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CTRI Number  CTRI/2024/09/073871 [Registered on: 13/09/2024] Trial Registered Prospectively
Last Modified On: 11/09/2024
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   A clinical trial to study the effects of the drug dexmedetomidine in improving the treatment of pain after surgery, in patients undergoing caesarean section 
Scientific Title of Study   Efficacy and safety of Dexmedetomidine as an adjuvant in local wound infiltration for postoperative pain relief in caesarean section: a prospective, randomized, double blinded study 
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 Suman Chattopadhyay 
Designation  Professor & Head of the Department 
Affiliation  Midnapore Medical College 
Address  Department of Anaesthesiology, Midnapore Medical College, Vidyasagar Road, Midnapore, Paschim Medinipur

Medinipur
WEST BENGAL
721101
India 
Phone  9830234881  
Fax    
Email  sumanc24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Kumar Mandi 
Designation  Assistant Professor 
Affiliation  Midnapore Medical College 
Address  Department of Anaesthesiology, Midnapore Medical College, Vidyasagar Road, Midnapore, Paschim Medinipur

Medinipur
WEST BENGAL
721101
India 
Phone  8697633923  
Fax    
Email  mandiarunkr87@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nipon Haque 
Designation  Post graduate trainee 
Affiliation  Midnapore Medical College 
Address  Department of Anaesthesiology, Midnapore Medical College, Vidyasagar Road, Midnapore, Paschim Medinipur

Medinipur
WEST BENGAL
721101
India 
Phone  9830956555  
Fax    
Email  wishnipon@gmail.com  
 
Source of Monetary or Material Support  
Government medical college post graduate thesis fund, Office of the Principal, Midnapore Medical College, Vidyasagar Road, Midnapore, Paschim Medinipur, PIN - 721101 
 
Primary Sponsor  
Name  Principal, Midnapore Medical College 
Address  Office of the Principal, Midnapore Medical College, Vidyasagar Road, Midnapore, Paschim Medinipur, PIN - 721101, West Bengal 
Type of Sponsor  Government 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 Nipon Haque  Midnapore Medical College & Hospital  Dept. of Anaesthesiology, 4th floor, Integrated Clinical Building, Vidyasagar Road, Midnapore, Paschim Medinipur, PIN - 721101
Medinipur
WEST BENGAL 
9830956555

wishnipon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Midnapore Medical College  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 
Intervention  Inj. Dexmedetomidine 1 ml (100 mcg)  Inj. Dexmedetomidine 1 ml (100 mcg) administered as adjuvant during local wound infiltration before skin closure. This is to be given only ONCE (i.e. during local wound wound infiltration before skin closure) as a STAT dose. 
Comparator Agent  Inj. normal saline (0.9%) 1 ml  Inj. normal saline (0.9%) 1 ml administered as adjuvant during local wound infiltration before skin closure. This is to be given only ONCE (i.e. during local wound wound infiltration before skin closure) as a STAT dose. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Patients with singleton pregnancy with no obstetric complications (pre-eclampsia, antepartum haemorrhage)
2. Patients undergoing elective caesarean section
3. Patients having ASA grade II
4. Patients with normal BMI (18.5 - 24.9)
5. Patients giving valid consent
 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. Patients with multiple pregancy.
3. Patients with obstetric complications (antepartum haemorrhage, pre-eclampsia).
4. Patients with history of drug abuse.
5. Patients with history of allergy to the study drug dexmedetomidine.
6. Patients with history of diabetes mellitus, heart, liver, kidney, coagulation or mental disorders.
7. Patients with communication disabilities.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The time at which the first analgesic is requested (rescue analgesia) in the postoperative period  At 2, 4, 6, 8, 10 and 12 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Total dose of analgesic consumption in 12 hours in postoperative period  At 12 hours 
Visual analog scale  At 2, 4, 6, 8, 10 and 12 hours 
Heart rate  At 30, 60, 90, 120 minutes 
Mean arterial pressure  At 30, 60, 90, 120 minutes 
Nausea, vomitting  At 2, 4, 6, 8. 10 and 12 hours 
Time of starting movement in postoperative period  At 2, 4, 6, 8, 10 and 12 hours 
Time of starting to eat in postoperative period  At 2, 4, 6, 8, 10 and 12 hours 
Time of initiation of breast-feeding  At 2, 4, 6, 8, 10 and 12 hours 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   22/09/2024 
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 Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  ANY

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 01-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Objective of research:

To compare the efficacy, regarding duration of postoperative analgesia, of local anaesthetic alone and local anaesthetic with dexmedetomidine, as adjuvant, in local wound infiltration in patients undergoing caesarean section.

Background of research:

Postoperative pain and opioid-related adverse drug events are still among the principal factors affecting the rapid recovery and discharge of patients undergoing surgery. It is an important concern for women undergoing caesarean section, a routine surgery in our institute. Breakthrough pain is  a problem in the postoperative period leading to increased opioid consumption.

Addressing postoperative pain in caesarean section is crucial as mothers are expected to recover rapidly and care for the newborn within a few hours following surgery. Effective postperatve analgesia can enhance recovery and decrease morbidity.

Duration of analgesic can be prolonged by systemic or local route. Local wound infiltration before is a tried and tested method of improving postoperative analgesia. It is an easy, effective and affordable technique which can enhance postoperative analgesia in different types of surgeries without major complications. This technique has been shown to play an active role in relieving postoperative pain and reducing opioid consumption. Advantages are safety, simplicty and enhanced postoperative analgesia, especially during mobilisation. In recent years, procedure-specific postoperative pain (PROSPECT) Working Group has recommended wound infiltration for open abdominal surgeries.

Dexmedetomidine is a highly selective agonist of alpha-2 adrenergic receptor with sedative, analgesic but not anaesthetic characteristic, making it a safe adjuvant in various clinical settings. In various studies, dexmedetomidine as an adjucant to local anaesthetics has proven effectiveness for postoperative pain relief in various procedures including abdominal hysterectomy, knee arthroplasty.

Methodology:

This is a single centre, hospital based, double blinded, randomised controlled study on patients posted for elective caesaeran section under spinal anaesthesia, in  the obstetrics operation theatre, the post-anaesthesia care unit and the post-operative ward at Midnapore Medical College & Hospital, Paschim Medinipur, over a period of 12 months. A total of 40 patients will be randomly divided into two groups where one group will receive local wound infiltration with dexmedetomidine as adjuvant and the other grouo will receive local wound infiltration with normal saline as adjuvant. The required parameters will be monitored in the monitored for upto 12 hours in the postoperative period.

Expected outcome of proposed study: 

In this study we expect to find out if in reality dexmedetomidine as an adjuvant to local anaesthetic in local wound infiltrarion can provide superior pain management in terms of duration of postoperative analgesia, total dose of analgesic consumpton in 12 hours post-op, visual analog scale, the time of starting of movement, eating, breast-feeding, adverse effects of medications.
 
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