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

Not yet recruiting

• Conditions: Malignant neoplasm of breast,

• Registration Number: CTRI/2024/02/062614
• Lead Sponsor: Parin Lalwani

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-21
• Last Update Posted: 2024-07-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

Patients of ASA physical status I and II posted for elective Modified Radical Mastectomy.

Exclusion Criteria

• 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.
• Limitations in understanding use of PCA pump 12.
• H/O Migraine or Chronic Pain.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Intravenous Patient Controlled Analgesia (PCA) fentanyl consumption in the first 24 hours postoperatively.	24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
1) Time for first analgesic requirement	2) Post operative pain scores at rest & during movement

Trial Locations

Locations (1)

Department of Anaesthesiology, Pain Medicine and Critical care; 🇮🇳 South, DELHI, India

Department of Anaesthesiology, Pain Medicine and Critical care

🇮🇳South, DELHI, India

Dr Parin Lalwani

Principal investigator

9650533388

drparinlalwani@gmail.com