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Pain, ChronicNCT03789227

CT-guided Ablation of the Ganglion Impar for Pelvic Tumors: Comparethe Addition of Ketorolac or Dexamethasone

A study testing ganglion impar block in people with Pain, Chronic, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Pain, Chronic
What is being tested?
ganglion impar block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteEgypt
Study dates
1 Jul 2018to 1 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients of either sex aged between 20 to 70 years old with pelvic tumor

Who cannot join

  • Patient's refusal.
  • Sever Hepatic and renal impairment.
  • History of allergy to the used drugs.
  • Infection at the area of injection.
  • Coagulopathies.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mansoura university , oncology mansoura university center

    Al Mansurah, Dakahlia Governorate

Other trials in Egypt

About this study

Official title: CT-guided Ethyl Alcohol Ablation of the Ganglion Impar for Pelvic Tumors: Does the Addition of Ketorolac or Dexamethasone Makes a Difference?

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

Read the 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.

Conditions
Pain, Chronic
Being tested
ganglion impar block
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ganglion impar blockProcedure or surgery

    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%.

Study groups in NCT03789227
Study groupRoleWhat they receive
Group CPlacebo comparatorganglion 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.
Receives: Procedure: ganglion impar block
Group DActive comparatorganglion 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.
Receives: Procedure: ganglion impar block
Group KActive comparatorganglion 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.
Receives: Procedure: ganglion impar block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the onset of sensory block

    occurance of analgesia

    Measured: one week

  2. patient satisfaction

    patient satisfaction score ( Jones KD, Sutton C., 2003) by questionnaire for 100

    Measured: 6 month

  3. intensity of pain

    visual analogue scale (VAS) scale from 0 to 10 o no pain 10 maximum pain 0 better 10 worst

    Measured: 6 month

  4. 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

    Measured: 6 month

Secondary outcomes (1)
  1. the time and the amount of post-procedure analgesic requirement

    the amount and timing of analgesic consumption and types of analgesics

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2018
  2. Study start1 Jul 2018
  3. Primary completion1 Jul 2019
  4. Study completion1 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03789227
Sponsor's protocol ID
- MFM-IRB ,MD ∕ 16.06.45
Status last verified
Sep 2020
First submitted
26 Dec 2018
Last updated
3 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ganglion impar block in people with Pain, Chronic, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the onset of sensory block (time frame: one week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.

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