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

NCT ID: NCT05145972

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-30

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Efficacy of Adding Lidocaine 10% to Phenol in Superior Hypogastric Plexus Neurolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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• Group P

Ultrasound guided SHPN will be done by injecting 10 ml of Phenol 10 %.

Group Type ACTIVE_COMPARATOR

Ultrasound Guided Superior Hypogastric Plexus

Intervention Type OTHER

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.

• Group LP

Ultrasound guided SHPN will be done by injecting 10 ml Phenol 10 % then injecting 3 ml Lidocaine 10%.

Group Type ACTIVE_COMPARATOR

Ultrasound Guided Superior Hypogastric Plexus

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Nevert Adel

assist. prof. of anesthesia and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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yahya m wahba, assist professor

Role: CONTACT

Phone: 01211313554

Email: [email protected]

abdulrahman m nasser, doctor

Role: CONTACT

Phone: 01064384516

Email: [email protected]

Other Identifiers

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MS.21.04.1458

Identifier Type: -

Identifier Source: org_study_id