| CTRI Number |
CTRI/2023/06/053512 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
03/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The use of intravenous lignocaine to reduce opioid consumption postoperatively and enhance recovery in posterior spine fusion surgeries |
|
Scientific Title of Study
|
Effect of intravenous lignocaine on postoperative opioid consumption and recovery after posterior spine fusion surgeries - A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abinaya G |
| Designation |
Postgraduate |
| Affiliation |
Pondicherry Institute of Medical Science |
| Address |
Department of Anaesthesiology, 2nd floor ETC BLOCK, Pondicherry Institute of Medical Science, Pondicherry.
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9597387124 |
| Fax |
|
| Email |
abinayagnanavel29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sivakumar S |
| Designation |
Head of the Department |
| Affiliation |
Pondicherry Institute of Medical Science |
| Address |
Department of Anaesthesiology, 2nd floor ETC BLOCK, Pondicherry Institute of Medical Science, Pondicherry.
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9944060676 |
| Fax |
|
| Email |
siva85dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sivakumar S |
| Designation |
Head of the Department |
| Affiliation |
Pondicherry Institute of Medical Science |
| Address |
Department of Anaesthesiology, 2nd floor ETC BLOCK, Pondicherry Institute of Medical Science, Pondicherry.
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9944060676 |
| Fax |
|
| Email |
siva85dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences, pondicherry |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry Institute of Medical Sciences, Pondicherry |
| 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 |
| Abinaya G |
Pondicherry Institute of Medical Sciences |
Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Pondicherry
Pondicherry
PONDICHERRY |
9597387124
abinayagnanavel29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M47||Spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous lignocaine |
Group 1 patients will receive intravenous lignocaine 1.5 mg/kg bolus 2 minutes before intubation followed by 1 mg/kg/hr infusion till end of surgery. |
| Comparator Agent |
Normal saline |
Group 2 patients will receive normal saline in the same infusion rate as calculated for the study drug till the end of surgery.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-60 years of either sex.
2. Patients belonging to American society of Anesthesiologist physical status1 and 2.
3. Patients undergoing posterior spine fusion surgeries under General anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Patients with allergy to local anaesthetic.
2. Patients undergoing spinal revision surgery .
3. Patients with bradycardia (HR< 50 bpm) and any rhythm abnormalities
4. Patients with seizure disorders.
5. Patients with uncontrolled diabetes, hypertension, chronic kidney disease, active coronary artery disease and severe COPD and Asthma.
|
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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 |
To determine the effect of intraoperative intravenous lignocaine infusion on postoperative opioid consumption during first 24 hrs after posterior spine fusion surgeries under general anaesthesia in 72 participants.
OUTCOME VARIABLES:
Postoperative opioid consumption
Intraoperative opioid consumption
VAS score in both the groups in first 24 hrs.
Hemodynamic parameters (SBP, DBP & MAP)
Quality of recovery using QOR – 15 scale
|
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the postoperative VAS score in first 24 hrs in both the groups .
2. To compare the hemodynamic parameters (SBP, DBP & MAP) during the intraoperative period in both the groups.
3. To determine the quality of recovery using QOR – 15 scale after 24 hrs of surgery in both the groups.
|
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/06/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
I am doing this study to evaluate the effect of a drug (intravenous lignocaine) on postoperative opioid consumption (pain) and recovery after posterior spine fusion surgery. By being part of this study the patient may have decreased postoperative pain after the surgery and a better postoperative recovery.
|