| CTRI Number |
CTRI/2021/12/038518 [Registered on: 08/12/2021] Trial Registered Prospectively |
| Last Modified On: |
21/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two different techniques for control of pain during abdominal cancer surgeries. |
|
Scientific Title of Study
|
A comparison of two techniques of postoperative analgesia: multimodal intravenous analgesic technique and epidural ropivacaine infusion in patients undergoing oncological abdominal surgeries – prospective randomized 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 Gitartha Goswami |
| Designation |
DM Senior Resident (Acad.), Oncoanesthesia |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Oncoanesthesia, Dr. BRAIRCH, All India Institute of Medical Sciences, New Delhi, Sri Aurobindo Marg, Ansari Nagar East, South West Delhi- 110029, Delhi, India
South West
DELHI
110029
India |
| Phone |
9864081045 |
| Fax |
|
| Email |
gitarthaamc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Bhatnagar |
| Designation |
Professor, Department of Oncoanesthesia and Palliative Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 242, Department of Oncoanesthesia, Dr. BRAIRCH, All India Institute of Medical Sciences, New Delhi, Sri Aurobindo Marg, Ansari Nagar East, South West Delhi- 110029, Delhi, India
South West
DELHI
110029
India |
| Phone |
9811326453 |
| Fax |
|
| Email |
sushmabhatnagar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma Bhatnagar |
| Designation |
Professor, Department of Oncoanesthesia and Palliative Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 242, Department of Oncoanesthesia, Dr. BRAIRCH, All India Institute of Medical Sciences, New Delhi, Sri Aurobindo Marg, Ansari Nagar East, South West Delhi- 110029, Delhi, India
South West
DELHI
110029
India |
| Phone |
9811326453 |
| Fax |
|
| Email |
sushmabhatnagar1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oncoanesthesia, All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
DR BRAIRCH AIIMS NEW DELHI |
| Address |
Department of Oncoanesthesia, Dr. BRAIRCH, All India Institute of Medical Sciences, New Delhi, Sri Aurobindo Marg, Ansari Nagar East, South West Delhi- 110029, Delhi, India |
| 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 |
| GITARTHA GOSWAMI |
DR BRA.IRCH, AIIMS, NEW DELHI |
Department of Oncoanesthesia, Dr. BRAIRCH, All India Institute of Medical Sciences, New Delhi, Sri Aurobindo Marg, Ansari Nagar East, South West Delhi- 110029, Delhi, India
South West
DELHI |
9864081045
gitarthaamc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH AIIMS ANSARI NAGAR NEW DELHI |
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 |
| Comparator Agent |
Perioperative analgesic management by continuous epidural analgesic technique using ropivacaine. |
For perioperative analgesia epidural catheter will be placed before induction of anesthesia. After confirming epidural placement with a test dose, epidural analgesia will be activated by 6 ml of Ropivacaine 0.2% approximately 15 min before surgical incision and continued throughout intraoperative period at a rate of 0.2% Ropivacaine 5ml/hr. Rescue analgesia will be provided with inj. Fentanyl 0.5mcg/kg boluses depending upon patients BP and HR. Postoperatively, epidural analgesia will be continued at a rate of 5m/hr of 0.1% ropivacaine for 24 hours. For supplemental analgesia Inj. Paracetamol 15mg/kg i.v. and Inj. Diclofenac 1.5mg/kg i.v. will be administered both intraoperatively and postopratively. For postoperative rescue analgesia , patients will be equipped with i.v. PCA fentanyl with bolus doses of 20mcg of Fentanyl, lockout interval of 15 mins and maximum 4 doses in 1 hour. There will be no background infusion. |
| Intervention |
Postoperative analgesic management by continuous perioprative multimodal intravenous analgesic technique using dexmedetomidine, lignocaine and ketamine. |
For perioperative analgesia a combination of three analgesics will be used in the form of Inj. Dexmedetomidine 0.5 mcg/kg i.v. loading dose over 10 mins followed by infusion at a rate of 0.25 mcg/kg/hr, inj. Lignocaine 1.5mg/kg i.v. loading followed by infusion at a rate of 1mg/kg/hr i.v. and inj. Ketamine 0.25mg/kg i.v. loading followed by infusion at a rate of 0.25mg/kg/hr. Rescue analgesia will be provided with inj. Fentanyl 0.5mcg/kg boluses depending upon patients BP and HR. Infusion Dexmedetomidine and Ketamine will be discontinued approximately 30mins before end of surgical procedure. Infusion Lignocaine will be continued postoperatively at a rate of 1mg/kg/hr for 24 hours. For supplemental analgesia Inj. Paracetamol 15mg/kg i.v. and Inj. Diclofenac 1.5mg/kg i.v. will be administered both intraoperatively and postopratively. For postoperative rescue analgesia , patients will be equipped with i.v. PCA fentanyl with bolus doses of 20mcg of Fentanyl, lockout interval of 15 mins and maximum 4 doses in 1 hour. There will be no background infusion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age of 18 years or older, but less than 70 years.
2. Posted for elective oncological abdominal surgeries.
3. Patients giving consent for the procedure.
|
|
| ExclusionCriteria |
| Details |
1. Complicated with mental illness which could interfere with the evaluation of pain scores.
2. Severe heart disease (NYHA classification ≥3)
3. History of epilepsy
4. Any renal or hepatic disorder before surgery.
5. Contraindications of epidural anesthesia.
6. Allergic to any drug used during the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain assessment using Numerical rating scale (NRS). |
After shifting to ICU, 1, 2, 4, 8, 12, 18 and 24 hours in the post-operative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain assessment using NRS during coughing/deep breathing |
After shifting to ICU, 1, 2, 4, 8, 12, 18 and 24 hours in the post-operative period. |
| To compare postoperative IV fentanyl consumption by PCA |
24 hours |
| To compare intraoperative IV fentanyl consumption |
Intraoperative period |
| To compare intraoperative hemodynamic parameters (SBP, DBP, MAP & HR) |
Intraoperative period |
| To compare other postoperative parameters (sedation score, time to first flatus, movement out of bed, postoperative nausea and vomiting) |
Till the day of discharge |
| Any other complications in the IV group |
Till the day of discharge |
| Any other complications in the Epidural group |
Till the day of discharge |
|
|
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)
|
15/12/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Poorly controlled postoperative pain is a major
risk factor for the development of chronic postoperative pain. It has an impact on patient’s quality of life. Recently there has
been a trend towards use of multimodal analgesic technique due to the adverse effects
of opioids like respiratory depression, excessive sedation, pruritus and nausea
vomiting. The anesthesiologist’s armamentarium for
management of postoperative pain has dramatically increased in the recent past
with the availability of a plethora of drugs and techniques. The various
techniques include regional anesthesia and use of a multimodal analgesic
regimen with increased emphasis on the use of analgesic adjuvants like
ketamine, lignocaine, dexmedetomidine and gabapentin or pregabalin. Among
various techniques, epidural analgesia is considered as
the gold standard for both intraoperative and postoperative analgesia in
abdominal surgeries. However, epidural technique has its own side effects like
neuraxial hematoma, infection, trauma to spinal cord and injury to nerve root.
Additionally, epidural catheter placement may be difficult in some patients.
There is limited data on the use of a combination of intravenous lignocaine,
ketamine and dexmedetomidine as a part of opioid free multimodal analgesic
regimen. Hence
in this study we aim to compare the analgesic efficacy of the multimodal
intravenous technique to that of the epidural technique, in terms of
postoperative pain assessment by Numeric Rating Scale score in both the groups. |