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CTRI Number  CTRI/2023/09/057698 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 13/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare epidural analgesia and recuts sheath analgesia for pain management in abdominal surgery.  
Scientific Title of Study   A comparison of epidural analgesia with recuts sheath analgesia for post operative pain management in abdominal surgery under general anaesthesia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Kumar 
Designation  Assistant Professor 
Affiliation  GGS Medical College and Hospital  
Address  Deptt of anaesthesia GGSMCH Faridkot
GGSMCH Faridkot
Faridkot
PUNJAB
151203
India 
Phone  9464887097  
Fax    
Email  mukeshktala@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh Kumar 
Designation  Assistant Professor 
Affiliation  GGS Medical College and Hospital  
Address  Deptt of anaesthesia GGSMCH Faridkot
GGSMCH Faridkot
Faridkot
PUNJAB
151203
India 
Phone  9464887097  
Fax    
Email  mukeshktala@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sumit Kumar  
Designation  Junior Resident 
Affiliation  GGSMCH 
Address  Deptt of anaesthesia GGSMCH Faridkot
GGSMCH Faridkot
Faridkot
PUNJAB
151203
India 
Phone  9518437940  
Fax    
Email  drsumitkaushik18414@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology GGSMCH Faridkot 
 
Primary Sponsor  
Name  Dr Mukesh Kumar  
Address  Deptt of anaesthesiology GGSMCH Faridkot 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Ashwini Kumar  Deptt of Gen. surgery GGSMCH Faridkot 
Dr Sarvjeet Kaur  Deptt of anaesthesia GGSMCH Faridkot  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sumit Kumar  ,Guru Gobind Singh medical college and Hospital   Deptt of anaesthesiology,Guru Gobind Singh medical college and Hospital
Faridkot
PUNJAB 
9518437940

drsumitkaushik18414@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of GGSMCH Faridkot   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K929||Disease of digestive system, unspecified, (2) ICD-10 Condition: K639||Disease of intestine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  epidural analgesia   Ropivacaine (0.25%)will be given through epidural catheter for post operative pain management in abdominal surgeries.  
Intervention  Recuts sheath analgesia   Ropivacaine (0.25%) will be given through catheters placed in bilateral recuts sheath or post operative pain management in abdominal surgeries.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with ASA 1 and 2
Patients undergoing abdominal surgeries under GA
 
 
ExclusionCriteria 
Details  Patients with allergy to drug
Patients with coagulation disorders
Patient with spine deformities
Patients with abnormalities of spine
Any sign of local infection  
 
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 
To study study postoperative analgesia in patients with epidural analgesia
To study postoperative analgesia in patients with recuts sheath analgesia
 
Till72 hours postoperative  
 
Secondary Outcome  
Outcome  TimePoints 
To compare postoperative analgesia in patients with epidural analgesia and and recuts sheath analgesia   Till 72 hours postoperative  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 Enrollment (India)   25/09/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Neuroendocrine stress caused due to surgery, resulting in undesirable hemodynamic instability, alterations in metabolic response and malfunctioning of the immune system. Pain is a common cause of stress, therefore it should be adequately evaluated and treated both during surgery and afterwards. Pain is a very complex, subjective perceptual phenomenon. It’s dimensions like intensity, quality, duration and impacts varies from patient to patient.

 

Abdominal incision surgeries are still necessary for a number of emergency and elective treatments, despite the rise of less invasive abdominal surgical techniques.

Regional anaesthesia has become an integral and common component of both intraoperative anaesthesia and postoperative analgesia

 

For abdominal, major vascular, and cardiothoracic surgery, thoracic epidural anaesthesia is increasingly employed, followed by post-operative epidural analgesia.Pain management and severe sympatholysis can contribute to improved postoperative outcomes like increased respiratory function, decreased ileus, and protein sparing by allowing patients to cough, breathe deeply, drink, and move around.

 

To successfully do an epidural block, one must have a thorough understanding of the differences between thoracic and lumbar anatomy.Local anaesthetics have different dermatomal sensory distribution depending on where they are injected. Despite having a noticeable caudal spread, high-thoracic epidurals have little cranial spread. In contrast, more cranial distribution happens after low-than-high or mid-thoracic epidurals.

 

Higher concentrations of bupivacaine (0.5%) or its equivalent are preferred, as onset of sensory block is rapid and muscle relaxation is profound, thus reducing the need for intraoperative neuromuscular blocking agents and same can be repeated intraoperative and post operative periods. 

Abdominal trunk local anaesthetic (LA) blocks are one of the multimodal opioid-sparing strategies being used in the therapy of post-laparotomy pain.Effective post-laparotomy analgesia can be achieved while avoiding some of the negative effects associated with opioid and thoracic epidural procedures by using abdominal trunk blocks, such as rectus sheath (RS) and transversus abdominis plane (TAP) blocks.

The paired rectus abdominis muscles and their anterior and posterior sheaths are the key anatomical landmarks of RSCA.Innervation of the anterior abdominal wall arises from the ventral rami of the thoracic nerves (T6-T11), the subcostal nerve (T12), and first lumbar nerve (iliohypogastric and ilioinguinal nerves). The main application of RSCA is for patients undergoing surgery by giving a midline or para-median abdominal incision. 

 

RSCs can be placed before abdominal incision, during surgery with the abdomen open, or after surgery once the abdomen has been closed. RSC insertion must be performed under aseptic conditions. With the patient positioned supine. Manual bolus regimens of 20 ml bupivacaine 0.25% Is given via catheters. 

 

We plan a prospective, randomised study to compare post operative analgesic efficacy of Epidural Analgesia and Rectus Sheath Catheter Analgesia in abdominal surgeries under general anaesthesia by taking count on post operative pain score (VAS Score) and analgesic requirements of patients.

 
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