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Clinical Trials/CTRI/2024/07/070845
CTRI/2024/07/070845
Not yet recruiting
Phase 4

A randomized comparative study of postoperative analgesic requirement in robot assisted versus laparoscopic urology study

Sawai Man Singh Medical College and attached hospitals Jaipur1 site in 1 country60 target enrollmentStarted: July 26, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Sawai Man Singh Medical College and attached hospitals Jaipur
Enrollment
60
Locations
1
Primary Endpoint
1 To assess and compare analgesic requirement in first 24 hours in both study groups

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

1 To assess and compare analgesic requirement in first 24 hours in both study groups

Time Frame: 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

2 To assess and compare Mean NRS score between study groups at 0-1-2-4-6-12-24 hours

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
Sawai Man Singh Medical College and attached hospitals Jaipur
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Varsha kothari

SMS Medical College

Study Sites (1)

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