Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain
Primary Purpose
Pain Cancer
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Group US-guided
Group fluoroscopy-guided
Sponsored by
About this trial
This is an interventional treatment trial for Pain Cancer
Eligibility Criteria
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.
Sites / Locations
- Yahya WahbaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group US-guided
- Group fluoroscopy-guided
Arm Description
will receive superior hypogastric plexus neurolysis by the US-guided anterior approach
will receive superior hypogastric plexus neurolysis by the fluoroscopy-guided anterior approach
Outcomes
Primary Outcome Measures
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.
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
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
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
Secondary Outcome Measures
time of the procedures
time of the procedure
daily analgesic requirements
dose of opioid
patient satisfaction
0 is very dissatisfied and 10 is very satisfied
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05299047
Brief Title
Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain
Official Title
Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group US-guided
Arm Type
Active Comparator
Arm Description
will receive superior hypogastric plexus neurolysis by the US-guided anterior approach
Arm Title
- Group fluoroscopy-guided
Arm Type
Active Comparator
Arm Description
will receive superior hypogastric plexus neurolysis by the fluoroscopy-guided anterior approach
Intervention Type
Other
Intervention Name(s)
Group US-guided
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group fluoroscopy-guided
Intervention Description
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.
Primary Outcome Measure Information:
Title
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
Description
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.
Time Frame
0ne hour before block
Title
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
Description
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
Time Frame
1 month from block
Title
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
Description
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
Time Frame
2 months from block
Title
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
Description
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
Time Frame
3 months from block
Secondary Outcome Measure Information:
Title
time of the procedures
Description
time of the procedure
Time Frame
intraoperative
Title
daily analgesic requirements
Description
dose of opioid
Time Frame
3 months from injection
Title
patient satisfaction
Description
0 is very dissatisfied and 10 is very satisfied
Time Frame
0ne month after block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yahya m wahba
Phone
01211313554
Email
yahyawahba@ymail.com
First Name & Middle Initial & Last Name or Official Title & Degree
abdulrahman nasser
Phone
01064384516
Email
Abdulrahman.nasser93@gmail.com
Facility Information:
Facility Name
Yahya Wahba
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yahya wahba, assist prof.
Phone
01211313554
Email
yahyawahba@gmail.com
First Name & Middle Initial & Last Name & Degree
adel abdel ghaffar, pof.
Phone
01210101001
Email
adelghaffar49@gmail.com
First Name & Middle Initial & Last Name & Degree
nevert a abdel ghaffar, assist prof
First Name & Middle Initial & Last Name & Degree
Tamer E abdallah, assist prof
12. IPD Sharing Statement
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Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain
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