| CTRI Number |
CTRI/2025/10/096430 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How long does Morphine, when given as a part of anesthesia into the back, help with Pain after delivery of baby through surgery? |
|
Scientific Title of Study
|
Prospective observational study to assess the duration of postoperative analgesia in patients undergoing elective lower segment caesarean section under spinal anesthesia with Morphine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SamCharles |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical College, Vellore |
| Address |
SamCharles,
Office,
Department of Anesthesia,
7th Floor Paul Brand Block,
CMC, Vellore
Christian Medical College Vellore,
Ida Scudder Road, Vellore – 632004
Tamil Nadu, India
Vellore
TAMIL NADU
632002
India |
| Phone |
7639789452 |
| Fax |
|
| Email |
samcharles.d.pg@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Smithamol P.B |
| Designation |
Associate professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Smithamol P.B,
Associate Professor,
Office,
Department of Anaesthesia,
7th floor, Paul Brand Block
CMC, Vellore
Christian Medical College Vellore,
Ida Scudder Road, Vellore – 632004
Tamil Nadu, India
Vellore
TAMIL NADU
632002
India |
| Phone |
8940320069 |
| Fax |
|
| Email |
smithamolpb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SamCharles |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical College, Vellore |
| Address |
SamCharles,
Office,
Department of Anesthesia,
7th Floor Paul Brand Block,
CMC, Vellore
Christian Medical College Vellore,
Ida Scudder Road, Vellore – 632004
Tamil Nadu, India
Vellore
TAMIL NADU
632002
India |
| Phone |
7639789452 |
| Fax |
|
| Email |
samcharles.d.pg@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Internal Fluid Fund, Christian Medical College, Vellore |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College Vellore,
Ida Scudder Road, Vellore – 632004
Tamil Nadu, India |
| Type of Sponsor |
Private 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 |
| SamCharles |
Christian Medical College |
Unit 3, unit 4 and unit 5 of the department of Obstetrics and Gynaecology, Christian Medical College Vellore,
Ida Scudder Road, Vellore – 632004
Tamil Nadu, India
Vellore
TAMIL NADU |
7639789452
samcharles.d.pg@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA physical status 2 singleton pregnant mothers over 145 cm in height with no comorbidities or well-controlled comorbidities with normal placentation, undergoing elective lower segment caesarean section at full term |
|
| ExclusionCriteria |
| Details |
Mothers with high-risk pregnancy, multiple pregnancy, or uncontrolled comorbidities. Mothers who undergo lower segment caesarean section under general anesthesia, or those who have failed spinal anesthesia. Mothers who have chronic pain syndrome, allergy to opioids, fetal or placental anomalies. Mothers undergoing preterm or post-term caesarean delivery. Mothers who have postpartum hemorrhage and those who received additives other than morphine 100mcg |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia post intrathecal Morphine as indicated by duration to first patient requested analgesia is the primary outcome. |
Duration of analgesia post intrathecal Morphine as indicated by duration to first patient requested analgesia is the primary outcome. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of respiratory depression defined as respiratory rate less than 10 |
immediate post operative period |
| Incidence of sedation as described by RASS sedation scale |
Immediate post operative period |
| Incidence of post operative nausea and vomiting |
48 hours post operatively |
| Incidence of post operative pruritus |
48 hours after intrathecal morphine administration |
| Duration to flatus |
Time from intrathecal morphine administration to passing flatus first |
|
|
Target Sample Size
|
Total Sample Size="194"
Sample Size from India="194"
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)
|
25/10/2025 |
| 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) |
Open to Recruitment |
|
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
|
Moderate
to severe postoperative pain is experienced by women undergoing lower-segment
caesarean section. Intrathecal
Morphine is proposed as the gold standard for postoperative pain relief in patients
undergoing LSCS. It is a part of
multimodal analgesia in the Enhanced Recovery After Surgery (ERAS) pathway. The duration of analgesia
provided varies between 20 and 48 hours in different populations, with an average of 9.4 hours. This study primarily aims
to determine the duration to the first analgesia requirement after LSCS when spinal anesthesia is provided with intrathecal Morphine. Pain score, as described by
the Visual Analog Scale, at which the patient requested additional analgesia, will
also be recorded. |