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
|
|
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
|
|
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". |