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
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
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
NCT ID
NCT05145972
First Posted
November 12, 2021
Last Updated
December 22, 2021
Sponsor
Mansoura University
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
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