Ultrasound Versus Fluoroscopy Guided Superior Hypogastric Plexus Block in Cancer Bladder Patients
NCT ID: NCT05083702
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-12-01
2021-10-30
Brief Summary
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Detailed Description
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To compare Fluoroscopic guided transdiscal superior hypogastric block and Ultrasound guided superior hypogastric block regarding their efficacy to control pelvic pain and
Statistical analysis:
Data will be described as mean ±SD or as frequencies (number of cases) and percentages when appropriate. Comparison of numerical variables between two study groups will be carried out using parametric and non-parametric t- tests for independent samples. Within group comparison of numerical variables was carried out using repeated measures ANOVA. P values of less than 0.05 will be statistically significant. All statistical calculations are performed using statistical package for the social sciences (SPSS, version 23 for Microsoft Windows; SPSS Inc., Chicago, Illinois, USA)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Fluoroscopy-guided superior hypogastric plexus block transdiscal approach
fluroscopy guided superior hypogastric plexus block transdiscal approach for chronic pain treatment in cancer bladder VAS score and morphine consumption are measured before and after 1 day , 1 month , 3 monthes
Fluoroscopy-guided superior hypogastric plexus block transdiscal approach
Patient lies prone, L5-S1 interspace identified under fluoroscopy, the skin is prepared and sterile drapes are placed after local anesthetic infiltration of the skin the subcutaneous tissue with 2% lidocaine a 20 guage, 15 cm needle with short bevel is inserted at the center of L5- S1 interlaminar space under anteroposterior fluoroscopic vision. The needle is then advanced toward the intervertebral disc. After confirmation, the needle is advanced through the intervertebral disc until it exists at its anterior surface confirmed by administration of 4 ml of soluble contrast media in both lateral and anteroposterior fluoroscopic view. Neurolysis is performed with 8 ml 8 % phenol solution. After neurolysis, 0.5 ml of saline is given to avoid the deposition of phenol within the intervertebral disc material. While withdrawing, the needle cephazoline 50 mg in 1 ml is injected into the disc.
ultrasound-guided superior hypogastric plexus block
ultrasound guided superior hypogastric plexus block in treatment of chronic pain in cancer badder VAS score and morphine consumption are measured before and after 1 day , 1 month , 3 monthes
ultrasound-guided superior hypogastric plexus block
Patients are placed in the supine position and after sterilization, the low-frequency curved probe is used in the longitudinal axis to visualize the aortic bifurcation and is identified using a longitudinal Ultra-Sound (Phillips Healthcare, Andover, Massachusetts, US). Next, the probe is placed deeply transverse till aorta end and bifurcation seen of iliac vessels once seen we enter out of plane and inject.as it lies in front the vertebral body of the L5 vertebra. Local infiltration with 1% lidocaine is obtained at port of entry 1-1.5 inches below the umbilicus. A 15-cm, 22-G Chiba needle is inserted (out-of-plane) and advanced by avoiding vascular structures until contact with the L5-body. The needle will be withdrawan the 1-2 mm and inject 8 ml 8% phenol in saline. Finally, 0.5 ml of lidocaine is injected during Chiba needle removal
Interventions
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Fluoroscopy-guided superior hypogastric plexus block transdiscal approach
Patient lies prone, L5-S1 interspace identified under fluoroscopy, the skin is prepared and sterile drapes are placed after local anesthetic infiltration of the skin the subcutaneous tissue with 2% lidocaine a 20 guage, 15 cm needle with short bevel is inserted at the center of L5- S1 interlaminar space under anteroposterior fluoroscopic vision. The needle is then advanced toward the intervertebral disc. After confirmation, the needle is advanced through the intervertebral disc until it exists at its anterior surface confirmed by administration of 4 ml of soluble contrast media in both lateral and anteroposterior fluoroscopic view. Neurolysis is performed with 8 ml 8 % phenol solution. After neurolysis, 0.5 ml of saline is given to avoid the deposition of phenol within the intervertebral disc material. While withdrawing, the needle cephazoline 50 mg in 1 ml is injected into the disc.
ultrasound-guided superior hypogastric plexus block
Patients are placed in the supine position and after sterilization, the low-frequency curved probe is used in the longitudinal axis to visualize the aortic bifurcation and is identified using a longitudinal Ultra-Sound (Phillips Healthcare, Andover, Massachusetts, US). Next, the probe is placed deeply transverse till aorta end and bifurcation seen of iliac vessels once seen we enter out of plane and inject.as it lies in front the vertebral body of the L5 vertebra. Local infiltration with 1% lidocaine is obtained at port of entry 1-1.5 inches below the umbilicus. A 15-cm, 22-G Chiba needle is inserted (out-of-plane) and advanced by avoiding vascular structures until contact with the L5-body. The needle will be withdrawan the 1-2 mm and inject 8 ml 8% phenol in saline. Finally, 0.5 ml of lidocaine is injected during Chiba needle removal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with advanced stage cancer bladder.
* Patient with severe pain (VAS) 7 or more .
* Patients don't receive any strong opioids for pain at least 2 weeks
Exclusion Criteria
* Local infection at the puncture site.
* Coagulopathy.
* Cognitive disorders.
* Unstable cardiovascular disease.
* History of psychiatric disorders.
* History of drug abuse.
* Patients allergic to medication used.
* Patients with any contraindications to drugs and dye used.
20 Years
ALL
No
Sponsors
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National Cancer Institute, Egypt
OTHER
Responsible Party
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Principal Investigators
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Khaled Mostafa
Role: STUDY_DIRECTOR
National Cancer Institute (NCI)
Locations
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National cancer institute
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AP2103-30101R
Identifier Type: -
Identifier Source: org_study_id