Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy

Prostate Cancer Clinical Trial

Official title:

The Feasibility of Local Anesthesia for Bilateral Orchiectomy : a Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06313775
• Other study ID #: SPS005
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Sanpasitthiprasong Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 18
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Orchiectomy
• Pain Score
• Prostate Cancer
• Prostatic Neoplasms
• Spermatic Cord Block
• Spinal Anesthesia

Intervention

Procedure:
• bilateral orchiectomy
Bilateral simple orchiectomy is the surgical removal of both testicles through an incision in the scrotum.

Locations

Country	Name	City	State
Thailand	Sanpasitthiprasong hospital	Ubon Ratchathani

Sponsors (1)

Lead Sponsor	Collaborator
Sanpasitthiprasong Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	morphine consumption	Morphine consumption after surgery	during 6 and 12 hour after surgery
Secondary	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