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OpenTrials
Completed

NCT Number: NCT03606811

Fluoroscopic &Ultrasonographic Guidance of Superior Hypogastric Plexus Neurolysis in Intractable Pelvic Pain

fluoroscopic group & includes 30 patients where SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.the double modality group & includes 30 patients where SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NCI, Cairo university

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • Intractable pelvic cancer pain (VAS > 40 mm)
  • Pain is refractory to pharmacotherapy (both opioids and adjuvant therapy) or opioids' side effects are not tolerated.

Exclusion criteria

  • Local or systemic sepsis.
  • Uncorrectable coagulopathy.
  • Neuropsychiatric illness.
  • History of drug abuse.
  • Pregnant or lactating patients.
  • Distorted local anatomy.
  • Patients who are known to be allergic to the used medications.
  • Cardiovascular or respiratory instability.

Treatment and study plan

fluroscopic guided block

Procedure

SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.

double modality (ultrasound and fluroscopic) guided block

Procedure

SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position. Then C-arm pictures will be checked (both P-A & dead lateral)

Primary outcomes

  1. pain relief will be assessed by VAS

    Time frame: 12 weeks

    pain relief will be assessed by VAS (visual Analogue score) which is 100 mscale with left (0) end means no pain & right (10) end means the worst possible pain

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Role of Double Modality " Fluoroscopic &Ultrasonographic " Guidance of Superior Hypogastric Plexus Neurolysis in Treating Intractable Pelvic Cancer Pain: a Comparative Study.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2018
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.