| CTRI Number |
CTRI/2025/04/084875 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effects of lignocaine and ketamine on pain after surgery. |
|
Scientific Title of Study
|
Comparision of the effects of intraoperative infusion of lignocaine and ketamine on postoperative pain in abdominal surgeries under General Anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrGummalla Abhigna |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Anaesthesia, Second Floor, SMSC Building, Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8919225606 |
| Fax |
|
| Email |
abhigna.gummalla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVivek Chakole |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Anaesthesia, Second Floor, SMSC Building, Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7583836564 |
| Fax |
|
| Email |
drvivekchakole@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVivek Chakole |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Anaesthesia, Second Floor, SMSC Building, Sawangi, Meghe
MAHARASHTRA
442001
India |
| Phone |
7583836564 |
| Fax |
|
| Email |
drvivekchakole@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Meghe, Wardha, India 442001 |
| Type of Sponsor |
Private 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 |
| DrGummalla Abhigna |
Acharya Vinoba Bhave Rural Hospital |
Department Of Anaesthesia, Second Floor, SMSC Building, Sawangi, Meghe
Wardha
MAHARASHTRA |
8919225606
abhigna.gummalla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketamine |
In patients undergoing abdominal surgeries under General Anaesthesia, Intravenous ketamine bolus 0.15 mg/kg will be given before induction of anaesthesia, followed by continuous infusion of 0.15mg/kg/hour. Total duration of intervention will be 4 to 6 hours. |
| Intervention |
Lignocaine |
In patients undergoing abdominal surgeries under General Anaesthesia, Intravenous Lignocaine bolus 1.5 mg/kg will be given before induction of anaesthesia, followed by continuous infusion of 1.5 mg/kg/hour. Total duration of intervention will be 4 to 6 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA grade I,II,III
Patients posted for abdominal surgeries under General Anaesthesia.
Duration of surgery less than 4 Hours.
|
|
| ExclusionCriteria |
| Details |
Pregnant or breastfeeding women
Patients with cardiac, renal, hepatic disease, seizures or other neurological disorders
Patients with chronic preoperative opioid use or substance abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative infusion of Lignocaine prolongs the duration of postoperative analgesia more when compared to Ketamine. |
Assessment of pain will be done every half an hourly till 180 minutes postoperatively, followed by every hourly till 9 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare the effects of intraoperative infusion of
Lignocaine and Ketamine on duration of post-operative analgesia in patients
undergoing Abdominal surgeries under General Anaesthesia. This will be a parallel group randomised trial conducted at Acharya Vinoba Bhave Rural Hospital, Wardha, India. The pain will be assessed at every half an hourly,hourly and three hourly postoperatively till 24 hours.Visual Analogue Scale will be used to assess pain.A total of 80 patients will be enrolled and 40 each will be randomised in two groups. |