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Gabapentin, Dexamethasone, Paracetamol and Ketorolac combination for pain relief and opioid sparing effects in modified radical mastectomy

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062614
Enrollment
84
Registered
2024-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Gabapentin, Dexamethasone, Paracetamol, Ketorolac: Tab. Gabapentin 600mg orally and intravenous dexamethasone 0.2mg/kg will be given 1 hr before surgery. Intravenous paracetamol 1gm an

Sponsors

Parin Lalwani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of ASA physical status I and II posted for elective Modified Radical Mastectomy

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Total Intravenous Patient Controlled Analgesia (PCA) fentanyl consumption in the first 24 hours postoperatively.Timepoint: 24 hours postoperatively.

Secondary

MeasureTime frame
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 weekTimepoint: 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

Countries

India

Contacts

Public ContactMaheshwaran S

All India Institute of Medical Sciences

drparinlalwani@gmail.com9650533388

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026