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

NCT ID: NCT03606811

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-05
• Study Completion Date: 2019-08-15

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.

Conditions

Intractable Pelvic Cancer Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

fluroscopic guided block

Group Type: ACTIVE_COMPARATOR

fluroscopic guided block

Intervention Type: PROCEDURE

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

double modality guided block

Group Type: EXPERIMENTAL

double modality (ultrasound and fluroscopic) guided block

Intervention Type: 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)

Interventions

fluroscopic guided block

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

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed H Othman

Assisstant professor of Anesthesia ICU and pain Relief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NCI, Cairo university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

IORG0003301

Identifier Type: -

Identifier Source: org_study_id