Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prostate Cancer; Spinal Anesthesia; Pain Score; Orchiectomy; Spermatic Cord Block
• Intervention / Treatment: Procedure: bilateral orchiectomy

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 Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Ubon Ratchathani, Thailand, 33000
    • Sanpasitthiprasong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Spinal anesthesia; spinal anesthesia : 0.5%hyperbaric bupivacaine 10-15 mg/dose injected at L3-L5	Procedure: bilateral orchiectomy; Bilateral simple orchiectomy is the surgical removal of both testicles through an incision in the scrotum.
Experimental: spermatic cord block; 1%Xylocaine with adrenaline (Max 7 mg/kg/dose) divided to inject into each side of the spermatic cord 6-8 ml and infiltration into the scrotal incision area 3-4 ml.	Procedure: bilateral orchiectomy; Bilateral simple orchiectomy is the surgical removal of both testicles through an incision in the scrotum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
morphine consumption	Morphine consumption after surgery	during 6 and 12 hour after surgery
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

Collaborators and Investigators

• Sponsor: Sanpasitthiprasong Hospital
• Investigators: Principal Investigator: Thararat Wanthawong, MD, Sanpasitthiprasong Hospital; Principal Investigator: Wattanachai Ungjaroenwathana, MD, Sanpasitthiprasong Hospital; Principal Investigator: Sahachart Atichosakun, MD, Sanpasitthiprasong Hospital; Principal Investigator: Rawisara Hongkrisadakorn, MD, Sanpasitthiprasong Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 9, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Prostate cancer; spinal anesthesia; pain score; Bilateral orchiectomy; CaP; Spermatic cord block
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SPS005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No