| CTRI Number |
CTRI/2024/06/068748 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of intrathecal morphine on postoperative Natural Killer Cell activity in patients undergoing surgery for pancreatobiliary cancers. |
|
Scientific Title of Study
|
The effect of intrathecal morphine on postoperative Natural Killer Cell activity in patients undergoing abdominal surgery for pancreatobiliary malignancy:A randomized control trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIIMS/IEC/2024/5076/08-04-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srinivas Sudheendra Avadhani |
| Designation |
PG Student |
| Affiliation |
All India Institute of Medical Sciences,Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, 3rd floor, DnT block, All India Institute of Medical Sciences (AIIMS), HI Area phase II, Basni, Jodhpur, RAJASTHAN. 342005 India
Jodhpur RAJASTHAN 342005 India |
| Phone |
9900487461 |
| Fax |
|
| Email |
srinivasavadhani444@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Priyanka Sethi |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care , 3rd floor, DnT block, All India Institute of Medical Sciences (AIIMS), HI Area phase II, Basni, Jodhpur, RAJASTHAN. 342005 India
Jodhpur RAJASTHAN 342005 India |
| Phone |
9352206300 |
| Fax |
|
| Email |
dr.priyanka_sethi@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Priyanka Sethi |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care , 3rd floor, DnT block, All India Institute of Medical Sciences (AIIMS), HI Area phase II, Basni, Jodhpur, RAJASTHAN. 342005 India
Jodhpur RAJASTHAN 342005 India |
| Phone |
9352206300 |
| Fax |
|
| Email |
dr.priyanka_sethi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences Jodhpur (AIIMS), HI Area phase II, Basni, Jodhpur, RAJASTHAN. 342005 India |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Jodhpur |
| Address |
All India Institute Of Medical Sciences AICU 3rd Floor Emergency Building DnT Block Jodhpur RAJASTHAN 342005 |
| 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 Srinivas Sudheendra Avadhani |
All India Institute of Medical Sciences, Jodhpur |
Department of Anaesthesiology and Critical Care, 3rd floor, DnT block, AIIMS Hospital, Basni Phase II , Jodhpur, RAJASTHAN Jodhpur RAJASTHAN |
9900487461
srinivasavadhani444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrathecal morphine |
200μg morphine will be administered to the intrathecal space before induction of General Anaesthesia in the operating room. |
| Comparator Agent |
Sham procedure |
Pressure will be applied to the anesthetized skin with a capped syringe without dural puncture before induction of General Anaesthesia in the operating room. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 18 to 65years (American society of anaesthesiologist grading I, II, III) to be taken upfront for major abdominal surgeries for pancreatobiliary malignancy.
|
|
| ExclusionCriteria |
| Details |
1.Patients with ASA grade greater than 3.
2.Patients having chronic pain or any opioid treatment.
3.Patients expected to be requiring postoperative ventilation support.
4.Patients with pre-existing immunodeficiency.
5.Any ongoing infections in patient.
6.Any other chronic inflammatory conditions such as Rheumatoid Arthritis etc.
7.Patients on chemotherapy or radiotherapy.
8.History of blood transfusion in last 15 days
|
|
|
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 measure effect of, addition of intrathecal morphine to post operative pain management regime, on postoperative Natural Killer Cell quantity in patients posted for pancreato-biliary malignancy surgery. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess time for first rescue analgesia in both the study groups. |
24hours |
| To assess Patient satisfaction score using likert scale. |
24hours |
| To calculate total opioid consumption post operatively in both study groups. |
24hours |
| To assess Pain using NRS score following surgery at 6th, 12th, 24th, 36th, 48th hour post operatively. |
48hours |
| To report any side effects like postoperative nausea and vomiting etc. |
24hours |
| To measure the effect on Serum CRP levels postoperatively. |
24hours |
| To assess Quality of recovery using QOR 15 Score postoperatively. |
24hours |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
24/06/2024 |
| 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="6" 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 - NO
|
|
Brief Summary
|
Pain is a complex and subjective experience that involves both sensory and emotional components. It is characterized as an unpleasant sensation associated with actual or potential tissue damage. Acute pain refers to pain that lasts for a short duration, typically not exceeding three months. During the perioperative period, acute pain can occur due to the trauma of surgery, inflammation, and overactivity of the sympathetic nervous system. If not effectively managed, acute pain can progress to chronic persistent post-surgical pain. Studies on animals consistently suggest that poorly controlled pain after surgery can lead to immunosuppression and potentially enhance the development of malignant processes. The most significant effect of this immunosuppression is a decrease in the count and activity of Natural Killer (NK) cells. Additionally, morphine, commonly used for pain management, has been found to have immunosuppressive effects. This may pose a risk for patients who have undergone surgery, as a suppressed immune system can make them more vulnerable to postoperative infections and hinder defense against malignant tumors. Uncontrolled acute perioperative pain can also amplify the surgical stress response. The enhanced activity in the sympathetic nervous system and neuroendocrine responses can further decrease Natural Killer cell activity, potentially increasing the risk of cancer recurrence and metastasis. Natural Killer cells play a crucial role in recognizing and eliminating tumor cells without relying on specific antigens, making them a primary defense mechanism against tumor development and metastases. To evaluate the effects of intrathecal morphine on immune processes in surgery, we are conducting investigations on Natural Killer cell activity using immunological tests. Additionally, pain control without excessive opioid consumption is a challenge for physicians. Intrathecal morphine (ITM) has emerged as a promising alternative that can improve patient outcomes. This is particularly relevant for postoperative analgesia following pancreatobiliary cancer surgery, which often poses challenges due to insufficient pain management. Intrathecal anaesthesia offers a simpler and quicker alternative to epidural anaesthesia, with a lower rate of technical failure. Similar to epidural analgesia, intrathecal morphine has demonstrated efficacy in improving postoperative pain scores and reducing the need for rescue analgesia after major abdominal cancer surgery. This is important considering the significant postoperative pain experienced by patients undergoing definitive surgery for pancreatobiliary malignancies. While intravenous patient-controlled analgesia (IV PCA) and continuous epidural analgesia have been considered standard analgesic modalities for abdominal surgery in patients with malignancies, their use can be controversial. Our study will compare, effect of addition of intrathecal morphine on post operative pain regime of pancreato-biliary malignancy, on quantity of Natural killer cells. We will also compare the cumulative 24-hour IV opioid consumption during the postoperative period between patients who received ITM and those who underwent sham procedures. In addition to pain severity, we will examine variables relating to postoperative recovery profiles, complications, duration of hospital stay, and the impact on serum C-reactive protein (CRP) levels as secondary outcomes. These findings will contribute to our understanding of the immune and pain management processes in perioperative care for patients with pancreatic and biliary malignancies. |