| CTRI Number |
CTRI/2022/08/045034 [Registered on: 29/08/2022] Trial Registered Prospectively |
| Last Modified On: |
27/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
It is randomized controlled trial to know the efficacy of intrathecal morphine combined with 0.75% ropivacaine heavy for postoperative analgesia in laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Efficacy of intrathecal morphine combined with 0.75% ropivacaine heavy for postoperative analgesia in laparoscopic cholecystectomy- a randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saman Beg |
| Designation |
post graduate trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology ,3rd floor,PBMH,KIMS,KIIT University,Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
795032566 |
| Fax |
|
| Email |
saman.beg.dr18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Panda |
| Designation |
professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of anaesthesiology,3rd floor,PBMH,KIMS,KIIT University,bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
9439862335 |
| Fax |
|
| Email |
amrita.panda@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Panda |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of ansthesiology, 3rd floor, PBMH,KIMS,KIIT University Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
9439862335 |
| Fax |
|
| Email |
amrita.panda@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| kalinga institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 |
| Saman beg |
Kalinga Institute of Medical Sciences |
Department of anesthesiology 3rd floor PBMH, KIMS, KIIT University, Bhubaneswar, Pin-751024
Khordha
ORISSA |
7985032566
saman.beg.dr18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,Kalinga institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.75% Ropivacaine heavy (2ml).
|
The drugs will be given intrathecally.
|
| Intervention |
Morphine (200 micrograms) with 0.75% Ropivacaine heavy diluted to a total volume of 2mL. |
The drug will be given through intrathecal injection. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
All adult male and female patients of age between 18-69 years and belonging to American society of Anaesthesiologist Physical Status I and II posted for elective laparoscopic cholecystectomy.
|
|
| ExclusionCriteria |
| Details |
Patients of age more than 70years.
Any allergy to local anaesthetic, opioids, morphine, NSAIDS or paracetamol.
All contraindication to spinal anaesthesia.
Use of abdominal drains for specific procedure related cause.
Any surgery of duration more than 3 hours.
Patient with body mass index of more than 30 Kg/m2 or any subject requiring ICU admission
|
|
|
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 |
To observe postoperative pain score using NRS scale. (it is a segmented numeric version of visual analog scale in which a patient selects a whole number (0-10) that reflects the intensity of his/her pain.)
Time of first dose of rescue analgesia in hours (from T0 – time of arrival in post anaesthetic care unit). Inj. Tramadol 1.5mg/kg will be administered as rescue analgesic in 100ml normal saline over 15minutes, maximum dose not to exceed 100mg. |
Postoperatively for every 30min for first 2 hours and then after 4hours, 8 hours, 12hours and 24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe postoperative pain score using NRS scale.
Time of first dose of rescue analgesia in hours from T0 time of arrival in post anaesthetic care unit. Inj. Tramadol 1.5mg/kg will be administered as rescue analgesic in 100ml normal saline over 15minutes, maximum dose not to exceed 100mg. Total dose of rescue analgesia consumed in 24hours in mg
To assess possible adverse effects such as pruritus, postoperative nausea and vomiting, and respiratory depression.
To assess respiratory depression (SPO2 94% and respiratory rate12 breaths/minute)
To assess anaesthesiologist satisfaction score based on parameters like able to take oral pain relief medications, able to move around, normal bowel bladder function using 5 point LIKERT SCORE. Residual motor block will be assessed using MODIFIED BROMAGE SCALE.
|
Postoperatively for every 30min for first 2 hours and then after 4hours, 8 hours, 12hours and 24hours. |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
01/09/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is randomazied ,double blinded ,controlled trial . It is to assess the efficacy of intrathecal morphine with 0.75% ropivacaine heavy for postoperative analgesia in elective laparoscopic cholecystectomy which will reduce analgesic requirement during 24 hours. |