CTRI Number	CTRI/2021/01/030607 [Registered on: 20/01/2021] Trial Registered Prospectively
Last Modified On:	16/02/2022
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Drug Surgical/Anesthesia
Study Design	Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Modification(s)	Comparision of Dexmedetomidine and Dexamethasone With levobupivacaine in transverse abdominies plane block for postoperative pain relief in patient undergoing total abdominal hystrectomies
Scientific Title of Study	Dexmedetomidine verses Dexamethasone As adjuvant to levobupivacaine in usg guided transverse abdominies plane block for postop analgesia in patient undergoing total abdominal hystrectomies
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  DrVeena Asthana  Address  Department of anaesthesia Himalayan institute of medical sciences,Swami Rama Himalayan University ,Dehradun Department of anaesthesia Himalayan institute of medical sciences,Swami Rama Himalayan University ,Dehradun Dehradun UTTARANCHAL 248140 India  Phone  09719529295   Fax     Email  veenaasthana@srhu.edu.in
Details Contact Person Scientific Query Modification(s)	Name  Jyoti Sinha  Address  Department of anaesthesia Himalayan institute of medical sciences,Swami Rama Himalayan University Dehradun Dehradun UTTARANCHAL 248140 India  Phone  9599020524   Fax     Email  jyoti18sinha@gmail.com
Details Contact Person Public Query Modification(s)	Name  DrVeena Asthana  Address  Department of anaesthesia Himalayan institute of medical sciences,Swami Rama Himalayan University Dehradun Dehradun UTTARANCHAL 248140 India  Phone     Fax     Email  veenaasthana@srhu.edu.in
Source of Monetary or Material Support	Department of Anaesthesia, Himalayan Institute of Medical Sciences, Swami Ram Nagar, Jollygrant Dehradun
Primary Sponsor	Name  Department of Anaesthesia Himalayan Institute of Medical Science   Address  Himalayan Institute of Medical Sciences, Swami Ram Nagar, Jollygrant Dehradun  Type of Sponsor  Private medical college
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Veena Asthana  Department of Anaesthesia, Himalayan Institute of Medical Sciences  Induction room ,Preop area ,operation theatre second floor -Department of Anaesthesia, Himalayan Institute of Medical Sciences, Swami Ram Nagar, Jollygrant Dehradun Dehradun   9719529195 veenaasthana@srhu.edu.in
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethical Committee  Approved
Regulatory Clearance Status from DCGI Modification(s)	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Malignant neoplasm complicating pregnancy, childbirth and the puerperium
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  Group A patient will receive TAP BLOCK with DEXAMETHASONE   group A (dexamethasone group), patient after total abdominal hysterectomy under SAB ; USG guided TAP block will be given with the anesthetic solution mixture consisted of a total volume of 40 ml levobupivacaine 0.25 % and dexamethasone 8 mg, 20 ml injected on each side.  Comparator Agent  Group B patients will receive TAP block with DEXMEDETOMIDINE   group B (dexmedetomidine group), patient after total abdominal hysterectomy under SAB the local anesthetic solution mixture consisted of a total volume of 40 ml levobupivacaine 0.25 % and dexmedetomidine 1mcg/kg body weight.  Intervention  USG guided TAP block  USG guided TAP block given after total abdominal hysterectomy under SAB for post op analgesia
Inclusion Criteria	Age From  18.00 Year(s) Age To  60.00 Year(s) Gender  Female  Details  American society of anesthesiologists (ASA) physical status grade 1 and 2. Age of 18 years and more. Patients who will be scheduled for total abdominal hysterectomies.
ExclusionCriteria	Details  Patient refusal. Body mass index (BMI) > 40. Patients with chronic pain and those using chronic analgesic medications. Coagulopathy. Allergy to the study drugs. Patients taking other medications with α-adrenergic blocking effect. Hepatic insufficiency (Liver enzymes elevated more than 2 times of normal values) Renal insufficiency ( Serum Creatinine elevated more than 2 times of normal values) Systemic infection. Infection at the site of injection.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Participant and Outcome Assessor Blinded
Primary Outcome	Outcome  TimePoints  Duration and quality of analgesia 2- Post operative analgesic consumption    Duration and quality of analgesia 2- Post operative analgesic consumption
Secondary Outcome	Outcome  TimePoints  Adverse effect or complication if any  postoperatively at 20,1,3,6,9,12,18,23
Target Sample Size	Total Sample Size="72" Sample Size from India="72"
Phase of Trial	Post Marketing Surveillance
Date of First Enrollment (India) Modification(s)	25/01/2021
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	None yet
Brief Summary Modification(s)	Total abdominal hysterectomy (TAH) operations use transverse lower abdominal incisions, which causes severe pain during the first 48h, postoperatively. The multifactorial origin of pain after abdominal hysterectomy includes incisional pain, visceral pain, and dynamic pain, especially from the abdominal wall incision.(1) Therefore, a multimodal approach to postoperative analgesia after TAH is required to abolish nociceptive transmission from the abdominal wall incision and visceral sites. There has been a preference for opioids as a part of multimodal regimen despite the fact that utilization of opioids can lead to significant adverse effects, including nausea, vomiting, sedation, and respiratory depression, thus delaying early mobilization of patients. So, the transversusabdominis plane (TAP) block appears to be an ideal approach in relieving postoperative pain in those patients, especially when used as a component of multimodal analgesia regimen.   The purpose of our study  is to compare and evaluate efficacy and safety of dexmedetomidine and dexamethasone as a local anesthetic adjuvant to levobupivacaine for postop analgesia in ultrasound guided TAP block for patients scheduled for total abdominal hysterectomies under subarachanoid block.