CT-guided Ablation of the Ganglion Impar for Pelvic Tumors: Comparethe Addition of Ketorolac or Dexamethasone
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional

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.
    

Intervention name(s): ganglion impar block
Intervention type(s): Procedure
Intervention description(s): 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%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment