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Trial Title:
Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy
NCT ID:
NCT06313775
Condition:
Orchiectomy
Spermatic Cord Block
Spinal Anesthesia
Pain Score
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate cancer
CaP
Bilateral orchiectomy
Spermatic cord block
pain score
spinal anesthesia
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Simple random sampling
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
bilateral orchiectomy
Description:
Bilateral simple orchiectomy is the surgical removal of both testicles through an
incision in the scrotum.
Arm group label:
Spinal anesthesia
Arm group label:
spermatic cord block
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sanpasitthiprasong hospital
Address:
City:
Ubon Ratchathani
Zip:
33000
Country:
Thailand
Start date:
June 1, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Sanpasitthiprasong Hospital
Agency class:
Other
Source:
Sanpasitthiprasong Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313775
