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CTRI Number  CTRI/2024/01/062115 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 27/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Dexmedetomidine versus Dexamethasone as an adjuvant to 0.25% Ropivacaine in Ultrasound guided bilateral Rectus Sheath. 
Scientific Title of Study   Dexmedetomidine versus Dexamethasone as an adjuvant to Ropivacaine in USG- guided Rectus Sheath Block for post-op analgesia in patients undergoing exploratory laparotomy.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akshi Manoher 
Designation  Junior Resident 
Affiliation  himalayan institute of medical sciences 
Address  Dept of Anesthesiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Ram Nagar, Jollygrant, Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  9609555295  
Fax    
Email  akshimanohar1178@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhimanyu Singh Pokhriyal 
Designation  Associate Professor  
Affiliation  himalayan instiute of medical sciences 
Address  Dept. of Anesthesiology, Himalayan Institute of Medical Sciences,Swami Rama Himalayan University, Swami Ram Nagar, Jollygrant, Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  9536997962  
Fax    
Email  Pokhriyal.abhimanyu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhimanyu Singh Pokhriyal 
Designation  Associate Professor  
Affiliation  himalayan instiute of medical sciences 
Address  Dept of Anesthesiology , Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Ram Nagar, Jollygrant, Dehradun


UTTARANCHAL
248140
India 
Phone  9536997962  
Fax    
Email  Pokhriyal.abhimanyu@gmail.com  
 
Source of Monetary or Material Support  
Himalayan Institute of medical science, Swami Rama Himalayan University 
 
Primary Sponsor  
Name  Himalayan Institute of Medical Sciences 
Address  Swami Rama Himalayan University, 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  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshi Manoher  Himalayan Institute of Medical Sciences  Dept of Anesthesiology, Himalayan Institute of Medical Sciences,Swami Rama Himalayan University, Swami Ram Nagar, Jollygrant, Dehradun
Dehradun
UTTARANCHAL 
9609555295

akshimanohar1178@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Himalayan Institute of Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine versus Dexamethasone as an adjuvant to Ropivacaine in USG- guided Rectus Sheath Block for post-op analgesia in patients undergoing exploratory laparotomy  Group 2 will receive Inj Dexmedetomidine 1mcg/kg with Inj Ropivacaine 0.25% . The USG- guided Rectus Sheath Block will be given before extubation bilaterally. Patients will, then, be transferred to the post-anesthesia care unit and observed postoperatively. In PACU, patient will be attached to intravenous PCA pump loaded with Tramadol . Bolus of 20 mg with lock out time of 10 mins will be set. The intensity of pain will be assessed using VAS score system at 0mins, 10mins, 20 mins and 30mins, and then, at 4 th hour, 8 th hour, 12 th hour, 16 th hour, 20 th hour and 24 th hours by the anesthesiologist (independent observer). Further, Sedation score (Ramsay Sedation Score), side effects like– nausea, vomiting, and pruritus (categorical scale) will also be noted.In statistical analysis, the primary outcome will be measured as the time of first rescue analgesia .  
Intervention  Dexmedetomidine versus Dexamethasone as an adjuvant to Ropivacaine in USG- guided Rectus Sheath Block for post-op analgesia in patients undergoing exploratory laparotomy  Group 3 will recieve only Inj Ropivacaine 0.25%. The USG- guided Rectus Sheath Block will be given before extubation bilaterally. Patients will, then, be transferred to the post-anesthesia care unit and observed postoperatively. In PACU, patient will be attached to intravenous PCA pump loaded with Tramadol . Bolus of 20 mg with lock out time of 10 mins will be set. The intensity of pain will be assessed using VAS score system at 0mins, 10mins, 20 mins and 30mins, and then, at 4 th hour, 8 th hour, 12 th hour, 16 th hour, 20 th hour and 24 th hours by the anesthesiologist (independent observer). Further, Sedation score (Ramsay Sedation Score), side effects like– nausea, vomiting, and pruritus (categorical scale) will also be noted.In statistical analysis, the primary outcome will be measured as the time of first rescue analgesia . 
Comparator Agent  Dexmedetomidine versus Dexamethasone as an adjuvant to Ropivacaine in USG- guided Rectus Sheath Block for post-op analgesia in patients undergoing exploratory laparotomy  Patients undergoing exploratory laparotomy with midline incision will be divided into 3 groups. Group 1 will receive Inj Dexamethane 8mg with inj Ropivacaine 0.25% . The USG- guided Rectus Sheath Block will be given before extubation bilaterally. Patients will, then, be transferred to the post-anesthesia care unit and observed postoperatively. In PACU, patient will be attached to intravenous PCA pump loaded with Tramadol . Bolus of 20 mg with lock out time of 10 mins will be set. The intensity of pain will be assessed using VAS score system at 0mins, 10mins, 20 mins and 30mins, and then, at 4 th hour, 8 th hour, 12 th hour, 16 th hour, 20 th hour and 24 th hours by the anesthesiologist (independent observer). Further, Sedation score (Ramsay Sedation Score), side effects like– nausea, vomiting, and pruritus (categorical scale) will also be noted.In statistical analysis, the primary outcome will be measured as the time of first rescue analgesia .  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 18-60 years.
Physical status ASA I and ASA II
Undergoing elective midline abdominal laparotomy under General
Anesthesia 
 
ExclusionCriteria 
Details  Patients aged less than 18 years or more than 60 years
Physical status ASA III and ASA IV
Allergic to any medication to be used in this study
Bleeding diathesis
Active skin infection over the area Of injection
Patients who shall not give consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
the primary outcome will be measured as the time of first rescue analgesic used which will be the time duration of analgesia produced by the block within 24 hours.  the primary outcome will be measured as the time of first rescue analgesic used which will be the time duration of analgesia produced by the block within 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Total opioid consumption over 24 hours.
2. Rates of side effect (nausea, vomiting, pruritis) if any within the first 24 hours.
3.Patient satisfaction utilizing a Likert scale questionnaire on a post-operative day –
4.Adverse drug reaction caused by drugs used if any
 
0mins, 10mins, 20 mins and 30mins, and then, at 4th hour, 8th hour, 12th hour, 16th hour, 20th hour and 24th hours  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   Phase 1 
Date of First Enrollment (India)   08/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study will be performed on adult patients, between the age group of 18-60 years) who will undergo exploratory laparotomy after obtaining the approval from the local ethical committee and scientific institutional review board. Patients will be assessed based on a multitude of factors : history ,physical examination , available investigations and as per the inclusion and exclusion criteria, they will be randomly allocated to receive either a mixture of Ropivacaine and dexamethasone (group A) or a mixture of Ropivacaine and dexmedetomidine (group B) or just Ropivacaine. (Group C).Informed written consent will be signed by each patient.

All eligible patients will be kept fasting for 6 hours for solid food and 2 hours for clear fluids prior to surgery. All the patients will be given tablet alprazolam 0.25 mg and tablet ranitidine 150 mg night before and 2 hours prior to surgery, respectively.

  During this visit, all the patients will be explained the procedure and will also be taught to interpret the Visual Analogue Scale and how to use  PCA pump.

 In the operating room (OR), intravenous cannulation will be established and after attaching ASA standard monitors such as Electrocardiograph (ECG), non-invasive blood pressure  and Pulse Oximetry  (SPO2) all baseline parameters like ECG, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Blood Pressure , Heart Rate, SpO2  will be recorded. before enrollment and randomization into the study.

In the OT, all patients will be given Inj Midazolam 1mg i.v. After preoxygenating  the patient with 100% Oxygen for three minutes , induction will be carried out with Inj Fentanyl 2mg/kg , Inj Propofol 2mg/kg and Inj. Atracurium 0.5mg/kg which will be followed by tracheal intubation after a complete muscle relaxation. Patient will be put on IPPV after conforming the intratracheal position of the endotracheal tube.

         Anaesthesia will be maintained with Sevoflurane in 50% Oxygen in Air. Target MAC will be between 0.8-1.2. Inj Paracetamol 1g IV will be administered. IV fluids will be given as per Holiday-Segar formula.

        At the end of the procedure, after skin closure, all patients will be given bilateral Rectus Sheath Block under ultrasound guidance and then, will be injected with the study drugs as per the group allocated.

      For patients randomized to Group A,(dexamethasone group) 8 mg will be administered on both sides. Dexamethasone sodium phosphate is supplied in 4mg/ml ampule. For patients randomized to Group B(dexmedetomidine) 1mcg/kg body weight will be administered.

      Neuromuscular blockade will be antagonized with Inj. Glycopyrrolate 0.01mg/kg and Inj. Neostigmine  0.05mg/kg which will be followed by extubation in standard manner.

Rectus sheath block will be performed under ultrasound guidance using a high frequency linear ultrasound probe. A 23 gauge spinal needle will be inserted in medial to lateral orientation, through the subcutaneous tissue, to pierce through the anterior rectus sheath after identification of the sheath and lateral edge of the rectus muscle. The needle will be advanced further through  the body of the muscle until the tip rest on the posterior rectus sheath. After negative aspiration, 10 ml of local anesthetic will be injected along with the study drug. Same procedure will be repeated on the other side.

              Patients will, then, be transferred to the post-anesthesia care unit and observed postoperatively. Parameters like heart rate, blood pressure( Systolic, Diastolic, Mean), and oxygen saturation will be monitored. The intensity of pain will be assessed using VAS score system at 0mins, 10mins, 20 mins and 30mins, and then, at 4th hour, 8th hour, 12th hour, 16th hour, 20th hour and 24th hours by the anesthesiologist (independent observer).

                VAS score is a 10-point horizontal pain scale with 0 representing “no pain” and 10 representing “worst pain imaginable”.

               In PACU, patient will be attached to intravenous PCA pump loaded with Tramadol . Bolus of 20 mg with  lock out time of 10 mins will be 10 set.

                Further, Sedation score (Ramsay Sedation Score), side effects like–

 

nausea, vomiting, and pruritus (categorical scale) will also be noted.

         At the end of 24h, patients will be asked to rate their analgesic satisfaction using VAS.

         In statistical analysis, the primary outcome will be measured as the time of first rescue analgesic used which will be the time duration of analgesia produced by the block.

The secondary outcome variable will be

1.    Total opioid consumption over 24 hours.

2.    Rates of side effect (nausea, vomiting, pruritis) if any within the first  24 hours.

3.    Patient satisfaction utilizing a Likert scale questionnaire on a post-operative day –

4.    Adverse drug reaction caused by drugs used if any.

 
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