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Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 14:00:21 GMT)

CTRI Number CTRI/2018/12/016807 [Registered on: 31/12/2018] - Trial Registered Prospectively Last Modified On 02/04/2021 Post Graduate Thesis No Type of Trial Interventional Type of Study Surgical/Anesthesia Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study A clinical trial of comparing the effects of drugs namely Dexmedetomidine and Fentanyl when added to local anaesthetic solution used in injection around wound in in surgeries around anal canal in reducing pain after surgery Scientific Title of Comparison of analgesic efficacy of bupivacaine, bupivacaine and dexmedetomidine, and Study bupivacaine and Fentanyl in would infiltration technique in perianal surgeries: A prospective, randomized controlled study. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Gopalakrishnan K MD Trial Coordinator (multi-center study) Designation Assistant Professor Affiliation Aarupadai Veedu Medical College and Hospital Address Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital,Kirumampakkam,. 5,6 MAC avenue, Nellikuppam main road, Cuddalore District, Tamil Nadu 607 001 Pondicherry PONDICHERRY 607402 Phone 9364450310 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Haribabu V MD Query) Designation Associate Professor Affiliation Aarupadai Veedu Medical College and Hospital Address Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Pondicherry. Department of anaesthesiology, Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Pondicherry. Pondicherry PONDICHERRY 607402 India Phone 9442369647 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Haribabu V MD Designation Associate Professor Affiliation Aarupadai Veedu Medical College and Hospital Address Department of anaesthesiology, Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Pondicherry. Department of

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anaesthesiology, Aarupadai Veedu Medical College and Hospital,Kirumampakkam, Pondicherry. Pondicherry PONDICHERRY 607402 India Phone 9442369647 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Aarupadai Veedu Medical College and Hospital, Kirumampakkam, Pondicherrry 607402 Primary Sponsor Primary Sponsor Details Name GOPALAKRISHNAN K Address ASSISTANT PROFESSOR, Department of anaesthesiology, Aarupadai Veedu medical college and Hospital, Puducherry Type of Sponsor Private medical college 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 Gopalakrishnan K Aarupadai Veedu Aarupadai Veedu 9364450310 Medical College and medical college and ho Hospital, Puducherry spital,Kirumampakkam, [email protected] Puducherry 607402 Pondicherry PONDICHERRY Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Human Approved 20/12/2018 No Ethical Committee, AARUPADAI VEEDU MEDICAL COLLEGE &HOSPITAL Institutional Research Approved 30/11/2018 No Committee, Aarupadai Veedu Medical College & Hospital, Puducherry Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Anal fissure, unspecified Patients Anal fistula Patients Unspecified hemorrhoids Intervention / Type Name Details Comparator Agent Intervention Wound infiltration with local Wound infiltration with 15ml anaesthetic agent bupivacaine 0.5% bupivacaine will be done and addition of drugs only once at the end of surgery. Dexmedetomidine and Fentanyl Dexmedetomidine 1.5micg/kg , to the local anaesthetic solution Fentanyl 2micg/ml and 1ml

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saline will be added to the bupivacaine solution in Group A, Group B and Group C respectively. Comparator Agent Dexmedetomidine and Fentanyl In Group A dexmedetomidine 1.5micg/kg will be added to the local anaesthetic solution of 15ml 0.5% bupivacaine. In Group B, Fentanyl 2micg/ml will be added to the local anaesthetic solution 15ml of 0.5% bupivacaine heavy. In Group C, 1ml saline will be added to the local anaesthetic solution 15 ml of 0.5% bupivacaine. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 50.00 Year(s) Gender Both Details Patients undergoing uncomplicated perianal surgeries like haemorrhoidectomy, fissure in ano and fistula in ano, ASA I & II, Normal BMI Exclusion Criteria Exclusion Criteria Details ASA III and above, Obese, underweight subjects(BMI) , pregnant women, patients with bleeding and clotting disorders, allergic to local anesthetic agents,inadequate spinal blockade supplemented by other drugs and complicated surgeries will be excluded from the study. Method of Generating Computer generated randomization Random Sequence Method of Pre-numbered or coded identical Containers Concealment Blinding/Masking Participant and Outcome Assessor Blinded Primary Outcome Outcome Timepoints Dexmedetomidine prolongs the postoperative 12hours analgesia of wound infiltration with bupivacaine and is superior to addition of fentanyl to local local would infiltration with Secondary Outcome Outcome Timepoints Total analgesics requirement in 24 hrs is 24hrs reduced when dexmedetomidine is added to local anaesthetic solution. Addition of Fentanyl to local anaesthetic solution also reduces total analgesic requirement pain perception at daefacation on next day is 24 hours less intense. Target Sample Size Total Sample Size=75 Sample Size from India=75 Final Enrollment numbers achieved (Total)=0 Final Enrollment numbers achieved (India)=75 Phase of Trial N/A Date of First 01/01/2019 Enrollment (India)

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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 Completed Trial (India) Publication Details V Haribabu, K Gopalakrishnan, M Suresh Rajkumar, V Ezhil Rajan, R Chandrasekar. Comparison of analgesic efficacy of bupivacaine, bupivacaine with dexmedetomidine, and bupivacaine with fentanyl in local perianal infiltration technique in perianal surgeries: A prospective, randomized controlled study. MedPulse International Journal of Anesthesiology. July 2020; 15(1): 07-14 Brief Summary This study is a randomized, double blind, parallel group, controlled, multiarm trial comparing the efficacy of dexmedetomidine 1.5micg/kg and fentanyl 2micg/ml when added to the local aneasthetic solution used for would infiltration done at the end of surgery in patients undergoing uncomplicated perianal surgeries to be conducted at Aarupadai Veedu medical college and Hospital, Pondicherry. The primary outcome measures will be prolonging the postoperative analgesia duration when compared to control group. The secondary outcome measures will be reduction in total number of analgesics received over first 24 hrs and better defaecation score on the next day. Dexmedetomidine provides superior analgesia than Fentanyl.

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