Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy

NCT06313775 | Enrolling By Invitation

• 1 other identifier: SPS005
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Orchiectomy; Spermatic Cord Block; Spinal Anesthesia; Pain Score; Prostate Cancer

Keywords

Prostate cancer; CaP; Bilateral orchiectomy; Spermatic cord block; pain score; spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• post-operative pain score

  1 hour after surgery

• morphine consumption

  during 6 and 12 hour after surgery

• post-operative complications

  24 hour after surgery

Study Arms (2)

Spinal anesthesia

ACTIVE COMPARATOR

spinal anesthesia : 0.5%hyperbaric bupivacaine 10-15 mg/dose injected at L3-L5

Procedure: bilateral orchiectomy

spermatic cord block

EXPERIMENTAL

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

Interventions

bilateral orchiectomy PROCEDURE

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

Spinal anesthesia; spermatic cord block

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of all ages diagnosed with prostate cancer undergoing treatment with bilateral orchiectomy

You may not qualify if:

• Patients with a history of Xylocaine allergy.
• Patients with uncorrected bleeding disorders.
• Patients with paralysis or neurosensory deficits
• Patients with dementia or cerebrovascular accidents (strokes) that impair communication.
• 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.

Sponsors & Collaborators

• Sanpasitthiprasong Hospital: lead

Study Sites (1)

Sanpasitthiprasong hospital

Ubon Ratchathani, 33000, Thailand

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Castration

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Urology department, Sunpasitthiprasong hospital, Ubonratchathani, Thailand

Model Details: Simple random sampling

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 15, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)