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

Phase 2

• Conditions: Pain Cancer
• Interventions: Other: Group US-guided; Other: Group fluoroscopy-guided

• Registration Number: NCT05299047
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Primary Completion: 2022-05-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-13
• Last Update Posted: 2022-08-16
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group US-guided	Group US-guided	will receive superior hypogastric plexus neurolysis by the US-guided anterior approach
- Group fluoroscopy-guided	Group fluoroscopy-guided	will receive superior hypogastric plexus neurolysis by the fluoroscopy-guided anterior approach

Primary Outcome Measures

Name	Time	Method
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)	3 months from block	It includes the assessment of 10 symptoms experienced by cancer patients with the following 0-10 numeric rating scales: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, feeling of well-being, and insomnia

Secondary Outcome Measures

Name	Time	Method
time of the procedures	intraoperative	time of the procedure
daily analgesic requirements	3 months from injection	dose of opioid
patient satisfaction	0ne month after block	0 is very dissatisfied and 10 is very satisfied

Trial Locations

Locations (1)

Yahya Wahba; 🇪🇬 Mansoura, Egypt