Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain
1 other identifier
interventional
96
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 28, 2022
CompletedFirst Posted
Study publicly available on registry
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedAugust 16, 2022
August 1, 2022
4 months
February 28, 2022
August 13, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
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.
0ne hour before block
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
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
1 month from block
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
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
2 months from block
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
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
3 months from block
Secondary Outcomes (3)
time of the procedures
intraoperative
daily analgesic requirements
3 months from injection
patient satisfaction
0ne month after block
Study Arms (2)
Group US-guided
ACTIVE COMPARATORwill receive superior hypogastric plexus neurolysis by the US-guided anterior approach
- Group fluoroscopy-guided
ACTIVE COMPARATORwill receive superior hypogastric plexus neurolysis by the fluoroscopy-guided anterior approach
Interventions
An ultrasound system with a 5-2 MHz curved transducer will be used. The division of the abdominal aorta into the common iliac arteries was located using oblique sonography. Then, the transducer will image the body of the fifth lumbar vertebra, at which level bilateral common iliac vessels will be seen leaving a space in the midline. a 20 cm long, 22 gauge Chiba needle will be introduced into the hypogastrium, with out-of-plane technique to access the fifth lumbar vertebral body at its anterior-most point, so that injected drug spreads equally bilaterally along the anterior curvature of the fifth lumbar vertebral body.Suction was applied to the needle to confirm that it was not within a vessel and 10 ml of 50% ethanol will be injected for neurolysis.
The patient will be placed in the supine position. The L5-S1 inter-discal space was identified under fluoroscopy.After providing local cutaneous and subcutaneous anesthesia with 2% Lignocaine solution nearly 3-4 cm below the umbilicus, a 20 cm long, 22 gauges Chiba needle is advanced to the anterior portion of the 5th vertebral body under ongoing fluoroscopic guidance. Once bony resistance is reached, gently inject 2-5 ml contrast which typical reveals a characteristic triangular blob of contrast with no vascular opacification.Before injection the needle is aspirated to confirm there is no blood. A preliminary test dose of about 3 cc of 0.5% bupivacaine is then injected. If there is no change in heart rate or neurological status, rest of the 20 cc phenol 10% is injected slowly with intermittent aspiration.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yahya Wahba
Al Mansurah, Egypt
Related Publications (1)
Abdelghaffar NA, Farahat TE. Fluoroscopic anterior approach versus ultrasound guided superior hypogastric plexus neurolysis in cancer pelvic pain: a randomized controlled study. BMC Anesthesiol. 2022 Dec 27;22(1):403. doi: 10.1186/s12871-022-01948-3.
PMID: 36575390DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assist. prof. of anesthesia and pain management
Study Record Dates
First Submitted
February 28, 2022
First Posted
March 28, 2022
Study Start
January 1, 2022
Primary Completion
May 1, 2022
Study Completion
September 1, 2022
Last Updated
August 16, 2022
Record last verified: 2022-08