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CTRI Number  CTRI/2024/11/076412 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 02/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dexmedetomidine versus low molecular weight dextran will be used as adjuvant to Ropivacaine in ultrasound guided erector spinae plane block for postoperative analgesia in patients undergoing Total Abdominal Hysterectomy. 
Scientific Title of Study   Dexmedetomidine versus low molecular weight dextran as adjuvant to Ropivacaine in ultrasound guided erector spinae plane block for postoperative analgesia in Total Abdominal Hysterectomy 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arnpriya Pal 
Designation  Junior Resident Anaesthesia 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Anaesthesia, Himalayan Institute of Medical Sciences, jolly grant, Dehradun.

Dehradun
UTTARANCHAL
248140
India 
Phone  8755274027  
Fax    
Email  arnpriyapal1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Harish Koshyari 
Designation  Associate Professor 
Affiliation  Himalayan Institute of medical Sciences 
Address  Department of Anaesthesia, Himalayan Institute of Medical Sciences, jolly grant, Dehradun.

Dehradun
UTTARANCHAL
248140
India 
Phone  8979678923  
Fax    
Email  harish834@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Harish Koshyari 
Designation  Associate Professor 
Affiliation  Himalayan Institute of medical Sciences 
Address  Department of Anaesthesia, Himalayan Institute of Medical Sciences, jolly grant, Dehradun.

Dehradun
UTTARANCHAL
248140
India 
Phone  8979678923  
Fax    
Email  harish834@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun 
 
Primary Sponsor  
Name  Swami Rama Himalayan University 
Address  Himalayan Institute of Medical Sciences, SRHU, Jolly grant, Dehradun, Uttrakhand, India. 248140 
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 Arnpriya Pal  Swami Rama Himalayan University  Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Jolly grant 248140
Dehradun
UTTARANCHAL 
8755274027

arnpriyapal1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SWAMI RAMA HIMALYAN UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector Spinae Plane block  Group A (Control group): 40ml 0.25% Ropivacaine(20ml on each side) in Normal Saline (in 1:1 ratio) 
Comparator Agent  ESPB with Ropivacaine and Dexmedetomidine  Group B: 40ml 0.25% Ropivacaine(20ml on each side)+ Dexmedetomidine 0.75μg/kg  
Comparator Agent  ESPB with Ropivacaine and low molecular weight dextran  Group C: 40ml 0.25% Ropivacaine(20ml on each side)+ low-molecular weight dextran in (1:1 ratio) 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  ● All Patients giving written informed consent
Females undergoing elective Abdominal Hysterectomy surgeries.
American Society Of Anaesthesiology(ASA) physical status Grade I, II
Incision- Pfannenstiel
 
 
ExclusionCriteria 
Details  Patient’s refusal to participate in study
Cognitive impairment or active psychiatric condition
Infection at local site
Bleeding disorders
Contraindications to any of the drugs used in the study(allergy)
Lactation
Drug abuse
Severe liver and kidney disease
ASA≥3
Midline incision
Dyscholestrolemia
Severe cardiovascular/Respiratory risk
Coagulation disorders
Allergy to local anaesthetic 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
total amount of opioid consumption in first 24 hours  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time of first rescue analgesic request( time from PACU shifting to first requested rescue analgesic)  24 hours 
Total amount of prescribed analgesic in PACU  24 hours 
Any opioid related side effects like respiratory depression, pruritis within the first 24 hours.  24 hours 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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 4 
Date of First Enrollment (India)   20/11/2024 
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  

The present study will be conducted in the Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Swami Ram Nagar, Dehradun over a period of 12 months after obtaining an informed written consent from the patients and ethical clearance from the institutional ethics committee. Patients undergoing Total Abdominal Hysterectomy under general anaesthesia in the Obstetrics and Gynaecology department at Himalayan Institute of Medical Sciences, Swami Ram Nagar, Dehradun will be included in the study. 

Sample Size: In Uttarakhand, the proportion of women who had hysterectomy is 2.1% based on the data of NFHS-4 (16). Sample size is calculated using the formula

n = Z2(1- α /2) P(1-P)

                   L2

where,

n = required sample size

z= 1.96 at 0.05 level of significance

p=proportion of hysterectomy which has been taken as 0.021

L= 5% of absolute precision

n=1.96x1.96x0.021x0.98/(0.05)2

n=32 in each group

32 patients each will be included in 3 groups and hence total 96 patients will be included in the study.

All selected patients will undergo routine pre anaesthetic checkup which includes complete history, physical examination and routine laboratory investigations.

●        Patients will be divided into 3 groups (32 patients each)

1.     Group A (Control group): 40ml 0.25% Ropivacaine(20ml on each side) in Normal Saline (in 1:1 ratio)

2.     Group B: 40ml 0.25% Ropivacaine(20ml on each side)+ Dexmedetomidine 0.75μg/kg

3.     Group C: 40ml 0.25% Ropivacaine(20ml on each side)+ low-molecular weight dextran in (1:1 ratio)

Upon completion of surgery, 

Erector spinae plane block will be performed under USG guidance using a high frequency linear probe/transducer in lateral position. The transducer will be placed in a parasagittal orientation 3cm lateral to T9 spinous process.

●       Patient Controlled analgesia (PCA) pump with morphine will be used as analgesic supplement so that patient can herself administer morphine when required. PCA pump will be started with concentration of 1mg/ml of morphine, demand dose of morphine through PCA pump will be 1.5 ml with lockout interval of 15 minutes, maximum limit in 4 hrs will be 20 mg. Along with it, paracetamol 1 gm i.v. will be given every 8 hourly.

●       The time duration of the first rescue analgesic request from the time patient was shifted to PACU, PCA pump press number, number of times drug is delivered and total morphine consumption in 24 h postoperatively will be recorded in all three groups. However if pain persists even after administration of morphine and PCM, diclofenac 75 mg i.v. will be used as a rescue analgesic.

QoR 40 questionnaire will be used postoperatively to measure the quality of recovery after anaesthesia on the third post-operative day .

●       Adverse effects if any will be noted, including nausea and/or vomiting and if present treated with ondansetron 0.1 mg/kg i.v.Hypotension (mean arterial pressure <20% of baseline or <60 mmHg) treated with an infusion of normal saline and if necessary an i.v. injection of ephedrine 5–10 mg incremental doses will be administrated. Bradycardia (heart rate <60 beats/min) will be treated with i.v atropine 0.01mg/kg bolus.

●       In statistical analysis the primary outcome will be the total amount of opioid consumption in first 24 hours

●       The secondary outcome variable will be:

1.     Time of first rescue analgesic request( time from PACU shifting to first requested rescue analgesic)

2.     Total amount of prescribed analgesic in PACU

3.     Any opioid related side effects like respiratory depression, pruritis within the first 24 hours.


 
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