| CTRI Number |
CTRI/2023/03/050949 [Registered on: 21/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| 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
|
Comparison of conventional vs multimodal analgesia in attenuation of stress response to carboperitoneum and post operative analgesia in laparoscopic abdominal surgeries |
|
Scientific Title of Study
|
Comparison of conventional vs multimodal analgesia in attenuation of stress response to carboperitoneum and post operative analgesia in laparoscopic abdominal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Bawdekar |
| Designation |
Associate professor |
| Affiliation |
Dr D Y patil medical hospital and research centre kadamwadi kolhapur |
| Address |
Associate professor
Department of anesthesiology
Dr D Y patil medical hospital and research centre kadamwadi kolhapur maharastra
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9448866819 |
| Fax |
|
| Email |
rashbawdekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Bawdekar |
| Designation |
Associate professor |
| Affiliation |
Dr D Y patil medical hospital and research centre kadamwadi kolhapur |
| Address |
Associate professor
Department of anesthesiology
Dr D Y patil medical hospital and research centre kadamwadi kolhapur maharastra
MAHARASHTRA
416003
India |
| Phone |
9448866819 |
| Fax |
|
| Email |
rashbawdekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NITA PADMINI |
| Designation |
Post graduation Resident |
| Affiliation |
Dr D Y patil medical hospital and research centre kadamwadi kolhapur |
| Address |
PG resident
Department of anesthesiology
Dr D Y patil medical hospital and research centre kadamwadi kolhapur maharastra
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
8280012326 |
| Fax |
|
| Email |
pnita7572@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR D.Y.PATIL medical hospital and research center,kadamwadi,kolhapur,maharastra |
|
|
Primary Sponsor
|
| Name |
DR. D.Y.PATIL medical hospital and research center |
| Address |
kadamwadi, kolhapur
maharastra
416003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rashmi Bawdekar |
Dr D.Y.Patil medical hospital and research center, kadamwadi, kolhapur |
Department of Anaesthesiology
Kolhapur
MAHARASHTRA |
9448866819
rashbawdekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
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 |
| Comparator Agent |
conventional vs multimodal |
Drugs will be given 15min prior to surgery and will not be repeated further during surgery(surgical procedure of duration more than 30min to less than 3hours are included in the study) |
| Comparator Agent |
inj Paracetamol 1G IV
inj Mgso4 1G IV
inj Loxicard 60mg iv
inj Dexamethasone 8mg iv
inj Dexamethasone
|
Comparison between conventional(inj Paracetamol 1gm iv single dose 15min prior to surgery) and multimodal analgesic drugs(inj Mgso4 1gm iv+inj loxicard 60mg iv+inj paracetamol 1gm iv and inj dexamethasone 8mg iv-15min proir to surgery)
All the drugs will be given as single doses and will not be repeated till the end of the procedure.(included surgical procedures 30min to 3hours ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)patients undergoing laparoscopic abdominal surgeries
2)ASA grade 1 and 2
3)laparoscopic abdominal surgeries more than 30min to less than 3hours |
|
| ExclusionCriteria |
| Details |
1)patient refusal
2)known or suspected allergy to any of the drugs used.
3)psychiatric illness. |
|
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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 |
| To observe and compare the effect of conventional and multimodal analgesia in attenuation of haemodynamic stress response to carboperitoneum in laparoscopic abdominal surgery. |
The haemodynamic stress response. The haemodynamic parameters(HR,SBP,DBP,MAP,ETCO2) will be studied at baseline value, after completion of the study analgesic solution , immediately after intubation, before carboperitoneum and immediately after carboperitoneum, at 5min,10min,20min,30min and every 30min upto the end of carboperitoneum. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe and compare the effect of conventional and multimodal analgesia in post operative pain relief in laparoscopic abdominal surgeries. |
Postoperative analgesia will be assessed using the VAS score at 5min,15min,2hrs,4hrs and 6hrs. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 |
|
Date of First Enrollment (India)
|
25/03/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
multimodal analgesic strategies have caused major improvements in pain management with increased efficacy and better tolerability along with opoid sparing effect.in our study we intend to study if multimodal analgesia is more beneficial compared to conventional analgesia in attenuation of stress response to carboperitoneum and post operative analgesia. Null hypothesis- iIn laparoscopic abdominal surgeries, there is no difference between multimodal and conventional analgesia in reduction of stress response to carboperitoneum and post operative analgesia. |