| CTRI Number |
CTRI/2024/05/068114 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison between opioid-free anaesthesia and opioid-based anaesthesia for
laparoscopic tubal ligation |
|
Scientific Title of Study
|
Comparison between opioid-free anaesthesia and opioid-based anaesthesia for
laparoscopic tubal ligation- A non-inferiority randomized double-blind controlled trial |
| 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 Priyanka |
| Designation |
Post graduate |
| Affiliation |
University college of medical science and GTB hospital |
| Address |
Department of anaesthesiology, UCMS and GTB Hospital, Dilshad garden
North East DELHI 110095 India |
| Phone |
7827067774 |
| Fax |
|
| Email |
sinha6659@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Priyanka |
| Designation |
Post graduate |
| Affiliation |
University college of medical science and GTB hospital |
| Address |
Department of anaesthesiology, UCMS and GTB Hospital, Dilshad garden
North East DELHI 110095 India |
| Phone |
7827067774 |
| Fax |
|
| Email |
sinha6659@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Geetanjali T Chilkoti |
| Designation |
Professor |
| Affiliation |
University college of medical science and GTB hospital |
| Address |
Department of anaesthesiology and critical care,University college of medical science and GTB hospital
East DELHI 110095 India |
| Phone |
09711210772 |
| Fax |
|
| Email |
geetanjalidr@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Main ICU, Second floor, University college of medical science and GTB Hospital, Dilshad garden , New Delhi 110095, India |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
Department of anaesthesiology, Dilshad garden, New Delhi-110095 |
| 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 Priyanka |
University college of medical science and GTB Hospital |
Main ICU second floor, Department of anaesthesiology and critical care, OT block, University college of medical science and GTB Hospital, Dilshad garden East DELHI |
7827067774
sinha6659@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee- human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, (3) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP OB Opioid Based |
Patients will receive the standard opioid-based
anaesthesia using bolus doses of inj fentanyl as per standard protocol. |
| Intervention |
Group OF Opioid Free |
Patients in this group will receive inj. Magnesium sulphate 40mg/kg in 100 ml of saline over 15 minutes (without exceeding 2.5gm) before induction of anaesthesia. Patients will receive inj. Dexamethasone 0.1 mg/kg (diluted making a total volume of 4 ml) after induction of anaesthesia. anaesthesia will be as per standard protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Consenting ASA Physical Status I – II female patients undergoing laparoscopic tubal
ligation under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
BMI more than 35
Known case of allergy to opioids or to adjuvant drugs
Patients with a history of postoperative nausea or vomiting
Patients with history of chronic pain of any aetiology or patients who are already on
opioids
Patients having cognitive dysfunction with inability to comprehend questionnaires. |
|
|
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 |
| AUC- NRS Pain score in 24 hours |
from the time of shifting
the patient from Operation theatre to post-operative area till the completion of 24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Pain intensity using NRS Pain at Rest (NRS-R) & Movement (NRS-M)
2 Rescue analgesic consumption in the first 24 h
3 PONV score
4 Rescue antiemetic consumption in the first 24 h
5 Time to Aldrete score more than or equal to 9
6 Quality of Recovery (QoR-15) score
|
1 Pain intensity using NRS Pain at Rest (NRS-R) & Movement (NRS-M) at the end of 3rd 6th 12th & 24th hr
2 Rescue analgesic consumption in the first 24 h
3 PONV score at at the end of 3rd 6th 12th & 24th hr
4 Rescue antiemetic consumption in the first 24hr
5 Time to Aldrete score more than or equal to 9 measure from the time of shifting the patient to post operative area
6 Quality of Recovery (QoR-15) score at the end of 24 hrs
|
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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)
|
10/06/2024 |
| 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="1" Months="3" 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
|
Opioids are frequently utilized under anaesthesia; however, they are associated with side effects that includes nausea, vomiting, hypotension, respiratory depression/apnoea, bradycardia, somnolence, urinary retention, and constipation, cancer recurrence etc. In recent years, the concept of opioid-free anaesthesia (OFA) has emerged. Opioid-free anaesthesia has been found to be as efficacious as conventional opioid-based anaesthesia (OBA) in terms of decreased incidence of PONV and pain management. Laparoscopic tubal ligation is a common day care laparoscopic gynaecological procedure where OFA protocol may be of greater benefit as these patients are discharged on the same day and avoiding opioids related adverse events with the use of OFA protocol may significantly improve QoR in these patients. Hence this study has been designed with the aim to evaluate and compare the efficacy of OFA and OBA in day care laparoscopic tubal ligation. Patients will be randomly allocated into one of the two groups. Group OB will receive GA using IV fentanyl under standard institutional protocol and Group OF will group will receive magnesium sulphate 40mg/kg in 100 ml of saline over 15 minutes (without exceeding 2.5gm) before induction of anaesthesia and inj. dexamethasone o.1 mg/kg after induction of anaesthesia. The primary outcome is AUC- NRS Pain score in 24 hours. The secondary outcomes are Pain intensity using NRS Pain at Rest (NRS-R) and Movement (NRS-M) at 0-3h, 3-6 h, 6- 12 h, 12 -24 h, Rescue analgesic consumption in the first 24 h, PONV score at 0-3h, 3-6 h, 6-12 h and 12-24 h, Rescue antiemetic consumption in the first 24 h, Intraoperative and postoperative haemodynamic, Time to Aldrete score ≥ 9, Quality of Recovery (QoR-15) score, and adverse events like constipation, urinary retention, nausea, vomiting etc. |