| CTRI Number |
CTRI/2026/02/103899 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of epidural bolus and infusion techniques on pain and inflammatory response in gastrointestinal cancer surgery patients |
|
Scientific Title of Study
|
Effect of epidural morphine-ropivacaine combination bolus versus continuous infusion on pain and IL-6, IL-10 levels in patients undergoing gastrointestinal oncosurgeries - a prospective randomized clinical trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aswin Suresh |
| Designation |
Senior Resident, Anaesthesiology |
| Affiliation |
AIIMS Rishikesh |
| Address |
Senior Resident,Department of Anaesthesiology,6th floor,All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9347807356 |
| Fax |
|
| Email |
aswinindian1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajit Kumar |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology,All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9910789377 |
| Fax |
|
| Email |
ajitdr.ajit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajit Kumar |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology,All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India
UTTARANCHAL
249203
India |
| Phone |
9910789377 |
| Fax |
|
| Email |
ajitdr.ajit@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Aswin Suresh |
AIIMS Rishikesh |
SREEPADAM TC 91/892(1) SIVANANDAN ROAD,VENPALAVATTOM ANAYARA P.O TRIVANDRUM
Dehradun
UTTARANCHAL |
09347807356
aswinindian1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS RISHIKESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural morphine-ropivacaine intermittent bolus |
Bolus with morphine 0.05 mg/kg (not more than 3 mg) along with 10 ml of ropivacaine 0.2% approximately 15 min before surgical incision. The dose was repeated every 8–24 h depending on analgesic requirement (Max dose of morphine 8mg in 24 hrs)and to be repeated till 48 hrs postop |
| Comparator Agent |
Epidural ropivacaine-morphine continuous infusion |
6 ml bolus of ropivacaine 0.1% with morphine 0.003% 15 min before surgical incision, followed by infusion at 4 ml/h. The rate of infusion was titrated between 3 and 8 ml/h and continued for 48 hrs to keep VAS scores 4. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA I-III undergoing GastroIntestinal Cancer Surgeries
2) scheduled for elective open GI oncosurgeries
|
|
| ExclusionCriteria |
| Details |
1.Known allergy to Local Anaesthetic Agents and opioids
2.Patients on chronic opioid therapy
3.Patients with spine deformities, post spinal surgeries
4.Patients undergoing thoracic surgeries or VATS
5.Coagulopathy
6. Infection at the injection site
7. Pregnancy
8. Patient refusal
|
|
|
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 compare the efficacy of pain relief between epidural bolus and continuous infusion of epidural morphine-ropivacaine combination using the Numeric Rating Scale (NRS) for pain and to correlate pain scores with serum interleukin levels (IL-6 and IL-10) in patients undergoing major gastrointestinal oncosurgeries |
To compare the efficacy of pain relief between epidural bolus and continuous infusion of epidural morphine-ropivacaine combination using the Numeric Rating Scale (NRS) for pain and to correlate pain scores with serum interleukin levels (IL-6 and IL-10) in patients undergoing major gastrointestinal oncosurgeries for 48 hrs post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of postoperative rescue analgesia consumption
|
Comparison of postoperative rescue analgesia consumption till 48hrs in postop period |
| Comparison of Intraoperative hemodynamics in these 2 groups |
Till the end of surgery bt12-24 hrs duration |
| Comparison of Time to early mobilisation from bed |
within 1-2 week duration postop |
| Comparison of Length of Hospital stay |
1 week -3 week |
| Comparison of quality of life at 3 months |
3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/03/2026 |
| 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
|
Adult
patients (18–70 years), ASA I–III, scheduled for elective open gastrointestinal
cancer surgery will be randomized into two groups of 35 each . Group 1 will receive
epidural morphine–ropivacaine as intermittent bolus doses and Group 2 will
receive the same combination as continuous epidural infusion. All patients will
receive standardized general anaesthesia and multimodal postoperative
analgesia.Primary outcomes are Pain scores will be recorded for 48 hours using NRS and their correlation with inflammatory cytokines(IL -6 and IL -10)levels. Secondary
outcomes include rescue analgesia requirement, intraoperative hemodynamics,
time to mobilisation, length of hospital stay, and quality of life at 3 months
assessed using the FACT-G questionnaire. Study will be Prospective, randomized, open-label, two-arm, parallel-group clinical trial.Duration of study will be 1 yr 6 months . |