| CTRI Number |
CTRI/2026/02/105062 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Different Methods of Pain Relief After Abdominal Surgery |
|
Scientific Title of Study
|
A Comparative Study of Continuous Epidural Analgesia Versus Patient-Controlled Intravenous Analgesia in Postoperative Pain Management in Patients Undergoing Abdominal Surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sri Giridharini |
| Designation |
Junior resident |
| Affiliation |
Chettinad hospital and research institute |
| Address |
12-B sreedharan street Ayyavoo Naidu colony Aminjikarai
Department of anaesthesia 1st floor Chettinad hospital and research institute Rajiv Gandhi Salai Kelambakkam
603103
Chennai
TAMIL NADU
600029
India |
| Phone |
9791045180 |
| Fax |
|
| Email |
sgiridharini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Merlin Shalini Ruth S |
| Designation |
Professor of anaesthesiology |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Chettinad hospital and research institute
Rajiv Gandhi Salai
Kelambakkam
Department of anaesthesia 1st floor Chettinad hospital and research institute Rajiv Gandhi Salai Kelambakkam
603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9790983957 |
| Fax |
|
| Email |
merlin5shalini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Merlin Shalini Ruth S |
| Designation |
Professor of anaesthesiology |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Chettinad hospital and research institute
Rajiv Gandhi Salai
Kelambakkam
Department of anaesthesia 1st floor Chettinad hospital and research institute Rajiv Gandhi Salai Kelambakkam
603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9790983957 |
| Fax |
|
| Email |
merlin5shalini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CHRI |
| Address |
Chettinad hospital and research institute Rajiv Gandhi Salai Kelambakkam chennai 603103 |
| 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 Sri Giridharini |
Chettinad hospital and research institute |
Department of anaesthesia 1st floor Chettinad hospital and research institute
Rajiv Gandhi Salai Kelambakkam
Kancheepuram
TAMIL NADU |
9791045180
sgiridharini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research |
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 |
Continuous epidural analgesia |
Continuous Epidural Analgesia and General Anaesthesia
Patients in
this group will undergo placement of an epidural catheter at the thoracic or lumbar level,
depending on surgical site, under strict aseptic precautions prior to induction. Correct catheter
placement will be confirmed before the administration of general anaesthesia. Postoperatively,
the epidural will be activated with an initial bolus dose to assure effective pain relief. Patients
will then be maintained on a continuous infusion consisting of Bupivacaine 0.125% combined
with Fentanyl 2 µg/mL at 4 mL/hour. Adequacy of analgesia and possible complications will be
closely monitored throughout the postoperative period |
| Intervention |
Intravenous Patient-Controlled Analgesia (IV PCA) |
All patients will receive a standardized general anaesthesia protocol. Premedication will be administered with intravenous Midazolam 1 mg. Patients will be pre-oxygenated with 100% oxygen for 3 minutes, followed by induction using Propofol 1.5–2 mg/kg, Fentanyl 2–3 mcg/kg, and Atracurium 0.5 mg/kg to facilitate endotracheal intubation. Anaesthesia will be maintained with Isoflurane or Sevoflurane at 0.8–1 MAC in an oxygen-air mixture. Intravenous Paracetamol 15 mg/kg will be administered 30 minutes before the end of surgery and continued 8 hourly postoperatively as part of multimodal analgesia.
Postoperative analgesia in this group will be provided using intravenous Patient-Controlled Analgesia (PCA) with morphine. After extubation, an initial intravenous bolus dose of 2 mg morphine will be administered. The PCA device will be programmed to deliver a demand dose of 1 mg morphine with a lockout interval of 20 minutes and no background infusion. Patients will be instructed preoperatively regarding the use of the PCA device. Pain scores will be assessed at predefined intervals, and patients will be monitored for opioid-related adverse effects such as nausea, vomiting, sedation, pruritus, and respiratory depression. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-70 years, ASA physical status I-III undergoing elective
abdominal surgeries. Patients able to communicate pain intensity effectively and operate the
PCA device independently |
|
| ExclusionCriteria |
| Details |
Allergy to study drugs, coagulopathy or
anticoagulation therapy, and infection at the insertion site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of postoperative pain scores between the two groups using Visual Analog Scale (VAS) |
2,6,12,24,48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total opioid consumption in 24 hours
Requirement of rescue analgesia
Quality of recovery (QoR-15 score)
Hemodynamic parameters (HR, BP)
Incidence of adverse effects:
Hypotension
Bradycardia
Nausea/vomiting
Sedation
Respiratory depression |
2,6,24,48hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/03/2026 |
| 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="0"
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
|
Postoperative pain management plays a crucial role in enhancing recovery and reducing complications following abdominal surgeries. Continuous Epidural Analgesia (CEA) and Intravenous Patient-Controlled Analgesia (IV PCA) are commonly used modalities for postoperative pain relief, each with its own advantages and limitations. This prospective randomized comparative study aims to evaluate and compare the efficacy of continuous epidural analgesia and intravenous patient-controlled analgesia in patients undergoing abdominal surgeries. All patients will receive standardized general anaesthesia. Postoperatively, one group will receive continuous epidural infusion of local anaesthetic with opioid, while the other group will receive intravenous morphine through a patient-controlled analgesia pump. Postoperative pain scores, opioid consumption, quality of recovery, hemodynamic parameters, and adverse effects will be assessed and compared between the two groups. |