Testing drugs for better pain relief in breast ontological studies

To Compare The Post operative Analgesia with epidural ropivacaine with or without ketamine vs magnesium sulphate for breast ontological surgeries

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/029820

Enrollment

Registered

2020-12-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Ropivacaine: ml of 0.75% ropivacaine with 0.5mg/kg ketamine through epidural route to make final volume of 8 ml using saline Control Intervention1: Magnesium: 6 ml of 0.75% ropivacaine

Eligibility

Inclusion criteria

Inclusion criteria: Female patients aged 20-70 yrs. with ASA grade I and II scheduled for elective Carcinoma breast surgeries. 2.Patients giving consent for the study.

Exclusion criteria

Exclusion criteria: Contraindications to epidural anaesthesia: Patients with spinal deformity, local infection, unstable hemodynamics, bleeding diathesis and on anticoagulants. 2. Contraindication to study drug: Allergy, hypersensitivity, mental retardation, drug abuse, cardiac, respiratory, renal, thyroid, hepatic and CNS disorder.

Design outcomes

Primary

Measure	Time frame
evaluate twenty four hour postoperative analgesic efficacy of magnesium sulphate 1mg/kg vs ketamine 0.5 mg/kg as adjunct to epidural ropivacaine alone in patients undergoing breast oncological surgery.Timepoint: On arrival in the recovery room, time will be counted as 0 hours and the patient will be evaluated for vitals, pain, side effects every 30 minutes for next 2 hours and later at 4, 6, 8, 10, 12, 24 hrs.	—

Measure

Time frame

evaluate twenty four hour postoperative analgesic efficacy of magnesium sulphate 1mg/kg vs ketamine 0.5 mg/kg as adjunct to epidural ropivacaine alone in patients undergoing breast oncological surgery.Timepoint: On arrival in the recovery room, time will be counted as 0 hours and the patient will be evaluated for vitals, pain, side effects every 30 minutes for next 2 hours and later at 4, 6, 8, 10, 12, 24 hrs.

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Secondary

Measure	Time frame
Efficacy of Magnesium as adjunct to Ropivacaine on intensity of post operative pain using Numerical Rating Score. 2)Efficacy of Ketamine as adjunct to Ropivacaine on intensity of post operative pain using Numerical Rating Score. 3)Comparison the efficacy of ketamine and magnesium on intensity of post operative pain using NRS. Timepoint: On arrival in the recovery room, time will be counted as 0 hours and the patient will be evaluated for vitals, pain, side effects every 30 minutes for next 2 hours and later at 4, 6, 8, 10, 12, 24 hrs.	—

Measure

Time frame

Efficacy of Magnesium as adjunct to Ropivacaine on intensity of post operative pain using Numerical Rating Score. 2)Efficacy of Ketamine as adjunct to Ropivacaine on intensity of post operative pain using Numerical Rating Score. 3)Comparison the efficacy of ketamine and magnesium on intensity of post operative pain using NRS. Timepoint: On arrival in the recovery room, time will be counted as 0 hours and the patient will be evaluated for vitals, pain, side effects every 30 minutes for next 2 hours and later at 4, 6, 8, 10, 12, 24 hrs.

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Countries

India

Contacts

Public ContactDr Rubinder kaur

Sri guru ram das institute of medical sciences and research

drruchisgrd@gmail.com

Outcome results

None listed

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