A study to assess outcomes in patient posted for surgery - with or without opioids as a part of general anaesthesia

Not yet recruiting

• Conditions: Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K819||Cholecystitis, unspecified, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: N809||Endometriosis, unspecified, (5) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (6) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, (7) ICD-10 Condition: N849||Polyp of female genital tract, unspecified,

• Registration Number: CTRI/2025/05/087495
• Lead Sponsor: Akansha lata

Brief Summary

Opioid free anaesthesia is a technique where the intraoperative use of systematic , neuraxial or intracavitary opioid is completely eliminated . restricting opioid use in anaesthesia has shown variable effectiveness in different surgeries and patient population . whereas on one hand , the opioid consumption is reduced intraoperatively, effective nociception and reduction in postoperative opioid consumption is still under investigation with OFA.

The commonly used armamentarium of non opioid analgesia includes local anaesthetics , clonidine , dexmedetomidine, ketamine , gabapentin , magnesium sulphate and dexamethasone

The spectrum of opioid free anaesthesia can be of prime utility in patient at high risk of opioid related respiratory complication such as patient with obstructive sleep apnoea , patient posted for bariatric surgeries and patient with pulmonary limitation including obstructive airway diseases

Opioid free anaesthesia also offer particular advantages in opioid tolerant patient such as patient with chronic pain , cancer related pain and patient suffering from opioid addiction .

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-21
• Study Start: 2025-06-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Aged greater than 18 years Booked for elective laparoscopic or superficial surgeries American Society of Anaesthesiologists physical status grade I-II Surgeries lasting less than 3 hrs.

Exclusion Criteria

Pregnant women Body Mass Index greater than 35 Allergy to opioids Allergy to adjuvant drugs Persistent opioid use Non elective surgery Surgeries lasting more than 3 hrs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain scores VAS scores (0-10)	Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr
8th hr	Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr
24hr	Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr
Primary outcome	Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr
Pain parameters	Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr
2nd hr	Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes	PONV

Trial Locations

Locations (1)

All India Institute of Medical Science , Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

All India Institute of Medical Science , Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

Dr Akansha Lata

Principal investigator

06397850633

akanshalata00006@gmail.com