Effectiveness of Superior Hypogastric Plexus Neurolysis for Chronic pelvic pain in pelvic malignancies - A Randomized Controlled trial

After obtaining approval from the Post-graduate Research Monitoring committee (human studies), Institute Ethics committee (IEC) and completing Clinical trial registry India (CTRI) the study will commence. Patients with chronic pelvic pain  i.e.  pelvic malignancies with pain not being controlled on Oral Morphine Q4H , attending the Pain and Palliative Clinic after being referred from the Department of Regional Cancer Centre in JIPMER will be screened for eligibility to participate in the study. The patient will be explained regarding the procedure in detail.Those patients satisfying the inclusion criteria and are willing to participate in the study will be recruited after obtaining informed written consent. Before any intervention, the patients will undergo a detailed survey at the baseline which includes  CBC,RFT,LFT. The patients will be randomly allocated into any of the 2 groups based on a computer-generated block random number table and allocation into the groups will be concealedby the Serially Numbered Opaque Sealed Envelopes (SNOSE) technique. Two groups studied in this trial include Group I(receives Oral Morphine) Group II (receives Neurolytic Superior Hypogastric Plexus Block).8 hrs NPO status explained to patient the previous day of block,In the pain ward NPO ,premedications confirmed,18 G IV cannula secured and patient will be shifted to Operation theatre.In the operation theatre, the patient will be positioned prone on the table with a pillow between the lower abdomen and iliac crest to reduce lumbar lordosis. All ASA (American Society of Anesthesiologists) standard monitors will be attached which includes pulse oximetry, non-invasive blood pressure and electrocardiogram. Under sterile precautions, parts will be cleaned and draped. The level and the side to be blocked will be marked and confirmed again. Level identification will be done using sequential C-Arm images. At the appropriate lumbar-sacral spine level (L5-S1), local infiltration with 2%lignocaine will be given ,The tip of a 22-Gauge Chiba needle will be gradually advanced towards the anterior aspect of L5 under radiologic guidance. During the procedure, the lateral view will be obtained, and the needle will advance in the anterior direction. Optimal needle placement for injection in the location is confirmed by injecting a small volume of radio contrast media under intermittent fluoroscopic imaging. The contrast material (Iohexol Contrapaque®350, 350mg/ml) 1ml will be injected at that side to confirm that the needle is not intrathecal or intravascular,if the needle is intravascular the dye disappears ,whereas if the dye is intrathecal then there is a vertical spread of dye seen in the imaging.After ruling out the intrathecal and intravascular location of needle ,Drug with a volume of 2ml(Bupi 0.125%) will be injected in one side ,followed by the other side after confirming the location in other side followed by 8 ml 97% of Alcohol on each side. Vitals will be monitored every 1 minute for 5 minutes on the operating table after taking the patient to a supine position. Then the patient will be shifted to the pain clinic ward and all ASA standard monitoring will be done every 5 minutes for 30 minutes and then every hour for 3-4 hours. After assuring no side effects like numbness in the foot, difficulty in walking, no hemodynamic instability,the patient will be discharged home on the same day from the pain ward. In case of prolonged recovery, the patient will be transferred to the RCC ward for 1-day of observation. For both groups, following initial interventions, the patients will be advised to note down their analgesic score intheir pain diary. All patients will be evaluated for the reduction in the VAS score weekly for first month,then biweekly for the 2nd month then once in the last month through telephonic follow-up.European pain Federation Score,Adverse effects will be evaluated weekly for the first month,biweekly for the 2nd month then once in last month through telephonic communication. All patients’ will  be given Morphine 10 mg SOS on top of the analgesic treatment they are receiving and the analgesic requirements in both the groups will be noted.The Group I on Oral Morphine receiving 10mgQ4hrly,When patient’s pain is not relieved by this dosage,the dose of Morphine will be increased to15mgQ4hrly.