Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy

Not Applicable

• Conditions: Prostate Cancer; Spinal Anesthesia; Pain Score; Orchiectomy; Spermatic Cord Block

• Registration Number: NCT06313775
• Lead Sponsor: Sanpasitthiprasong Hospital

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-09
• Last Update Submitted: 2024-03-09
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Study Start: 2024-06-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sanpasitthiprasong hospital; 🇹🇭 Ubon Ratchathani, Thailand