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.
- Conditions
- 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.
- Registration Number
- CTRI/2018/01/011068
- Brief Summary
Patientsundergoing upper abdominal surgeries are known to experience greaterpost-operative pain and distress than any other surgery. Pain due to upperabdominal surgeries, apart from being distressing for the patient, also hampersrespiration, resulting in a higher post-operative respiratory morbidity. Amongvarious analgesic methods available, epidural analgesia is considered the mosteffective and has become the routine post-operative pain management for such surgeries.Epidural morphine gives good quality of pain relief, without the hemodynamicinstability and motor blockade associated with epidural local anaesthetics. Butmorphine has its own side effects, like pruritus, nausea, respiratorydepression; but all these adverse effects are dose dependent.
Epiduralmorphine action is good irrespective of the position of the epidural catheter:Thoracic or Lumbar. Lumbarepidurals give good analgesia even when incision is at thoracic segments sincemorphine is hydrophilic and spreads rostral. Butthe incidence of adverse effects is expected to be high.
While epidural local anesthetics haveshown a clear advantage of reduced dose requirement and consequentreduction in adverse effects when given at concordant levels, the same has notbeen studied with morphine. Thoracic epidural technique is more challengingwhen compared to Lumbar epidural due to the difficult anatomy and the potentialcomplications. So a lumbar epiduralis preferred if it is possible to give analgesia through this route. Butbecause 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 behigher. Administration of morphine at concordant space by reducing therequirement for spread of drug to provide analgesia is expected to reduce thedose requirement and also Thoracic epidural analgesia has shown to decreaseperioperative cardiac adverse events and improve pulmonary function post operatively.
The adverse effects of Morphine can beminimized by using Patient-controlled epidural analgesia (PCEA). PCEA allowspatients to take doses as required, thereby reducing the chances of under oroverdosing.
The study aims to assess the quality of pain relief, amount of Analgesic required andside effect profile of Morphine throughthe use of demand-only PCEA after upperabdominal surgery with the epidural catheter placed at either Thoracic level orLumbar level.
Although it is clear thatlumbar epidural morphine is capable of providing adequate analgesia for upperabdominal surgeries, the difference in dose requirement and adverse effects hasnot been studied. With PCEA, since patients can take just as much morphine asrequired, a difference in dose requirement can be observed if present. Previousstudies have used a fixed dose intermittent bolus, and so it is notpossible to derive if a lesser dose would have been adequate.
Morphine through Thoracic Epidural isexpected to provide adequate post-operative pain relief at a lesser dose withlesser side effects than lumbar epidural.
Morphine can be safely used in PCEA throughThoracic epidural route for a pain free post-operative period.
The hypothesis of this study is "Morphine through Thoracicepidural provides adequate post-operative pain relief with lesser dose and sideeffects compared to Lumbar epidural in patients undergoing upper abdominalsurgeries".
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- Patients scheduled for elective upper abdominal surgery under general anesthesia 2) American Society of Anesthesiologists(ASA) physical status I and II.
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- Patient refusal.
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- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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. 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.
Trial Locations
- Locations (1)
Jawaharlal institute of postgraduate medical education and research
🇮🇳Pondicherry, PONDICHERRY, India
Jawaharlal institute of postgraduate medical education and research🇮🇳Pondicherry, PONDICHERRY, IndiaDr Rajasekar RPrincipal investigator8940137836rajasekar.dx@gmail.com