Clinical trial NCT06313775: Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy
Official title: The Feasibility of Local Anesthesia for Bilateral Orchiectomy : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Orchiectomy
Spermatic Cord Block
Spinal Anesthesia
Pain Score
Prostate Cancer
Keywords: Prostate cancer
CaP
Bilateral orchiectomy
Spermatic cord block
pain score
spinal anesthesia
Lead sponsor: Sanpasitthiprasong Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-15
Enrollment: 18
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Simple random sampling
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: intraoperative pain score
timeFrame: Immediate postoperative assessment
Secondary outcomes:
measure: post-operative pain score
timeFrame: 1 hour after surgery
measure: morphine consumption
timeFrame: during 6 and 12 hour after surgery
measure: post-operative complications
timeFrame: 24 hour after surgery
Other outcomes:
Locations:
city: Ubon Ratchathani
country: Thailand
facility: Sanpasitthiprasong hospital
Study officials:
affiliation: Sanpasitthiprasong Hospital
name: Thararat Wanthawong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanpasitthiprasong Hospital
name: Wattanachai Ungjaroenwathana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanpasitthiprasong Hospital
name: Sahachart Atichosakun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanpasitthiprasong Hospital
name: Rawisara Hongkrisadakorn, MD
role: PRINCIPAL_INVESTIGATOR
References: