| CTRI Number |
CTRI/2026/01/101256 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A STUDY COMPARING TWO PAIN RELIEF METHODS AFTER ABDOMINAL HYSTERECTOMY SURGERY |
|
Scientific Title of Study
|
Comparison on the effects of epidural levobupivacaine and morphine for post operative analgesia following total abdominal hysterectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Mohammed Yunus Khilji |
| Designation |
Professor |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anaesthesiology, Sardar Patel Medical college, Bikaner,
Rajasthan.
India
Bikaner
RAJASTHAN
334001
India |
| Phone |
8587858715 |
| Fax |
|
| Email |
mohammedyunus.khilji@nhs.net |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Mohammed Yunus Khilji |
| Designation |
Professor |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anaesthesiology, Sardar Patel Medical college, Bikaner,
Rajasthan.
India
Bikaner
RAJASTHAN
334001
India |
| Phone |
8587858715 |
| Fax |
|
| Email |
mohammedyunus.khilji@nhs.net |
|
Details of Contact Person
Public Query
|
| Name |
DR Mohammed Yunus Khilji |
| Designation |
Professor |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anaesthesiology, Sardar Patel Medical college, Bikaner,
Rajasthan.
India
RAJASTHAN
334001
India |
| Phone |
8587858715 |
| Fax |
|
| Email |
mohammedyunus.khilji@nhs.net |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sardar Patel Medical college, Bikaner,
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology, Sardar Patel Medical college, Bikaner, Rajasthan |
| 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 |
| Dr Mohammed Yunus Khilji |
Sardar Patel Medical College |
OT B block, Janana Hospital
Bikaner
RAJASTHAN |
8587858715
mohammedyunus.khilji@nhs.net |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE,S.P.MEDICAL COLLEGE, BIKANER. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, (2) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural Levobupivacaine |
Patients will receive epidural levobupivacaine 0.25%, 10 mL administered via epidural catheter immediately after completion of surgery for postoperative analgesia following total abdominal hysterectomy. |
| Comparator Agent |
Epidural Morphine |
Patients will receive preservative-free epidural morphine 3 mg diluted to 10 mL with normal saline administered via epidural catheter immediately after completion of surgery for postoperative analgesia following total abdominal hysterectomy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Scheduled for elective total abdominal hysterectomy.
ASA I or II.
Consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Known allergy to local anaesthetics or opioids.
Coagulopathy or local infection at the epidural site.
Chronic opioid neurological disorders use or pre-existing neurological disorder.
Severe hepatic, renal, or cardiovascular disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of effective postoperative analgesia |
Duration of effective postoperative analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain intensity |
VAS at rest and on movement at 2, 4, 8, 12 and 24 hours postoperatively |
| Requirement of rescue analgesia |
Number and total dose of rescue analgesics required within first 24 hours postoperatively |
| Incidence of adverse effects |
Assessed continuously during first 24 hours postoperatively |
| Patient satisfaction score |
Assessed at 24 hours postoperatively |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Total abdominal hysterectomy is associated with significant postoperative pain which may delay recovery and mobilization if not adequately managed. Epidural analgesia is an effective technique for postoperative pain relief in major abdominal surgeries.
This prospective randomized double blind parallel group study aims to compare the efficacy and safety of epidural levobupivacaine and epidural morphine for postoperative analgesia in patients undergoing elective total abdominal hysterectomy. Sixty ASA physical status I and II female patients aged 18 to 65 years will be randomly allocated into two groups. Group L will receive epidural levobupivacaine 0.25 percent 10 mL and Group M will receive preservative free epidural morphine 3 mg diluted to 10 mL with normal saline administered via epidural catheter at the end of surgery.
The primary outcome will be the duration of effective postoperative analgesia defined as time to first request for rescue analgesia. Secondary outcomes include postoperative pain scores using visual analogue scale at predefined time intervals, requirement of rescue analgesia, incidence of adverse effects such as nausea vomiting pruritus respiratory depression hypotension and urinary retention and patient satisfaction scores.
The study aims to determine the optimal epidural analgesic regimen that provides effective pain relief with minimal side effects following total abdominal hysterectomy. |