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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 20:51:58 GMT) CTRI Number CTRI/2019/04/018825 [Registered on: 29/04/2019] - Trial Registered Prospectively Last Modified On 24/04/2019 Post Graduate Thesis No Type of Trial Interventional Type of Study Surgical/Anesthesia Study Design Randomized, Parallel Group Trial Public Title of Study To compare efficacy of two different abdominal plane blocks for providing postoperative pain relief after inguinal hernia repair surgeries. Scientific Title of Comparing the postoperative analgesic efficacy of Quadratus Lumborum block vs Transverse Study Abdominis plane block in patients undergoing elective unilateral open inguinal hernia repair surgeries:a randomised controlled trial Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Arun S Trial Coordinator (multi-center study) Designation Assistant professor Affiliation Dr.somervell memorial C.S.I medical college Address Dr.somervell memorial C.S.I medical college, Karakonam. Thiruvananthapuram. India. Pin-695504 Thiruvananthapuram KERALA Karakonam. Thiruvananthapuram. KERALA. India Pin-695504 Thiruvananthapuram KERALA 695504 India Phone 9894555023 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Arun S Query) Designation Assistant professor Affiliation Dr.somervell memorial C.S.I medical college Address Dr.somervell memorial C.S.I medical college, Karakonam. Thiruvananthapuram KERALA India Pin-695504 Karakonam. Thiruvananthapuram KERALA. India Pin-695504 Thiruvananthapuram KERALA 695504 India Phone 9894555023 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Arun S Designation Assistant professor Affiliation Dr.somervell memorial C.S.I medical college Address Dr.somervell memorial C.S.I medical college, Karakonam. Thiruvananthapuram. KERALA. India Pin-695504 Karakonam. Thiruvananthapuram KERALA India Pin-695504 page 1 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in Thiruvananthapuram KERALA 695504 India Phone 9894555023 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Department of anesthesiology. Dr.Somervell memorial C.S.I Medical College and hospital.karakonam. THIRUVANANTHAPURAM Primary Sponsor Primary Sponsor Details Name DrSMCSImedical college Address Dr.S.M.C.S.I.medical college, Karakonam, Thiruvananthapuram India. Pin-695504 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 ARUN S Dr.sOMERVELL van knowles 9894555023 Memorial C.S.I Medical complex,second college and hospital floor,room number 228, [email protected] Karakonam m Thiruvananthapuram India Pin-695504 KERALA Thiruvananthapuram KERALA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institution human ethics Approved 25/03/2019 No committee,Dr.S.M.C.S.I medical college Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Unilateral inguinal hernia, without obstruction or gangrene Intervention / Type Name Details Comparator Agent Intervention Quadratus lumborum block quadratus lumborum block in which local anesthetic (20ml of 0.25% ropivacaine) will be injected under usg guidance between quadratus lumborum block and psoas major muscles. Comparator Agent Transverse Abdominis plane local anesthetic (20 ml of 0.25% Block ropivacaine) injected in between internal oblique and transverse abdominis muscle of abdomen under USG guidance. page 2 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in Inclusion Criteria Inclusion Criteria Age From 20.00 Year(s) Age To 60.00 Year(s) Gender Both Details ASA 1 OR 2<br/> Elective hernia repair<br/> BMI between 20-35 kg/sqm Exclusion Criteria Exclusion Criteria Details Patient refusal Allergic to local anesthetics Coagulation abnormality Psychiatric illness Local skin infection BMI >35kg/sqm ASA 4 or greater patients with recurrent or complicated hernia Method of Generating Coin toss, Lottery, toss of dice, shuffling cards etc Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints Duration of postoperative analgesia. Duration of postoperative analgesia. Secondary Outcome Outcome Timepoints Postoperative Numerical rating Pain Monitored for 24 hours after block performance scores(NRS) at 0,1,2,3,4,5,6,8,12,24 hours and the mean postoperative NRS score. Target Sample Size Total Sample Size=80 Sample Size from India=80 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 01/05/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details none yet Brief Summary We will compare the quadratus lumborum (QL) block and transversus abdominis plane (TAP) block in unilateral open inguinal hernia repair surgeries.TAP block mainly anaesthesizes the somatic nerves supplying the anterior abdominal wall.The QL block spread to paravertebral space and can be useful for both somatic and visceral pain. so we hypothesize that QL block is better than TAP block in inguinal hernia repair surgeries.we will compare the analgesic efficacy by estimating the duration of analgesia in two groups .In case of pain the patients will be supplemented with inj.tramadol. page 3 / 3 Powered by TCPDF (www.tcpdf.org).
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