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

NCT03789227 | Completed

• 1 other identifier: - MFM-IRB ,MD ∕ 16.06.45
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (4)

• the onset of sensory block

  occurance of analgesia

  one week

• patient satisfaction

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

  6 month

• intensity of pain

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

  6 month

• 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

  6 month

Secondary Outcomes (1)

• the time and the amount of post-procedure analgesic requirement

  6 month

Study Arms (3)

Group C

PLACEBO COMPARATOR

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.

Procedure: ganglion impar block

Group D

ACTIVE COMPARATOR

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.

Procedure: ganglion impar block

Group K

ACTIVE COMPARATOR

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.

Procedure: ganglion impar block

Interventions

ganglion impar block PROCEDURE

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%.

Group C; Group D; Group K

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university , oncology mansoura university center

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tarek M. Shams, MD

  : Professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 28, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)