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CTRI Number  CTRI/2018/01/011068 [Registered on: 01/01/2018] Trial Registered Prospectively
Last Modified On: 26/09/2023
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   A clinical trial to compare the effects and dose requirement of the drug - morphine when given through a catheter placed at a higher point in the vertebral column or at a lower point in the vertebral column in patients undergoing upper abdominal surgeries. 
Scientific Title of Study   Comparison of morphine requirement in thoracic and lumbar epidural in patients undergoing upper abdominal surgeries using patient controlled epidural analgesia – A randomized clinical trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajasekar R 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anesthesiology and Critical care, JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  8940137836  
Fax    
Email  rajasekar.dx@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohan VK 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical care, JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  9841546265  
Fax    
Email  drmohanvk@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Rajasekar R 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical care, JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  8940137836  
Fax    
Email  rajasekar.dx@gmail.com  
 
Source of Monetary or Material Support  
Intramural grant for postgraduate research, Jawaharlal institute of postgraduate medical education and research, Dhanvantri nagar, Gorimedu, Pondicherry- 605006. 
 
Primary Sponsor  
Name  Jawaharlal institute of postgraduate medical education and research 
Address  Jawaharlal institute of postgraduate medical education and research, Dhanvantri nagar, Gorimedu, Pondicherry- 605006. 
Type of Sponsor  Research institution and hospital 
 
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 Rajasekar R  Jawaharlal institute of postgraduate medical education and research  Department of Anaesthesiology and Critical care – Office, Second Floor,Old Block, JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry-605006.
Pondicherry
PONDICHERRY 
8940137836

rajasekar.dx@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee (Human studies), JIPMER, Pondicherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adult patients aged between 18-60 years scheduled for elective upper abdominal surgery under general anesthesia belonging to American Society of Anaesthesiologists (ASA) physical status I and II.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lumbar epidural Group   Estimation of epidural morphine requirement in patients undergoing upper abdominal surgeries using patient controlled epidural analgesia with epidural catheter placed at lumbar spinal level. 
Intervention  Thoracic epidural group  Estimation of epidural morphine requirement in patients undergoing upper abdominal surgeries using patient controlled epidural analgesia with epidural catheter placed at thoracic spinal level. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients scheduled for elective upper abdominal surgery under general anesthesia
2) American Society of Anesthesiologists(ASA) physical status I and II 
 
ExclusionCriteria 
Details  1) Patient refusal.
2) Known case of Coagulopathy
3) Spine deformities
4) Pregnancy
5) Allergy to morphine or lignocaine
6) History of allergic disorders
7) High risk to develop post-operative nausea and vomiting (Apfel score >3)
8) Inability to comprehend pain score or understand use of PCEA
9) Expected prolonged post-operative ventilation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the 24 hour Morphine requirement between Thoracic and Lumbar epidural routes to provide adequate post-operative analgesia in patients undergoing upper abdominal surgeries using PCEA.  Amount of Epidural Morphine (in milligrams) required by the patient for adequate pain relief in the post operative period. It is estimated at the end of 24 hours in post operative period. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare the incidence of Morphine related side effects which includes pruritus, nausea, vomiting, respiratory depression between the two groups  The number of Morphine related side effects in assessed for a period of 24 hours in post operative period. 
To assess and compare the quality of post-operative analgesia of Morphine between the two groups using visual analog scale (VAS) score: at rest (VAS-R) and after coughing (VAS-C)  Visual Analog Score (VAS) (Score 1 - 10) is assessed every 1 hour for the first 6 hours in the post operative period and then at 12 hours and 24 hours in the post operative period. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2018 
Date of Study Completion (India) 01/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Patients undergoing upper abdominal surgeries are known to experience greater post-operative pain and distress than any other surgery. Pain due to upper abdominal surgeries, apart from being distressing for the patient, also hampers respiration, resulting in a higher post-operative respiratory morbidity. Among various analgesic methods available, epidural analgesia is considered the most effective and has become the routine post-operative pain management for such surgeries. Epidural morphine gives good quality of pain relief, without the hemodynamic instability and motor blockade associated with epidural local anaesthetics. But morphine has its own side effects, like pruritus, nausea, respiratory depression; but all these adverse effects are dose dependent. 

Epidural morphine action is good irrespective of the position of the epidural catheter: Thoracic or Lumbar. Lumbar epidurals give good analgesia even when incision is at thoracic segments since morphine is hydrophilic and spreads rostral. But the incidence of adverse effects is expected to be high. 

While epidural local anesthetics have shown a clear advantage of reduced dose requirement  and consequent reduction in adverse effects when given at concordant levels, the same has not been studied with morphine. Thoracic epidural technique is more challenging when compared to Lumbar epidural due to the difficult anatomy and the potential complications. So a lumbar epidural is preferred if it is possible to give analgesia through this route. But because of the distance to which it has to spread to have the analgesic effect, the dose requirement and consequently the adverse effects are expected to be higher. Administration of morphine at concordant space by reducing the requirement for spread of drug to provide analgesia is expected to reduce the dose requirement and also Thoracic epidural analgesia has shown to decrease perioperative cardiac adverse events and improve pulmonary function post operatively. 

The adverse effects of Morphine can be minimized by using Patient-controlled epidural analgesia (PCEA). PCEA allows patients to take doses as required, thereby reducing the chances of under or overdosing.

 The study aims to assess the quality of  pain relief, amount of Analgesic required and side effect profile of Morphine  through the  use of demand-only PCEA after upper abdominal surgery with the epidural catheter placed at either Thoracic level or Lumbar level.

Although it is clear that lumbar epidural morphine is capable of providing adequate analgesia for upper abdominal surgeries, the difference in dose requirement and adverse effects has not been studied. With PCEA, since patients can take just as much morphine as required, a difference in dose requirement can be observed if present. Previous studies have used a fixed dose intermittent bolus, and so it is not possible to derive if a lesser dose would have been adequate.

Morphine through Thoracic Epidural is expected to provide adequate post-operative pain relief at a lesser dose with lesser side effects than lumbar epidural.

Morphine can be safely used in PCEA through Thoracic epidural route for a pain free post-operative period.

          The hypothesis of this study is "Morphine through Thoracic epidural provides adequate post-operative pain relief with lesser dose and side effects compared to Lumbar epidural in patients undergoing   upper abdominal surgeries".

 
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