| CTRI Number |
CTRI/2024/02/062614 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| 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
|
Gabapentin, Dexamethasone, Paracetamol and Ketorolac combination for pain relief and opioid sparing effects in modified radical mastectomy |
|
Scientific Title of Study
|
To compare the opioid sparing effects of combination of Gabapentin, Dexamethasone, Paracetamol and ketorolac (GaDexPaK) vs Dexamethasone, Paracetamol and Ketorolac (DexPaK) in patients undergoing Modified Radical Mastectomy: A Prospective Double Blind Randomised Controlled 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 |
Parin Lalwani |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology , Pain Medicine and Critical Care,
Room no 1 Porta cabin Fourth Floor Teaching Block,AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9650533388 |
| Fax |
|
| Email |
drparinlalwani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parin Lalwani |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology , Pain Medicine and Critical Care,
Room no 1 Porta cabin Fourth Floor Teaching Block,AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9650533388 |
| Fax |
|
| Email |
drparinlalwani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maheshwaran S |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology , Pain Medicine and Critical Care, AIIMS New
Delhi.
South
DELHI
110029
India |
| Phone |
8825783576 |
| Fax |
|
| Email |
maheshmad22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Parin Lalwani |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care. AIIMS, New Delhi. South Delhi |
| 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 Parin Lalwani |
Department of Anaesthesiology, Pain Medicine and Critical care |
All India Institute of Medical Sciences, Ansari Nagar east, New Delhi, 110029
South
DELHI |
9650533388
drparinlalwani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for postgraduate research, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gabapentin, Dexamethasone, Paracetamol, Ketorolac |
Tab. Gabapentin 600mg orally and intravenous dexamethasone 0.2mg/kg will be given 1 hr before surgery. Intravenous paracetamol 1gm and Ketorolac 30mg will be given before induction of anaesthesia |
| Comparator Agent |
Placebo tablet ( calcium carbonate), Dexamethasone, Paracetamol, Ketorolac |
Placebo tablet ( tab. Calcium carbonate 500mg) orally and intravenous Dexamethasone 0.2mg/kg will be given 1hr before surgery. Intravenous Paracetamol 1gm, Ketorolac 30mg will be given before induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients of ASA physical status I and II posted for elective Modified Radical Mastectomy |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Known allergy to the drug
3. H /O gastric or duodenal ulcer
4. H/O Asthma
5. H/O Diabetes mellitus
6. Pregnancy
7. Chronic analgesic or steroid or opioid consumption
8. Patient who is already on gabapentin or any other antiepileptic drugs or antidepressant or benzodiazepines
9. Impaired kidney and liver function
10. BMI >30
11. Limitations in understanding use of PCA pump
12. H/O Migraine or Chronic Pain |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Intravenous Patient Controlled Analgesia (PCA) fentanyl consumption in the first 24 hours postoperatively. |
24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Time for first analgesic requirement
2) Post operative pain scores at rest & during movement
0 min, 15 min, 30 mins, 1, 2, 4, 8, 12 and 24h
3) PONV
4) Wound healing/ infection at 1 week |
1) 24 hours postoperatively
2) 0 min, 15 min, 30 mins, 1, 2, 4, 8, 12 & 24hours
3) 0 min, 15 min, 30 mins, 1, 2, 4, 8, 12 and 24hours
4) 7 days postoperatively |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
21/02/2024 |
| 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="2"
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
|
Modified radical mastectomy attributed for 31% of all breast surgeries and is preferred over other surgeries because of its cosmetic and functional supremacy. Regardless of being the commonly done surgery, one of the terrible complications of MRM is acute Intraoperative and postoperative pain due to the handling of substantial amount of breast tissue, axillary lymph nodes and intercostal nerves. Opioids are one of the most commonly used medications but they are accompanied with a wide range of side effects like nausea, vomiting, constipation, excessive sedation, clouded sensorium, dizziness, respiratory depression, and addiction. Hence a practice of multimodal analgesia using primarily acetaminophen, non-selective NSAIDS, selective COX-2 (cyclooygenase) NSAIDS, steroids , GABA agonist[gabapentin] is used. Our study is designed to compare the analgesic efficacy and effect on opioid sparing effect of Gabapentin, Dexamethasone, Paracetamol and ketorolac combination with Dexamethsone, Paracetamol and Ketorolac combination in patients undergoing modified radical mastectomy.
All the patients recruited in the study will be divided into 2 groups Group D - Tab. Gabapentin 600mg orally + Dexamethasone (0.2mg/kg) i.v in 100 ml saline over 15 minutes, 1 hr before surgery and PCM 1g + Ketorolac 30mg I.V before induction Group C - Placebo tablet(Calcium carbonate 500 mg) orally + Dexamethasone(0.2mg/kg) i.v in 100 ml saline over 15 minutes, 1 hr before surgery and PCM 1g +I.V Ketorolac 30mg before induction
Patients will be assessed for 24 hrs fentanyl consumption in the postoperative period. |