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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03606811
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12.3
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: fluroscopic guided block
  • Procedure: double modality (ultrasound and fluroscopic) guided block
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Role of Double Modality " Fluoroscopic &Ultrasonographic " Guidance of Superior Hypogastric Plexus Neurolysis in Treating Intractable Pelvic Cancer Pain: a Comparative Study.
Actual Study Start Date :
Aug 5, 2018
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: fluroscopic guided block

Procedure: fluroscopic guided block
SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.
Experimental: double modality guided block

Procedure: double modality (ultrasound and fluroscopic) guided block
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)

Outcome Measures

Primary Outcome Measures

  1. pain relief will be assessed by VAS [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NCI, Cairo university Cairo Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed H Othman, Assisstant professor of Anesthesia ICU and pain Relief, Assiut University
ClinicalTrials.gov Identifier:
NCT03606811
Other Study ID Numbers:
  • IORG0003301
First Posted:
Jul 31, 2018
Last Update Posted:
Jan 14, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pelvic Neoplasms
Cancer Pain

Study Results

No Results Posted as of Jan 14, 2020