| CTRI Number |
CTRI/2024/09/074421 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Ketamine and Bupivacaine in local wound infiltration for postoperative pain in adults undergoing below umbilicus hernia surgery |
|
Scientific Title of Study
|
Comparison of Ketamine and Bupivacaine in local wound infiltration for postoperative analgesia in adults undergoing infraumbilical hernia surgery under spinal anaesthesia - A double blinded hospital based randomized clinical 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 Apoorva S |
| Designation |
Junior Resident |
| Affiliation |
KLE Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, KLE Jawaharlal Nehru Medical College
Belgaum
KARNATAKA
590010
India |
| Phone |
9480945052 |
| Fax |
|
| Email |
appuanju1410@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Gogate |
| Designation |
Professor |
| Affiliation |
KLE Jawaharlal Nehru Medical College, Belgavi |
| Address |
Department of Anaesthesiology, KLE Jawaharlal Nehru Medical College
Belgaum
KARNATAKA
590010
India |
| Phone |
9844083030 |
| Fax |
|
| Email |
vandanagogate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Gogate |
| Designation |
Professor |
| Affiliation |
KLE Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, KLE Jawaharlal Nehru Medical
College
Belgaum
KARNATAKA
590010
India |
| Phone |
9844083030 |
| Fax |
|
| Email |
vandanagogate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, KLE Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Apoorva S |
| Address |
Department of Anaesthesiology, KLE Jawaharlal Nehru Medical College
Belgaum
Karnataka
590010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Apoorva S |
KLE’s Dr. Prabhakar Kore Hospital |
Department of Anaesthesiology, Nehru Nagar
Belgaum
KARNATAKA |
9480945052
appuanju1410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
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 |
Bupivacaine |
Once closure begins the patient will receive wound infiltration with 1 mg/kg Bupivacaine 0.5%. |
| Intervention |
Ketamine |
Once closure begins the patient will receive wound infiltration with 1 mg/kg Ketamine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Grade I-III.
2.Patient undergoing infraumbilical hernia surgery under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal to give consent
2.ASA Grade more than III
3.Pregnant female patients
4.Patients with history of allergy to the study drug
5.Any contraindication for spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of ketamine and bupivacaine after local wound infiltration for postoperative pain |
At 0 min, 15 min and 60 minutes,2, 4,6 ,12 and 24 hours post operatively using visual analogue scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the time for first rescue analgesia.
2.To determine the total amount of analgesic in the first 24 hours post-operatively
3.To determine the adverse effects of the drug, if any
|
Anagesia required in first 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/10/2024 |
| 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="0"
Months="6"
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
|
There is renewed interest in the use of ketamine for postoperative analgesia in recent times. Use of Ketamine infiltration for post operative pain relief shows great promise and has not been studied especially in the Indian population. Hence this study is being undertaken to study the same. |