CT-guided Ablation of the Ganglion Impar for Pelvic Tumors: Comparethe Addition of Ketorolac or Dexamethasone
Primary Purpose
Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ganglion impar block
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic
Eligibility Criteria
Inclusion Criteria:
- patients of either sex aged between 20 to 70 years old with pelvic tumor
Exclusion Criteria:
- Patient's refusal.
- Sever Hepatic and renal impairment.
- History of allergy to the used drugs.
- Infection at the area of injection.
- Coagulopathies.
Sites / Locations
- Mansoura university , oncology mansoura university center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Group C
Group D
Group K
Arm Description
ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 4 ml saline in a total volume 12 ml.
ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 8 mg dexamethasone with 4 ml saline in a total volume 12 ml.
ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 15 mg ketorolac with 4 ml saline in total volume 12 ml.
Outcomes
Primary Outcome Measures
the onset of sensory block
occurance of analgesia
patient satisfaction
patient satisfaction score ( Jones KD, Sutton C., 2003) by questionnaire for 100
intensity of pain
visual analogue scale (VAS) scale from 0 to 10 o no pain 10 maximum pain 0 better 10 worst
incidence of early complications
Early complications will be recorded including allergy, bleeding, hematoma, infection, perforation of the rectum and/or bowel, bladder incontinence and nerve root injury. The cauda equine syndrome is another potential complication
Secondary Outcome Measures
the time and the amount of post-procedure analgesic requirement
the amount and timing of analgesic consumption and types of analgesics
Full Information
NCT ID
NCT03789227
First Posted
December 26, 2018
Last Updated
September 2, 2020
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT03789227
Brief Title
CT-guided Ablation of the Ganglion Impar for Pelvic Tumors: Comparethe Addition of Ketorolac or Dexamethasone
Official Title
CT-guided Ethyl Alcohol Ablation of the Ganglion Impar for Pelvic Tumors: Does the Addition of Ketorolac or Dexamethasone Makes a Difference?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
this study investigator will resaearsh about the efficacy of addition of ketorlac or dexamethasone to alcohol in ablation of ganglion impar in pelvic tumour to asses thier efficacy in increasing the intensity or the duration of the block
Detailed Description
The aim of this study is to compare the effect of administration of ketorolac versus dexamethasone on CT guided ganglion impar block with ethyl alcohol in patients with pelvic tumor.
The primary outcome will be the onset of sensory block, patient satisfaction measured by patient satisfaction score ( Jones KD, Sutton C., 2003), intensity of pain measured by a linear visual analogue scale (VAS) (Bourdel, N. et al., 2014) and incidence of early complications and side effects.
The secondary outcome will include the duration of sensory block, the time and the amount of post-procedure analgesic requirement, itching and any associated complications.
We hypothesized that CT guided ganglion impar block will be a good choice in pain reduction in patients with chronic pelvic pain. Pain reduction will be greater in dexamethasone and ketorolac group compared to alcohol group.Preinterventional assessment includes general, pain specific history taking (location, quality, intensity, relieving and provoking incidences) and pain in specific physical examination (inspection and palpation) will be carried out. Type of pelvic tumor, investigation related to tumor, previous operations, chemotherapy, basic demographic variables including age, sex and body mass index will be recorded. Routine investigations include bleeding profiles (bleeding time, clotting time, INR), blood picture, liver and kidney function tests will be carried out. A linear visual analogue scale (VAS) on a scale of 0-10 mm (where 0 for no pain and 10 for worst pain) will be explained to each patient. Written informed consent will be obtained, detailed information on risks and complications will be provided.The vital signs (heart rate, blood pressure, spo2) will be recorded. After establishing an access to peripheral venous line, 500 ml normal saline will be given to the patient, the patient will be in the prone position with a pillow under the abdomen to allow flexion of the lumbo-sacral spine with internal rotation of the lower extremities.All patients will be asked to empty the bladder and rectum before the start of the procedure to facilitate needle placement and avoid inadvertent injection. The pre-injection planning images will be obtained using CT with 2 mm axial section thickness. A needle localizer will be placed on the skin surface to identify and mark the sacro-coccygeal disc.
Sterilization of The patient's sacral and gluteal areas will be provided with povidone iodine antiseptic solution and this area was circumferentially draped with sterile towels. Under aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle either in midline or paramedian approach. After identifying the ganglion impar, usually at the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to patient position and operative condition. In the midline approach the sacro-coccygeal disc is identified and needle will be introduced perpendicular through the disc and just encroaching upon presacro-coccygeal space. The patient will be rescanned to confirm the position of the tip of the spinal needle at the anterior aspect of the sacro-coccygeal junction in the retroperitoneal space (Datir A and Connell D., 2010).
Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95% ± 8 mg dexamethasone or (15 mg ketorolac) will be slowly injected for therapeutic chemical neurolysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 4 ml saline in a total volume 12 ml.
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 8 mg dexamethasone with 4 ml saline in a total volume 12 ml.
Arm Title
Group K
Arm Type
Active Comparator
Arm Description
ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 15 mg ketorolac with 4 ml saline in total volume 12 ml.
Intervention Type
Procedure
Intervention Name(s)
ganglion impar block
Intervention Description
the patient will be in the prone position with a pillow under the abdomen The pre-injection planning images will be obtained using CT with 2 mm axial section thickness. Under aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle either in midline or paramedian approach. After identifying the ganglion impar, usually at the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to patient position and operative condition. In the midline approach the sacro-coccygeal disc is identified and needle will be introduced perpendicular through the disc and just encroaching upon presacro-coccygeal space. Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95%.
Primary Outcome Measure Information:
Title
the onset of sensory block
Description
occurance of analgesia
Time Frame
one week
Title
patient satisfaction
Description
patient satisfaction score ( Jones KD, Sutton C., 2003) by questionnaire for 100
Time Frame
6 month
Title
intensity of pain
Description
visual analogue scale (VAS) scale from 0 to 10 o no pain 10 maximum pain 0 better 10 worst
Time Frame
6 month
Title
incidence of early complications
Description
Early complications will be recorded including allergy, bleeding, hematoma, infection, perforation of the rectum and/or bowel, bladder incontinence and nerve root injury. The cauda equine syndrome is another potential complication
Time Frame
6 month
Secondary Outcome Measure Information:
Title
the time and the amount of post-procedure analgesic requirement
Description
the amount and timing of analgesic consumption and types of analgesics
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients of either sex aged between 20 to 70 years old with pelvic tumor
Exclusion Criteria:
Patient's refusal.
Sever Hepatic and renal impairment.
History of allergy to the used drugs.
Infection at the area of injection.
Coagulopathies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek M. Shams, MD
Organizational Affiliation
: Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura university , oncology mansoura university center
City
Mansourah
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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CT-guided Ablation of the Ganglion Impar for Pelvic Tumors: Comparethe Addition of Ketorolac or Dexamethasone
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