| CTRI Number |
CTRI/2024/03/063790 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| 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
|
Comparation of changes in vitals and postoperative pain between 50 mcg and 100mcg spinal morphine in gynaecological oncosurgeries as add on to general anaesthesia |
|
Scientific Title of Study
|
Comparative study of intraoperative hemodynamics and post operative analgesia between 50 mcg and 100 mcg intrathecal morphine in
gynaecological oncosurgeries as adjuvant to general anaesthesia.A prospective randomised control study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Achutuni Lalitha Siva jyothi |
| Designation |
Pg resident (MD) |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Speciality building ,NIZAMS INSTITUTE OF MEDICAL SCIENCES,PANJAGUTTA
NIMS ,PANJAGUTTA
Hyderabad
TELANGANA
500082
India |
| Phone |
9347458598 |
| Fax |
|
| Email |
jyothiachutuni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nirmala jonnavithula |
| Designation |
MD ,professor |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Nizams institute of medical sciences
NIMS ,PANJAGUTTA
Hyderabad
TELANGANA
500082
India |
| Phone |
9849422749 |
| Fax |
|
| Email |
njonnavithula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Achutuni Lalitha Siva Jyothi |
| Designation |
Pg resident (MD) |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Nizams institute of medical sciences,Punjagutta ,Hyderabad
NIMS ,PANJAGUTTA
Hyderabad
TELANGANA
500082
India |
| Phone |
919347458598 |
| Fax |
|
| Email |
jyothiachutuni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams institute of medical sciences, panjagutta ,hyderabad |
|
|
Primary Sponsor
|
| Name |
Achutuni Lalitha Siva jyothi |
| Address |
Pg hostel ,Nizams institute of medical sciences,Punjagutta,Hyderabad |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrAchutuni Lalitha Siva Jyothi |
Nizams institute of medical sciences |
Speciality building ,3 rd floor ,operation theatre complex, table no 3.
Adilabad
TELANGANA |
9347458598
jyothiachutuni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTE |
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 |
| Intervention |
Spinal anesthesia with morphine |
Before general anesthesia patient is given 100 mcg morphine via intrathecal route .procedure last for 10 min and duration of action of morphine is 18 to 20 hours
Intraoperative hemodynamics and post operative analgesia are assessed |
| Comparator Agent |
Spinal morphine |
Intrathecal morphine of 50 mcg dosage |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
With written valid consent
ASA STATUS 1,2
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient opioid allergy
Opioid tolerance
Coagulation disorders
Local site infections
Compromised cardiac respiratory function
Severe diabetes or autonomic neuropathy
On chronic pain medication
Patient with comprehension disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. VAS score of 4 |
1. Baseline
2.at surgical incision
3.Every 15 min from incision for 1 hr
4. Every 30 min for next 2 hrs
5.Immediate post operative
6.Pain for 4 th Hourly for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nausea ,vomiting
Pruritis
Respiratory depression |
From time of surgical incision till 24 hours |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Aim of the study is to reduce the usage of intravenous opioids and side effects by giving low dose intrathecal morphine with less side effects and stable hemodynamics |