| CTRI Number |
CTRI/2023/12/060460 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Benefits of Opioid free Anaesthesia over opioid containing anaesthesia in postoperative period |
|
Scientific Title of Study
|
Comparison of Opioid free Anaesthesia with Opioid Anaesthesia in lumbar spine surgery under general anaesthesia - observational |
| 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 Shifa Ayesha |
| Designation |
POST-GRADUATE STUDENT |
| Affiliation |
YENEPOYA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dr.Shifa Ayesha, Post graduate student, Department of Anaesthesiology, Yenepoya Medical College and Hospital (Deemed to be university), Mangalore.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7406419355 |
| Fax |
|
| Email |
shifa03ayesha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Musti |
| Designation |
Associate Professor |
| Affiliation |
YENEPOYA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dr.Smita Musti, Associate Professor, Department of Anaesthesiology, Yenepoya Medical College and Hospital (Deemed to be university), Mangalore.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886125842 |
| Fax |
|
| Email |
smitamusti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Musti |
| Designation |
Associate Professor |
| Affiliation |
YENEPOYA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dr.Smita Musti, Associate Professor, Department of Anaesthesiology, Yenepoya Medical College and Hospital (Deemed to be university), Mangalore.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886125842 |
| Fax |
|
| Email |
smitamusti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College and Hospital, Deralakatte, Mangalore- 575018.
Karnataka |
|
|
Primary Sponsor
|
| Name |
Yenepoya Medical College and Hospital |
| Address |
Yenepoya Medical College and Hospital (Deemed to be university), Derlakatte, Mangalore-575018 |
| 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 Smita Musti |
Yenepoya medical college hospital |
Yenepoya Medical College and Hospital (Deemed to be university), Derlakatte, Mangalore-575018
Dakshina Kannada
KARNATAKA |
9886125842
smitamusti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants undergoing elective Lumbar Spine Surgery under General Anaesthesia.
2. ASA grade 1 and 2 participants. |
|
| ExclusionCriteria |
| Details |
1.Participants who have previously undergone spine surgery.
2. Participants with clinically significant cardiovascular, respiratory, hepatic, renal, psychiatric or metabolic disease.
3. Haemodynamically unstable participants.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess pain using VAS (visual analog scale) and requirement for rescue analgesics in post-operative period between the three groups.
2.To observe for any adverse effects of opioid free and opioid anaesthesia. |
1.After shifting the patient to post-anaesthesia care unit to 24 hours postoperatively.
2.After shifting the patient to post-anaesthesia care unit to 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to Discharge from PACU |
POSTOPERATIVELY. |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2023 |
| Date of Study Completion (India) |
08/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
An observational study will be undertaken on 51 participants undergoing elective lumbar spine surgery under General Anaesthesia with controlled ventilation. Participants will be categorized into 3 groups based on the intraoperative analgesic used, the 3 groups are as follows- 1. Participants who have received dexmedetomidine. 2. Participants who have received Lidocaine. 3. Participants who have received Fentanyl. Thorough pre-anesthetic evaluation and conduct of anaesthesia will be carried out as per the discretion of the anaesthesiologist. Postoperatively, they will be evaluated for pain scores (VAS), requirement for rescue analgesics, any adverse events, PONV and duration of PACU discharge. |