| CTRI Number |
CTRI/2023/02/050129 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing morphine by two different routes for pain relief. |
|
Scientific Title of Study
|
Comparison Between Intrathecal and Intravenous Morphine for Perioperative Pain Management Following Laparoscopic Nephrectomy on quality of recovery- A Randomized control Trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RICHA SINGH |
| Designation |
SENIOR RESDENT |
| Affiliation |
IGIMS,PATNA |
| Address |
IGIMS WARD BLOCK,FIRST FLOOR,SHEIKHPURA
PATNA
Dr Richa singh,(SR)
depatment of anesthesiology, IGIMS PATNA
Patna
BIHAR
800014
India |
| Phone |
8439789590 |
| Fax |
|
| Email |
richa29.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
IGIMS,PATNA |
| Address |
IGIMS WARD BLOCK,FIRST FLOOR,SHEIKHPURA
PATNA
Patna
BIHAR
800014
India |
| Phone |
9113463130 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
IGIMS,PATNA |
| Address |
IGIMS WARD BLOCK,FIRST FLOOR,SHEIKHPURA
PATNA
Patna
BIHAR
800014
India |
| Phone |
9113463130 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RICHA SINGH |
| Address |
IGIMS DEPARTMENT OF ANESTHESIOLOGY, WARD BLOCK
PATNA |
| 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 |
| Richa Singh |
Indira Gandhi institute of Medical sciences, Patna |
Department of Anesthesiology, Ist Floor.
Patna
BIHAR |
8439789590
richa29.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, (2) ICD-10 Condition: N19||Unspecified kidney failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Morphine |
Morphine 0.1 mg intravenous single injection just before induction |
| Intervention |
Morphine |
Morphine 0.3 microgram per kg body weight single intra thecal injection just before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) physical status I to III, and body mass index between 18 and 35 kg/m2 |
|
| ExclusionCriteria |
| Details |
: inability to consent to the study, coagulopathy, sepsis, hepatic or renal failure, allergy to local anesthetic (LA), pregnancy, and opioid intake at home. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| quality of recovery, assessed by Quality of Recovery15 (QoR-15) scale at 24 h postoperatively |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of side effects like pruritus, sedation, respiratory depression, urinary retention. |
24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2023 |
| 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
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is hypothesized that a single dose of intrathecal morphine (ITM) combined with intravenous analgesic has advantages for
perioperative pain control in order to decreased systemic opioid use and overall quality of recovery would be improved as compared
with IV-morphine with intravenous analgesics. patients will be divided into two groups, first group will receive intra thecal morphine before induction and the other group will receive intra venous morphine before induction. standardized routine IV analgesics will be given to both the groups post-operatively. tramadol will be given as rescue analgesia. Patients will be assessed by using 15-point quality of recovery score, higher the score better will be the quality of recovery. net opioid consumption will be calculated 24 hours post-operatively.
|