| CTRI Number |
CTRI/2024/11/077067 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison between two drugs (Ketamine and Gabapentin) in patient population undergoing surgery for spine tumours to relieve post-operative pain |
|
Scientific Title of Study
|
A Comparison of Ketamine versus Gabapentin in post-operative pain assessment in patients undergoing
spinal neoplasms resection: A prospective, randomized, double blinded Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanika Gupta |
| Designation |
Senior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh, Uttarakhand |
| Address |
Department of Anaesthesiology, 6th floor, All India Institute of Medical Sciences, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
dr.kanika71293@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Gupta |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh, Uttarakhand |
| Address |
Department of Anaesthesiology, 6th floor, All India Institute of Medical Sciences, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Gupta |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of Anaesthesiology, 6th floor, All India Institute of Medical Sciences, Rishikesh, Uttarakhand
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh, Uttarakhand - 249203, India |
|
|
Primary Sponsor
|
| Name |
Kanika Gupta |
| Address |
Department of Anaesthesiology, 6th floor, All India Institute of Medical Sciences, Rishikesh, Uttarakhand 249203, India |
| 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 |
| Kanika Gupta |
All India Institute of Medical Sciences, Rishikesh |
Department of Anaesthesiology, 6th floor, AIIMS Rishikesh, Pashulok, Uttarakhand 249203, India
Dehradun
UTTARANCHAL |
8860086543
dr.kanika71293@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C720||Malignant neoplasm of spinal cord, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gabapentin |
Group G – The patients will receive cap. Gabapentin 1200 mg, 60 minutes prior to surgery and saline infusion 0.25mg/kg/hour intra-operatively |
| Intervention |
Ketamine |
Patients with spine neoplasms, meeting the inclusion criteria will be randomly allocated to either of the groups by the computer generated table of random numbers. They will be divided into 3 equal groups-
Group K - The patients will receive placebo capsule 60 minutes before surgery and inj. Ketamine infusion 0.25mg/kg/hour intra-operatively |
| Comparator Agent |
Placebo |
Group P – The patients will receive placebo capsule 60 minutes before surgery and saline
infusion 0.25mg/kg/hour intra-operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-65 years
2. ASA grade I/II/III
3. Patients belonging to either sex
4. Patients planned for elective surgery for spinal tumors
5. Pre-operative motor power of bilateral lower limbs 4+/5 |
|
| ExclusionCriteria |
| Details |
1. Refusal to consent
2. Patient lost to follow-up/not willing for follow-up
3. Known allergy to study drugs
4. Patients with history of substance abuse/addiction other than smoking
5. Patients already on Tab. Gabapentin
6. Patients with pre-existing significant cardiac, respiratory, hepatic, renal disease
7. Pregnancy
8. Patients planned for mechanical ventilation after surgery |
|
|
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 compare Ketamine versus Gabapentin for-
1. Post-operative pain assessment at regular intervals in first 24 hours after surgery using Numeric Rating Scale (NRS) |
Post extubation-
15th minute
2nd hour
6th hour
12th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Ketamine and Gabapentin in terms of-
1. Intra-operative haemodynamic fluctuations
2. Opioid consumption in peri-operative period
3. Requirement of rescue analgesia in post-operative period
4. Adverse effects of study drugs if any
5. Time to first ambulation (hours)
6. Number of hospitalization days
7. Quality of life assessment at the time of hospital discharge and 30 days follow up using
EuroQoL questionnaire |
Intra-operative blood pressure and heart rate monitoring at regular intervals
Rest as mentioned above
|
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
01/12/2024 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.kanika71293@gmail.com].
- For how long will this data be available start date provided 25-11-2024 and end date provided 25-05-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The hallmark symptom of spine tumours is pain in around 90% patients. Patients
having spine neoplasms tend to undergo complex spine procedures which presents as a unique challenge as many of these patients have pre-existing chronic pain and dependence on opioid therapy. The key non-opioid analgesics which have been studied to improve a patient’s peri-operative pain care are non-steroidal anti-inflammatory drugs (NSAID), Acetaminophen, Gabapentinoids (Gabapentin and Pregabalin), Ketamine, Lidocaine, Regional and Neuraxial techniques (local anaesthetic wound infiltration, spinal or epidural catheters, Thoracolumbar interfascial plane blocks and Erector spinae block). With this background, this study is planned to compare and evaluate the analgesic properties of sub-anaesthetic dose of Ketamine infusion with Gabapentin in patients presenting with spinal neoplasms resection. |