| CTRI Number |
CTRI/2021/10/037604 [Registered on: 27/10/2021] Trial Registered Retrospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of ketamine in managing post operative pain following laproscopic cholecystectomy |
|
Scientific Title of Study
|
Efficacy of ketamine for acute and chronic post operative analgesia in laproscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Jain |
| Designation |
Associate Professor |
| Affiliation |
School of Medical Sciences and Research |
| Address |
SMS&R,
Sharda University,
Department of Anaesthesia,
Knowledge Park 3,
Greater Noida
Department of Anaesthesia
Sharda University
Knowledge park 3
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
01204570424 |
| Fax |
|
| Email |
shruti.anaesth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Jain |
| Designation |
Associate Professor |
| Affiliation |
School of Medical Sciences and Research |
| Address |
SMS&R,
Sharda University,
Department of Anaesthesia,
Knowledge Park 3,
Greater Noida
Department of Anaesthesia
Sharda University
Knowledge park 3
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
01204570424 |
| Fax |
|
| Email |
shruti.anaesth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Jain |
| Designation |
Associate Professor |
| Affiliation |
School of Medical Sciences and Research |
| Address |
SMS&R,
Sharda University,
Department of Anaesthesia,
Knowledge Park 3,
Greater Noida
Department of anaesthesia
Sharda University
Knowledge park 3
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
01204570424 |
| Fax |
|
| Email |
shruti.anaesth@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SMSR Sharda University |
| Address |
Knowledge PARK 3 Greater Noida |
| 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 |
| Dr Shruti Jain |
School of Medical sciences and Research |
Department of Anaesthesiology, F block,2nd Floor, Sharda Hospital,
Sharda University
Knowledge park 3
Greater noida
Gautam Buddha Nagar
UTTAR PRADESH |
9212308441
shruti.anaesth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I and II patients undergoing laproscopic cholecystectomy |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine |
0.5ml/kg diluted to 2 ml with normal saline given intravenous 15 minutes prior to surgical incision |
| Comparator Agent |
Normal saline |
2 ml normal saline given intravenous 15 minutes prior to surgical incision. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II patients of either sex, between 20-60 yrs of age, undergoing elective laparoscopic cholecystectomy under general anesthesia, |
|
| ExclusionCriteria |
| Details |
The patients unable to understand NRS, allergic to local anesthetics, had chronic pain disease other than gall stone disease, choledocholithiasis, acute pancreatitis, or were pregnant, were excluded from the study. Whenever surgical procedure necessitated the conversion of laproscopic cholysectomy to open procedure, such patients was also excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The length of time between extubation and the first request for pain medication was recorded.
Chronic pain (NRS score)will be asked from the patient every 15 days on telephone till 6 months. |
The length of time between extubation and the first request for pain medication was recorded.
Chronic pain will be asked from the patient every 15 days on telephone till 6 months post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The total and cumulative consumption of analgesics (tramadol) will be recorded after 24 hours. |
24 hours |
| shoulder pain, nausea, vomiting were also recorded. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/07/2016 |
| Date of Study Completion (India) |
09/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="26" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients undergoing laparoscopic cholecystectomy (LC) experience lesser post-operative pain than conventional cholecystectomy. 1 However, pain remains the dominant complaint of patients on the first post operative day.2,3 Effective post operative analgesia after LC has always remained a clinical challenge. This acute pain also predisposes the development of chronic pain at port sites in LC patients. NMDA is a receptor for the excitatory neurotransmitter glutamate, which is released with noxious peripheral stimuli. The activation of NMDA receptors has been associated with hyperalgesia, neuropathic pain and chronic pain. Thus leading to the possibility that NMDA receptor antagonist may be useful in treatment of chronic pain. Ketamine, a NMDA antagonist may be used as an analgesic which can be used for acute as well as chronic pain in LC patients. |