Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain

Mansoura University

Status and phase: Enrolling; Phase 2

Conditions: Pain Cancer

Treatments: Other: Group US-guided; Other: Group fluoroscopy-guided

Study type: Interventional

Funder types: Other

Identifiers

NCT05299047

R.22.01.1598

Details and patient eligibility

About

Cancer related pelvic pain can be debilitating and difficult to treat. Superior hypogastric plexus neurolysis (SHPN) is considered to be an option for adequately relieving pain, with fewer side effects and improving the quality of life

Full description

The superior hypogastric plexus (SHP) is one of the paravertebral sympathetic ganglia, located in the lower border of the L5 vertebra and upper part of the sacrum in the retroperitoneal space. It is considered as a continuity of the celiac plexus and the lumbar sympathetic ganglia. It is related to the bifurcation of the aorta and the ureters. The SHP has a sympathetic connection (both efferent and afferent fibers) with splanchnic nerves and aortic plexus. It innervates the viscera of the pelvis, including the urinary bladder, ureters, sigmoid colon down to the anal canal, and upper vagina SHP blockade can be performed either by ultrasound (US), fluoroscopic, computed tomography (CT) and Magnetic resonance imaging (MRI) techniques and it is conducted through anterior (transabdominal) or posterior (lateral, paramedian, oblique, transdiscal, or transvaginal) approaches These different imaging modalities and approaches have been described for SHPN to make it easier, safer and more accurate and satisfied to the patients

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients more than 18 years old of both genders with cancer-related pelvic pain,
• poor pain control or severe side effects with opioid therapy,
• ≥ 4 on a numeric rating scale (NRS) of pain that ranged from 0 (no pain) to 10 (extreme pain).,
• American society of Anesthesiology Physical Status class I and II,
• positive diagnostic block day before the procedure by injecting a local anesthetic (0.25% bupivacaine 10 ml)
• Body mass index ˂ 30 were included in this study.

Exclusion criteria

• patient refusal,
• local or systemic sepsis,
• coagulopathy,
• unstable cardiovascular and respiratory diseases,
• previous neurological deficits,
• history of psychiatric disorders,
• history of drug abuse,
• distorted local anatomy,
• those who were allergic to the used medications were excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Group US-guided

Active Comparator group

Description:

will receive superior hypogastric plexus neurolysis by the US-guided anterior approach

Treatment:

Other: Group US-guided

- Group fluoroscopy-guided

Active Comparator group

Description:

will receive superior hypogastric plexus neurolysis by the fluoroscopy-guided anterior approach

Treatment:

Other: Group fluoroscopy-guided