenosis with fixed cardiac output. * Low platelet count.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative pain score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post-operative pain score | 1 hour after surgery | 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. |
| morphine consumption | during 6 and 12 hour after surgery | Morphine consumption after surgery |
| post-operative complications | 24 hour after surgery | Postoperative complications assessment such as acute urinary retention and neurological complications like radiculopathy, neurological deficits, cauda equina syndrome, and paraplegia. |
Countries
Thailand
Outcome results
None listed