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1 Clinical Trial Details (PDF Generation Date :- Sun, 17 Mar :13:06 GMT) CTRI Number Last Modified On 09/05/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/05/ [Registered on: 22/05/2014] - Trial Registered Retrospectively Yes Interventional Drug Surgical/Anesthesia Randomized, Parallel Group, Active Controlled Trial Comparison of two drugs given in nerve block given to relieve pain after arthroscopic surgeries Comparison of clonidine versus fentanyl as an adjuvant to local anaesthetic in femoro-sciatic nerve block for post operative analgesis after anterior cruciate ligament repair Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator Dr Nidhi Panda Additional Professor PGIMER, Phone Department of Anaesthesia and Intensive Care, PGIMER, nidhibp@gmail.com Details Contact Person (Scientific Query) Dr Usha Kumari Chaudhary Senior resident Phone Department of Anaesthesia,Dr RPGMC, Tanda, kangra, HP Department of Anaesthesia Dr RP Government medical College Tanda kangra Himachal Pradesh Kangra HIMACHAL PRADESH chaudhary.ushaarvind@gmail.com Details Contact Person (Public Query) Dr Nidhi Panda Additional Professor PGIMER, Department of Anaesthesia and Intensive Care, PGIMER, page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Phone > Director, PGIMER Type of Sponsor List of Countries of Principal Investigator nidhibp@gmail.com Source of Monetary or Material Support Primary Sponsor Details Director PGIMER The Director PGIMER Sector 12 Research institution and hospital of Site Site Phone// Dr Nidhi Panda PGIMER Department of Anaesthesia and Intensive Care PGIMER nidhibp@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? PGIMER Approved 05/02/2010 No Status Not Applicable Health Type Patients Date No Date Specified Condition knee joint pain for anterior cruciate ligament repair Type Details Comparator Agent Fentanyl group 40ml of 0.25% bupivacaine with fentanyl 1mcg/kg in femoral and sciatic nerve block, 20ml in each, only once Comparator Agent Clonidine group 40ml of 0.25% bupivacaine with clonidine 1mcg/kg through femoro sciatic nerve block, 20ml in each femoral and sciatic block, only once Comparator Agent control group 40ml of 0.25% bupivacaine through femoro sciatic nerve block, 20ml in each femoral and sciatic block, only once Intervention Femoro SCiatic nerve block Femoral and sciatic nerve block given in patients undergoing anterior cruciate ligament repair, once during intraoperative period Age From Year(s) Inclusion Criteria page 2 / 5

3 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Age To Gender Details Year(s) Both ASA grade 1 or 2 patients with knee joint pain for anterior cruciate ligament repair Exclusion Criteria Details Patients with BMI more than 30 local infections anatomic deformities coagulation disorders allergy to local anaesthetics fentanyl or clonidine unwilling to participate Computer generated randomization Sequentially numbered, sealed, opaque envelopes Participant and Outcome Assessor Blinded Primary Outcome Outcome Timepoints pain score, duration of analgesia, total amount of rescue analgesic, duration of motor and sensory blockade 0, 1, 2, 4, 8, 12, 18 and 24 hours Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Sedation score, hemodynamics Total Sample Size=60 Sample Size from =60 N/A 08/02/2010 No Date Specified Years=2 Months=0 Days=0 Not Applicable Completed Not published yet Summary 0,1,2,4,8,12,18 and 24 hours Background Use of adjuvants with local anaesthetic drugs in peripheral nerve blocks is known to improve the quality and duration of analgesia but no comparison page 3 / 5

4 has been done previously between clonidine and fentanyl as adjuvants to bupivacaine. We compared the effect of addition of clonidine (1mcg/kg) or fentanyl (1mcg/kg) to bupivacaine (0.25%) in femoro sciatic nerve block for patients undergoing anterior cruciate ligament reconstruction on the duration of analgesia and total requirement of rescue analgesic. Methods Sixty patients, 18-60years of age were randomly allocated to three groups. After receiving 3ml of bupivacaine (0.5%) in subarachnoid block, patients in Group 1 (control group) received 40 ml of 0.25% isobaric bupivacaine (20 ml in femoral block and sciatic block each), Group II (fentanyl group) received 40 ml of 0.25% isobaric bupivacaine with fentanyl (1mcg/kg) and Group III (clonidine group) received 40 ml of 0.25% isobaric bupivacaine with clonidine(1mcg/kg). The intra and post operative haemodynamics, pain score and sedation score were recorded along with duration of analgesia, sensory and motor block at 0,1,2,4, 8,12,18 and 24 hours. Results The patients in clonidine group had longer duration of analgesia (10.06 ± 3.62 hrs) as compared to fentanyl (7.94 ±3.62 hrs) and control group (4.59±1.20 hrs). Total amount of rescue analgesic requirement was least in clonidine group (71.25±16.77mg) as compared to fentanyl (86.25±36.71mg) and control group (161.20±50.34 mg). The number of page 4 / 5

5 Powered by TCPDF ( rescue analgesic bolus usage was at 9 hours in control group as compared to clonidine and fentanyl group in which it was at 24hour and 12 hour, respectively. There were no clinically significant side effects observed with the use of any of the adjuvants. Conclusion We concluded that use of clonidine (1mcg/kg) as adjuvant to bupivacaine (0.25%) in FSNB prolongs the duration of analgesia thereby, lowering the amount of rescue analgesic requirement postoperatively better than use of fentanyl (1mcg/kg) as adjuvant, without any untoward side effect. page 5 / 5