A RANDOMISED CONTROLLED TRIAL TO STUDY THE EFFECT OF PREOPERATIVE SYSTEMIC MAGNESIUMSULFATE INFUSION ON POST OPERATIVE PAIN AND POST OPERATIVE ILEUS FOLLOWING NON LAPAROSCOPIC MAJOR ABDOMINAL SURGERIES

Post operative pain management and control may help in early mobilisation and recovery of the patient. Pain during surgery is managed intraoperatively by General anaesthesia or spinal anaesthesia or regional anaesthesia. Post operative pain is managed either by Epidural top up or by IV/IM analgesics. Magnesium is the 4th most common cation in the body and is called the nature’s physiological calcium channel blocker. It interferes with calcium channels and NMDA receptors play an important role in pain relief. Activation of NMDA cause calcium and sodium influx into cell and with an e lux of potassium and initiation of central sensitization of pain. NMDA receptor antagonist plays an important role in central sensation of pain by preventing it. NMDA receptor signalling may be important factor determining the duration and intensity of postoperative pain. Hypomagnesemia is one of the known causes of Ileus. There have been several studies that investigate the e ect of pre and intra op magnesium sulphate infusion and its role in reducing post op analgesia required, where as there is a lack of studies investigating its e ect on post operative ileus. METHODOLOGY: Study design – Prospective Randomised Control trail Sample size-50 Sampling technique- lottery technique SUBJECT SELECTION: INCLUSIVE CRITERIA: This is a RCT study in department of general surgery, Chettinad health and research institute, Kelambakkam, Tamilnadu in patients undergoing major abdominal surgeries.Patients of age >18 and <60 years. Patients undergoing open abdominal surgeries.Patients who received ASA 1, 2 in Pre anaesthetic check.Patients with normal Serum Magnesium levels. Patients who consented to be included in the study. EXCLUSIVE CRITERIA: Patients of age <18 and >60 years. Patients with Liver failure, Renal failure, Heart block, Arrythmia, EF<45%, Pregnancy, Neurological disorders, Hypersensitivity Patients with serum magnesium above normal. Patients with Blood glucose >200mg/dl on the day of surgery. Patient on Calcium channel blockers. Patients undergoing laparoscopic abdominal surgeries Those who don’t give consent to be included in the study. STUDY PROCEDURE: All the patients who fit the inclusion criteria will be observed and following data will be collected 1. Routine blood investigations 2. Pre operative serum magnesium levels 3. Comparative study done , Study group will receive 40mg/kg magnesium sulfate in 100ml ns 30 minutes before induction as IV infusion and using equal volume of Normal saline in control group Postoperative pain on 1st, 2nd ,4th , 12th , 24th postoperative hour as per visual analogue pain scale. Postoperative Time of 1st appearance of bowel sounds noted. Postoperative Time of 1st passage of flatus noted. STATISTICAL METHODS: All collected data will be evaluated using appropriate statistical method SOURCES OF FUNDING AND FINANCIAL REQUIREMENTS FOR THE PROPOSAL: Expenses related to pre- operative, intra-operative and post-operative phase shall be met by the patient. For economically weaker section of patients, a request for concession shall be referred to hospital’s MS o ice with relevant documents (Below poverty line card, Aadhar card) to get permissible and applicable concessional treatment. ETHICAL ISSUES INVOLVED AND MEASURES TO BE TAKEN TO PREVENT ETHICAL ISSUES: Approval of CHRI ethical committee will be obtained. All participants will be informed regarding the purpose of study, pros and cons of the infusio, complication associated with the procedure and confidentiality of research study in local language. An informed consent will also be taken from the study participants who are willing to participate in the study. Consent also shall be taken to reproduce his or her investigations, films clinical evaluation data for publishing in index journals without compromising his or her confidentiality. REFERENCE: Bathina AV, Peetani RK, Vaitla VT. A prospective randomized controlled trial to study the e ect of preoperative and intraoperative magnesium over postoperative ileus and postoperative pain in major non–laparoscopic abdominal surgeries. International Surgery Journal. 2019 Aug 28;6(9):3182-7