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

Pain Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299047
• Other study ID #: R.22.01.1598
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2022
• Source: Mansoura University
• Contact: yahya m wahba
• Phone: 01211313554
• Email: yahyawahba[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: September 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain Cancer
• Pelvic Pain

Intervention

Other:
• Group US-guided
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.
• Group fluoroscopy-guided
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.

Locations

Country	Name	City	State
Egypt	Yahya Wahba	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	time of the procedures	time of the procedure	intraoperative
Secondary	daily analgesic requirements	dose of opioid	3 months from injection
Secondary	patient satisfaction	0 is very dissatisfied and 10 is very satisfied	0ne month after block