search
Back to results

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

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ultrasound Guided Superior Hypogastric Plexus
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Efficacy of Adding Lidocaine 10% to Phenol in Superior Hypogastric Plexus Neurolysis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    • Group P

    • Group LP

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    : NRS
    from 0 to 10 (0= no pain ,10 =maximum pain)
    NRS
    from 0 to 10 (0= no pain ,10 =maximum pain)
    NRS
    from 0 to 10 (0= no pain ,10 =maximum pain)
    NRS
    from 0 to 10 (0= no pain ,10 =maximum pain)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 12, 2021
    Last Updated
    December 22, 2021
    Sponsor
    Mansoura University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05145972
    Brief Title
    Efficacy of Adding Lidocaine 10% to Phenol in Ultrasound Guided Superior Hypogastric Plexus Neurolysis in The Management of Pelvic Cancer Pain
    Official Title
    Efficacy of Adding Lidocaine 10% to Phenol in Ultrasound Guided Superior Hypogastric Plexus Neurolysis in The Management of Pelvic Cancer Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 30, 2021 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    October 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
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Efficacy of Adding Lidocaine 10% to Phenol in Superior Hypogastric Plexus Neurolysis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    • Group P
    Arm Type
    Active Comparator
    Arm Description
    Ultrasound guided SHPN will be done by injecting 10 ml of Phenol 10 %.
    Arm Title
    • Group LP
    Arm Type
    Active Comparator
    Arm Description
    Ultrasound guided SHPN will be done by injecting 10 ml Phenol 10 % then injecting 3 ml Lidocaine 10%.
    Intervention Type
    Other
    Intervention Name(s)
    Ultrasound Guided Superior Hypogastric Plexus
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    : NRS
    Description
    from 0 to 10 (0= no pain ,10 =maximum pain)
    Time Frame
    after 1 week from block
    Title
    NRS
    Description
    from 0 to 10 (0= no pain ,10 =maximum pain)
    Time Frame
    after 1 month from block
    Title
    NRS
    Description
    from 0 to 10 (0= no pain ,10 =maximum pain)
    Time Frame
    after 2 month from block
    Title
    NRS
    Description
    from 0 to 10 (0= no pain ,10 =maximum pain)
    Time Frame
    after 3 month from block
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction
    Description
    using a linear scale in which 0 is unsatisfied and 1
    Time Frame
    after injection
    Title
    daily analgesic requirements
    Description
    the patient need of analgesia tramandin 100mg after injection
    Time Frame
    after 3 months from injection
    Title
    side effect during injection
    Description
    any complication during injection as hemorrhage and hypotension
    Time Frame
    during injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    yahya m wahba, assist professor
    Phone
    01211313554
    Email
    yahyawahba@ymail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    abdulrahman m nasser, doctor
    Phone
    01064384516
    Email
    Abdulrahman.nasser93@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs