Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06313775
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-15
First Post:
2024-03-01
Brief Title:
Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy
Sponsor:
Sanpasitthiprasong Hospital
Organization:
Sanpasitthiprasong Hospital
Study Overview
Official Title:
The Feasibility of Local Anesthesia for Bilateral Orchiectomy a Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Fishers 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
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 Fishers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None