CTRI Trial Data

PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 18:39:00 GMT) CTRI Number CTRI/2019/03/017947 [Registered on: 06/03/2019] - Trial Registered Prospectively Last Modified On 26/02/2019 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Comparison between Buprenorphine skin patch and intravenous Paracetamol for pain relief after major reconstructive plastic surgery Scientific Title of Comparison between transdermal Buprenorphine and intravenous Paracetamol for post-operative Study analgesia after major plastic reconstructive surgery under General Anaesthesia - A randomised double blind controlled trial. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Arghya Maity Trial Coordinator (multi-center study) Designation POST GRADUATE TRAINEE Affiliation Institute of Post Graduate Medical Education and Research Address PGT Room Dept of Anaesthesiology Main Block IPGMER and SSKM Hospital Room no 524 Doctors Hostel IPGMER and SSKM Hospital Kolkata WEST BENGAL 700129 India Phone 9051207925 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Sarbari Swaika Query) Designation Associate Professor Affiliation Institute of Post Graduate Medical Education and Research Address Faculty Room Dept of Anaesthesiology Main Block IPGMER and SSKM Hospital 244 AJC Bose Road Kol 20 Kolkata WEST BENGAL 700020 India Phone 9434021722 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Arghya Maity Designation Post Graduate Trainee Affiliation Institute of Post Graduate Medical Education and Research Address PGT Room Dept of Anaesthesiology Main Block IPGMER and SSKM Hospital 244 AJC Bose Road Room no 524 Doctors Hostel IPGMER and SSKM Hospital Kolkata WEST BENGAL 700129 page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in India Phone 9051207925 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Dept of Anaesthesiology Institute of Post Graduate Medical Education and Research 244 AJC Bose Road Kolkata 700020 Primary Sponsor Primary Sponsor Details Name Arghya Maity Address Saheb bagan Bidhan pally Madhyamgram Kol 129 Type of Sponsor Other [PRINCIPAL INVESTIGATOR] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator ARGHYA MAITY Institute of Post New Plastic Surgery 9051207925 Graduate Medical Operation Theatre Education and Ronald Ross Building maityarghya9831@gma Research IPGMER and SSKM il.com Hospital 244 AJC Bose Road Kolkata 20 Kolkata WEST BENGAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? IPGMER Research Approved 27/04/2018 No Oversight Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Malignant neoplasm of external lip, unspecified Intervention / Type Name Details Comparator Agent Intervention Transdermal Buprenorphine Total Drug- 20 mg; Delivery Patch Rate- 20 mcg/hr For 1st 48 hours Post operatively. Comparator Agent Intravenous Paracetamol 15 mg/kg iv infusion over 15 min for 1st 48 hrs post operatively. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details Patients belonging to either sex of age 18-65 years with ASA physical status I and II scheduled to undergo elective major plastic reconstructive surgery under GeneralAnaesthesia.<br/> <br/> Exclusion Criteria Exclusion Criteria Details a) Patient refusal to give consent b) Patients with evidence of pre-existing pain in nonsurgical site (poly page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in trauma, any fracture, neurological pain etc) c) Patients with significant cardiac, respiratory, hepatic or renal disorders or any other uncontrolled systemic illness d) Obesity(BMI>35) e) History of delirium tremens f) Pregnancy, Lactation g) History of allergy to Anaesthetic drugs and analgesics (Paracetamol, Diclofenac, Tramadol) and opioid addiction h) Those receiving long term analgesic therapy i) Infection and dermatitis at the site of patch application j) History of seizures Method of Generating Random Number Table Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Participant and Investigator Blinded Primary Outcome Outcome Timepoints 1. Assessment of Postoperative Pain by Visual Immediate Post operative period, at 2 hrs Analogue Scale postoperatively, at 4 hrs postoperatively, at 12 2. Need of Rescue Analgesic hrs 3. Degree of Postoperative Sedation by Ramsay Sedation Scale Secondary Outcome Outcome Timepoints Haemodynamic changes ( Heart Rate, Non Immediate Post operative period, at 2 hrs Invasive Blood Pressure - SBP/DBP/MAP , postoperatively, at 4 hrs postoperatively, at 12 SpO2, ECG) hrs postoperatively, at 24 hrs postoperatively, at 36 hrs postoperatively, at 48 hrs postoperatively. Target Sample Size Total Sample Size=40 Sample Size from India=40 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 11/03/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details None yet Brief Summary After approval of the Institutional Ethics Committee, a prospective, randomised, double blind, controlled trial comparing the effects of Transdermal Buprenorphine with Intravenous Paracetamol for assessment of post operative analgesia, in terms of efficacy and safety, will be carried out on patients of ASA physical status I and II, scheduled to undergo elective major plastic reconstructive surgery under general anaesthesia from May 2018 to April 2019, in NPS OT and Main Surgical OT of IPGMER & SSKM Hospital. page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in The patients will be divided into two groups by using a randomisation table. In Group B, Buprenorphine via Transdermal route (20mcg/hr; 20mg.) and in Group P, Paracetamol via Intravenous route(15mg/ kg. 6 hrly), will be given. The parameters which will be compared are – 1) assessment of post operative analgesia, 2) need of any resque analgesic, 3) degree of sedation, 4) post operative hemodynamic changes and 5) any adverse outcome. page 4 / 4 Powered by TCPDF (www.tcpdf.org).

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