Efficacy of Adding Lidocaine 10% to Phenol in Ultrasound Guided Superior Hypogastric Plexus Neurolysis in The Management of Pelvic Cancer Pain

The superior hypogastric plexus (SHP) is a complex nervous collection located at the lumbosacral region below the level of the aortic bifurcation at the level of the lower third of the fifth lumbar vertebral body and upper third of the first sacral vertebral body at the sacral promontory Neurolytic agents, such as alcohol and phenol have been used to ablate peripheral nerves to treat pain and spasticity . These agents were nonspecific for neuronal tissue and complications have been seen involving damage to surrounding soft tissue (skin, muscle, vascular) and pain on alcohol injection

Lidocaine has been demonstrated to be neurotoxic in high concentrations at 10% and can be used as a neurolytic agent with no effect on motor function, muscle state, or surrounding tissue rather than other neurolytic.

Study Overview

• Status: Not yet recruiting
• Conditions: Efficacy of Adding Lidocaine 10% to Phenol in Superior Hypogastric Plexus Neurolysis
• Intervention / Treatment: Other: Ultrasound Guided Superior Hypogastric Plexus

Detailed Description

Every Patient will be in supine Trendelenburg position, IV access in case of adverse events and for moderate sedation if needed (for patient comfort, sever anxiety or needle phobia, or history of vagal events).

The procedure will be completed under aseptic precautions. The division of abdominal aorta into common iliac arteries will be identified by using longitudinal sonography (Lumify L12-4 Linear Array Transducer 12 to 4 MHz extended operating frequency range, 34mm footprint and aperture size, and scan depth of up to 12cm. Imaging modes include 2D, color Doppler, and M-mode), and the body of the fifth (5th) Lumbar vertebra will be identified by placing the transducer transversely. A skin wheal will be raised with subcutaneous infiltration with 2% lidocaine solution nearly 3-4 cm below the umbilicus. A 15-cm Long 22-G Chiba needle will be used with out of plane technique, and the needle will be advanced under USG-guidance to reach the anterior- most point of the fifth Lumber vertebral body avoiding the vascular structures. The needle will be withdrawn nearly 1-2 mm after hitting the vertebral body to avoid injecting the drug into the periosteum. After confirming a negative aspiration of blood, known amount of neurolytic agent according to the grouping will be injected for the neurolysis of superior hypogastric plexus. The uniform spread of the drug will be confirmed under real-time sonography. Vital Sign parameters will be recorded during and after the procedure, during which patients remained fully awake

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: yahya m wahba, assist professor; Phone Number: 01211313554; Email: yahyawahba@ymail.com
• Study Contact Backup: Name: abdulrahman m nasser, doctor; Phone Number: 01064384516; Email: Abdulrahman.nasser93@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients more than 18 years old.
• Either genders.
• Cancer-related pelvic pain.
• American Society of Anesthesiologists Physical Status class I and II.
• Patients receiving opioids for pelvic cancer pain with visual analogue pain scale more than 4.
• BMI < 30.

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. allergy to the used medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: • Group P; Ultrasound guided SHPN will be done by injecting 10 ml of Phenol 10 %.	Other: Ultrasound Guided Superior Hypogastric Plexus; The division of abdominal aorta into common iliac arteries will be identified by using longitudinal sonography , and the body of the fifth (5th) Lumbar vertebra will be identified by placing the transducer transversely. A skin wheal will be raised with subcutaneous infiltration with 2% lidocaine solution nearly 3-4 cm below the umbilicus. A 15-cm Long 22-G Chiba needle will be used with out of plane technique, and the needle will be advanced under USG-guidance to reach the anterior- most point of the fifth Lumber vertebral body avoiding the vascular structures. The needle will be withdrawn nearly 1-2 mm after hitting the vertebral body to avoid injecting the drug into the periosteum. After confirming a negative aspiration of blood, known amount of neurolytic agent according to the grouping will be injected for the neurolysis of superior hypogastric plexus. The uniform spread of the drug will be confirmed under real-time sonography.
Active Comparator: • Group LP; Ultrasound guided SHPN will be done by injecting 10 ml Phenol 10 % then injecting 3 ml Lidocaine 10%.	Other: Ultrasound Guided Superior Hypogastric Plexus; The division of abdominal aorta into common iliac arteries will be identified by using longitudinal sonography , and the body of the fifth (5th) Lumbar vertebra will be identified by placing the transducer transversely. A skin wheal will be raised with subcutaneous infiltration with 2% lidocaine solution nearly 3-4 cm below the umbilicus. A 15-cm Long 22-G Chiba needle will be used with out of plane technique, and the needle will be advanced under USG-guidance to reach the anterior- most point of the fifth Lumber vertebral body avoiding the vascular structures. The needle will be withdrawn nearly 1-2 mm after hitting the vertebral body to avoid injecting the drug into the periosteum. After confirming a negative aspiration of blood, known amount of neurolytic agent according to the grouping will be injected for the neurolysis of superior hypogastric plexus. The uniform spread of the drug will be confirmed under real-time sonography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
: NRS	from 0 to 10 (0= no pain ,10 =maximum pain)	after 1 week from block
NRS	from 0 to 10 (0= no pain ,10 =maximum pain)	after 1 month from block
NRS	from 0 to 10 (0= no pain ,10 =maximum pain)	after 2 month from block
NRS	from 0 to 10 (0= no pain ,10 =maximum pain)	after 3 month from block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	using a linear scale in which 0 is unsatisfied and 1	after injection
daily analgesic requirements	the patient need of analgesia tramandin 100mg after injection	after 3 months from injection
side effect during injection	any complication during injection as hemorrhage and hypotension	during injection

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 30, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Pelvic Neoplasms; Cancer Pain
• Other Study ID Numbers: MS.21.04.1458

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No