| CTRI Number |
CTRI/2024/07/070845 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of postoperative pain in robot assissted versus laproscopic urology surgery |
|
Scientific Title of Study
|
A randomized comparative study of postoperative analgesic requirement in robot assisted versus laparoscopic urology 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 |
Dr Varsha kothari |
| Designation |
Senior professor |
| Affiliation |
SMS Medical College |
| Address |
Department ofAnaesthesiology, Second floor, Dhanwantari building, SMS Medical College, Jaipur, RAJASTHAN 302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
982820186 |
| Fax |
|
| Email |
vkothari66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha kothari |
| Designation |
Senior professor |
| Affiliation |
SMS Medical College |
| Address |
Department ofAnaesthesiology, Second floor, Dhanwantari building, SMS Medical College, Jaipur, RAJASTHAN 302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
982820186 |
| Fax |
|
| Email |
vkothari66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indu Phogat |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College |
| Address |
Department of anaesthesiology, Second Floor, Dhanwantari building, SMS Medical College, Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
7024132239 |
| Fax |
|
| Email |
Induphogat2@gmail.Com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sawai Man Singh Medical College and attached hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and attached hospitals Jaipur |
| Address |
Department of Anesthesiology, Second floor, Dhanvantri complex S.M.S Medical College, Jaipur, Rajasthan |
| Type of Sponsor |
Government 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 |
| Dr Indu phogat |
Sawai Man Singh Medical College and attached hospitals |
Urology Operation Theatre seventh Floor Super Specialty Building SMS Medical College and Attached Hospitals
Jaipur RAJASTHAN
Jaipur
RAJASTHAN |
7024132239
Induphogat2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee SMS medical College and attached hospitals Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N288||Other specified disorders of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Post operative analgesic dose required |
To compare post-operative analgesic requirement in robot assisted versus laparoscopic urology surgery in first 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient consenting to participate belonging to American Society of Anesthesiologist (ASA) I - III aged 18-75 years undergoing elective robotic or conventional laparoscopic urology surgery. |
|
| ExclusionCriteria |
| Details |
Patients not consenting to participate
Severe coronary artery disease
Severe valvular heart disease
Allergy to paracetamol tramadol fentanyl
History of excessive alcohol or drug abuse
Patients who are part of other study |
|
|
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 To assess and compare analgesic requirement in first 24 hours in both study groups
2 To assess and compare Mean NRS score between study groups at 0-1-2-4-6-12-24 hours |
1 To assess and compare analgesic requirement in first 24 hours in both study groups
2 To assess and compare Mean NRS score between study groups at 0-1-2-4-6-12-24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess & compare various hemodynamic parameters(heart rate, systolic blood pressure, diastolic blood pressure, spO2) at various interval in both groups
2 To assess & compare time to ambulation
3 To assess & compare length of icu stay |
1 To assess & compare various hemodynamic parameters(heart rate,systolic blood pressure, diastolic blood pressure, spO2) at various interval in both groups
2 To assess & compare time to ambulation
3To assess & compare length of icu stay |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/07/2024 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The shift from open to minimally invasive urology surgery, driven by advancement in imaging, endoscopic technology offer benefits like early ambulation, quicker recovery, reduced cost of hospital stay, reduced analgesic requirements. The postsurgical pain and the morbidity patients undergo is more frequently due to traumatic injury while gaining access to intended site of surgery rather than surgery itself. Inadequate analgesia may lead to postoperative complications, such as arterial hypertension, intracranial hemorrhage, prolonged hospital stay and increased mortality. Moreover, acute postoperative pain is associated with an increased risk of chronic pain.Therefore optimal analgesic treatment is essential for improving the quality of pain management after surgeries. Robots improve field visibility with greater depth perception, fine movement control, and enable more ergonomic anatomic movements of instruments closely mimicking human wrist movements. While the technical ease of resection and surgeon’s instrumentation freedom are discussed in detail in many studies. There is limited studies on anesthetic implications, analgesic requirements and benefits of robot assisted surgery over laparoscopic surgeries. Hence, we designed this study to compare postoperative analgesic requirement between robot assisted versus laparoscopic urology surgery in the first 24hrs after surgery. |