| CTRI Number |
CTRI/2020/05/025131 [Registered on: 12/05/2020] Trial Registered Prospectively |
| Last Modified On: |
11/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of three doses of oral gabapentin in reducing pain in patients undergoing gynecologic cancer surgeries |
|
Scientific Title of Study
|
A Comparative study of three different doses of oral Gabapentin as ‘preemptive analgesic’ in patients undergoing elective Gynecologic oncological surgeries under general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R KAVYA |
| Designation |
DNB (PRIMARY) POST GRADUATE |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Department: Anesthiology and pain relief
Room No. :105
Institute: Kidwai Memorial Institute of Oncology
Street: Dr M H Marigowda Road
Area: Hombegowdanagar
City: Bengaluru
State: Karnataka
Bangalore
KARNATAKA
560070
India |
| Phone |
9986713613 |
| Fax |
|
| Email |
kavya.amrutha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RASHMI N R |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Department: Anesthiology and pain relief
Institute: Kidwai Memorial Institute of Oncology
Street: Dr M H Marigowda Road
Area: Hombegowdanagar
City: Bengaluru
State: Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
8792406774 |
| Fax |
|
| Email |
drrashmisatheesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R KAVYA |
| Designation |
DNB (PRIMARY) POST GRADUATE |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Department: Anesthiology and pain relief
Room No. :105
Institute: Kidwai Memorial Institute of Oncology
Street: Dr M H Marigowda Road
Area: Hombegowdanagar
City: Bengaluru
State: Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9986713613 |
| Fax |
|
| Email |
kavya.amrutha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute: Kidwai Memorial Institute of Oncology,
Street: Dr M H Marigowda Road,
Area: Hombegowdanagar,
City: Bengaluru,
State: Karnataka.
|
|
|
Primary Sponsor
|
| Name |
R KAVYA |
| Address |
Institute: Kidwai Memorial Institute of Oncology,
Street: Dr M H Marigowda Road, Area: Hombegowdanagar,
City: Bengaluru,
State: Karnataka
PIN CODE - 560029 |
| Type of Sponsor |
Other [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 |
| R KAVYA |
Kidwai Memorial Institute of Oncology |
Department: Department of Anesthesiology and Pain Relief
Room number :105
Bangalore
KARNATAKA |
9986713613
kavya.amrutha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C53||Malignant neoplasm of cervix uteri, (2) ICD-10 Condition: C54||Malignant neoplasm of corpus uteri, (3) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (4) ICD-10 Condition: C56||Malignant neoplasm of ovary, (5) ICD-10 Condition: C561||Malignant neoplasm of right ovary, (6) ICD-10 Condition: C562||Malignant neoplasm of left ovary, (7) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gabapentin 1200 mg |
Dose: 1200 mg
Time: 1 hour prior to surgery
Route of administration: Oral |
| Comparator Agent |
Gabapentin 600 mg |
Dose: 600 mg,
Time: 1 hour prior to surgery,
Route of administration: Oral
|
| Intervention |
Gabapentin 900 mg |
Dose : 900 mg,
Time: 1 hour prior to surgery,
Route of adminstration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients giving valid informed consent.
Patients aged between 18 – 65 years.
Patients belonging to ASA Grade l and ll.
|
|
| ExclusionCriteria |
| Details |
1.Patients belonging to ASA Grade III and IV.
2.Pregnant patients.
3.Patients with known psychiatric disorders.
4.Patients on sedatives, hypnotics, antidepressant drugs.
5.Patients already taking oral Gabapentin.
6.Patients allergic to opioids and tramadol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of three different doses of oral Gabapentin given one hour prior to surgery as preemptive analgesic to attenuate postoperative pain in patients undergoing elective gynecologic oncological surgeries under General anaesthesia by measuring following
parameters:
heart rate(HR),
systolic blood pressure(SBP),
diastolic blood pressure(DBP),
mean arterial blood pressure(MAP) , sedation score,
VAS score |
VAS(Visual Analogue Score) score for postoperative pain will be noted at 0, 2, 4, 6, 8, 12, 16, 20, 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study and assess the degree of sedation with three different doses of Gabapentin using Ramsay sedation score.
To study and assess the incidence of side effects like dizziness, nausea and vomiting with three different doses. |
24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
13/05/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Prevention and treatment of postoperative pain continues to be a major challenge in postoperative care in gynecologic oncological surgeries and plays an important role in the early mobilization and well-being of the surgical patient.
There are different studies that have proven preemptive analgesic effect of Gabapentin but there are lack of studies regarding the optimal dose of Gabapentin as preemptive analgesic in patients undergoing elective gynecologic oncological surgeries.
The present study is designed to investigate the efficacy of three different doses of Gabapentin (600 mg, 900 mg, 1200 mg) as preemptive analgesic in gynecologic oncological surgeries and thereby finding it’s optimal dose as preemptive analgesic. |